Employment Opportunities
 

PharmAthene, Inc. is experiencing an exciting period of development and growth. These events have brought about the need to add additional positions to the organization. PharmAthene is currently searching for qualified candidates for the position(s) noted below. Should you wish to be considered for a certain position, please e-mail your resume (in Word format) with salary requirements to hr@pharmathene.com and note the position title and number in the “subject” line of the e-mail.

As PharmAthene’s operations are focused in biodefense, which is subject to special restrictions under International Traffic in Arms Regulations, U.S. Citizenship or U.S. Permanent Resident status may be required. PharmAthene offers a challenging, dynamic environment with growth opportunity, competitive compensation and a full benefits program. Only those candidates meeting the requirements noted below and selected for an interview will be contacted.

PharmAthene provides equal employment opportunities (EOE) to employees and applicants for employment in accordance with applicable federal, state and local laws.


UNITED STATES
 

Program Control Manager (10-006)

The Program Control Manager will serve as a key member of the Integrated Project Team (IPT) supporting both the Program Director and the Cost Account Managers (CAMs) in tracking all financial expenditures for both internal and external resources.

Responsibilities/duties may include but are not limited to:
- Works with Project Managers, Cost Account Managers (CAMs), the Program Directors and external Vendors and Subcontractors to collect, verify and integrate work scope and cost information into a project plan that supports the established Budget.
- Receives all subcontractor and Vendor invoices on a monthly basis.
- Performs initial review against subcontractor’s scope and budget.
- Prepares Proposed Monthly accounting for costs invoiced.
- Prepares CAM and Program Director Report for review and approval.
- Interfaces with accounting to ensure all entries are made consistent with CAM and PD direction while maintaining compliance with GAAP and CAS.
- Tracks all invoices against COAs and subcontractors and vendors.
- Leads the preparation of Estimates to Complete (EACs) on a quarterly basis with each CAM.
- Prepares program financial data during monthly program reviews with Program Director and CAM Reviews.
- Maintains timely and accurate key program financial data to include current funding, backlog, revenue, percent complete, profitability, unbilled revenues, outstanding accounts receivable.
- Prices any requests for equitable adjustment for modified scope or directed changes.
- Performs multiple financial cost analyses including Actual vs. budget reports at the program level and monthly Contracting Officer Authorization (COA) reports.
- Primary interface with Finance, Accounting and Billing for program related financial reporting and Profit and Loss (P&L) forecasts.

Requirements include:
Bachelors Degree. Hands on experience developing and reporting on Estimates at Completion (EACs), Estimates to Complete (ETCs). Strong background in tracking and reporting on project costs in a government contracting environment. Familiarity with Cost Accounting Standards (CAS) and Federal Acquisition Regulations (FAR)Strong command of the English language and demonstrated editing skills. Experience with Deltek Costpoint and Cognos reporting tool. Strong Microsoft Excel skills. Strong technical aptitude. Initiative and Proactive attitude. Excellent organizational, technical and creative problem solving skills. Flexible and adaptable to changing priorities. Strong interpersonal skills and sense of business ethics. Excellent time management and organizational skills and attention to detail. Excellent interpersonal and communication skills.

Senior Bioanalytical Scientist (10-004)

Responsible for directing various immunologic/bioanalytical activities for PharmAthene’s product portfolio. Includes the selection, oversight and management of subcontractors performing assay development and validation as well as data analysis and reporting of test sample analyses.

Responsibilities/duties may include but are not limited to:
- Provide oversight and direction to subcontractors regarding design and development of immunoassays, biochemical, and cell-based assays.
- Provide oversight and direction to the identification and selection of contract laboratories.
- Ensure acceptable standards of work are maintained at subcontractors. Includes troubleshooting and conducting laboratory investigations into assay issues and providing guidance as to the best course of action to resolve these issues.
- Provide technical expertise for audits at immunologic/bioanalytical subcontractors.
- Provide oversight and direction to subcontractors regarding assay development, qualification, validation and tech transfer; sample testing; data analysis and reporting.
- Participate in project teams and interact with other internal or external groups, including FDA and other governmental agencies as needed in support of PharmAthene’s programs.
- Assist in the development and implementation of departmental Standard Operating Procesures (SOPs).
- Work with Program Directors and Project Managers to ensure satisfactory and timely completion of immunologic/bioanalytical assay activities.
- Work with Program Directors and Project Managers to ensure bioanalytical budgets are met.
- Preparation of technical reports and manuscripts for publication in peer reviewed journals.
- Work with Program Directors, Project Managers, and PharmAthene contracting personnel to ensure compliance with government contract requirements.
- Interact with government agencies as necessary in support of PharmAthene’s programs.

Requirements include:
Bachelors degree in related field required. Masters of Science or PHD in relevant area preferred. At least 5 years related experience in bioanalytical assay design, development, validation, and data analysis/reporting in biopharmaceutical industry and/or commercial service-provided laboratory. Thorough understanding at the bench level of immunologic/bioanalytical techniques including ELISA and cell-based functional assays. Experience working in a GLP/GMP environment. Experience with animal and potency assays an advantage. Experience with biodefense and government contracting an advantage. Strong knowledge and experience of Good Laboratory Practices. Ability to gather and analyze data and make recommendations. Ability to identify problems, research contributing factors, and develop and implement recommendations for resolution in a proactive problem solving approach. Ability to handle multiple priorities, manage projects and deliver on or before dates required and within an allocated budget.

Quality Specifications and Standards Specialist (10-002)

Assists manager with the writing, implementation, and maintenance of specifications and supporting documentation in accordance with procedures and U.S. FDA cGMP. Assists manager in tasks associated with the management of reference standards used for stability, clinical, and other analytical programs.

Responsibilities/duties may include but are not limited to:
- Assists with the maintenance and creation of specifications, specification justification reports, and SOPs associated with specification management.
- Assists with the creation of reference standard qualification protocols, reports, SOPs and COAs.
- Assists with the QC review of reference standard data generated by CROs for cGMP compliance.
- Interacts effectively with company management, internal departments, CMOs and CROs when required.
- Assists with analytical data interpretation and troubleshooting for reference standard qualifications and requalifications.
- Other duties, as assigned.

Requirements include:
BS in Chemistry, Biology or Life Science discipline preferred. Experience in a CMO/CRO environment preferred. 2+ years of experience in a quality role within the biotech or pharmaceutical industry. Previous experiences with vaccines a plus. Proficiency in other compliance disciplines, i.e., cGLPs, cGMP, GxPs. Broad knowledge of analytical and bio-analytical methodologies (i.e. HPLC, GC/MS, SDS PAGE, and ELISA). Working knowledge of multiple pharmacopoeia (i.e. USP, EP, and JP). Excellent written and verbal communication skills. Excellent time management skills demonstrating the ability to manage and prioritize multiple tasks; Ability to adjust to ever changing priorities. Working knowledge of regulations and industry guidelines (i.e. 21 CFR and ICH). Strong analytical skills with a strong focus on quality. Ability to perform assigned tasks with minimum guidance (i.e. self starter). Experience with Microsoft based applications, and ability to learn internal computer systems. Flexibility and ability to adjust to changing priorities and unforeseen events; excellent time management skills. Ability to interact professionally at multiple levels within a client oriented organization.

Stability Coordinator (10-001)

Manage ICH and GxP compliant stability programs for Company’s Phase I/II products. Coordinate stability studies, track testing time points, and ensure samples have been put on test. Work with QA/QC management to ensure appropriate scheduling of sample testing. Author stability protocols and final reports. Analyze, summarize, and trend resulting data. Report stability data as requested for any internal and/or external filings, including those to regulatory filings and government contracts.

Responsibilities/duties may include but are not limited to:
- Coordinate and execute stability studies for Company’s Phase I/II products.
- Author stability protocols and final reports.
- Track time points for testing, ensure samples are shipped to contract laboratories for testing.
- Analyze, summarize, and trend resulting data.
- Maintain working knowledge of PharmAthene SOPs, relevant GxP regulations and ICH guidelines.
- Collaborate closely with technical personnel and with other quality organizations within PharmAthene.
- Assist with regulatory inspections or corporate audit activities.
- Other duties as assigned.

Requirements include:
BS in Chemistry, Biology or Life Science discipline preferred. Background/experience in analytical chemistry, biological methods and stability investigations highly preferred. 5+ years of experience in Quality role within the biotech or pharmaceutical industry. 5+ years specifically in Stability Coordination. Experience in drug development, clinical research, regulatory compliance, clinical study monitoring or equivalent. Proficiency in other compliance disciplines, i.e., GLPs, GDP, GxPs. Competent with strong problem solving and negotiation skills. Ability to interact professionally at multiple levels within a client oriented organization. Excellent organizational and analytical skills. Excellent written and verbal communication skills. Ability to manage multiple and varied tasks, and prioritize workload. Ability to work professionally with highly confidential information. Experience with Microsoft based applications, and ability to learn internal computer systems. Flexibility and ability to adjust to changing priorities and unforeseen events; excellent time management sills. Ability to diplomatically address sensitive issues confidentially and professionally. Ability to work consistently in a fast-paced environment. Working knowledge of regulations. Broad knowledge of the drug development process, ICH, GxP guidelines, and applicable regulations is essential. Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.

Project Scheduler (09-071)

The Project Scheduler will work as an integral part of the project management team creating, maintaining, and monitoring the project Integrated Master Schedule (IMS).

Responsibilities/duties may include but are not limited to:
- Serves as support on at least one major ANSI EVM programs/contracts working with multiple control account managers and program manager with varying skill levels (i.e. CMC manufacturing managers, Clinical & Non-Clinical managers, etc.).
- Support efforts for establishing the baseline schedule, using an established Work Breakdown Structure (WBS).
- Maintains the schedule baseline, report schedule status and variances.
- Updates the schedule statuses and has ability to resource load if desired and assess schedule risk using the schedule and schedule-related metrics.
- Required to maintain and provide weekly and monthly variance analysis and be able to work with an Integrated Product Team (IPT) to gather schedule requirements, dependencies and activities.
- Required to perform analysis to determine alternative courses of action or recovery on slipped schedules.
- Determines critical path activities and expected completion dates.
- Interface with customers, managers and operation leads, as well as the financial control/EVM analyst.
- Generate straw man IMP/IMS models working independently from RFP data including the proposed Statement of Work (SOW).

Requirements include:
Bachelor’s degree in Business, Science, Technical or Project Concentration. 5+ years experience directly related to scheduling and planning, preferably in a pharmaceutical or biodefense environment. PMP Certification would be a plus. Familiarity with basic Defense Contracting. Demonstrated command of MS Project, Gantt Charts and Work Breakdown Structures (WBS). Strong or advanced understanding of EVM (Earned Value Management) and Defense requirement. Hands on experience analyzing schedule variances to include Schedule Variance (SV) and Schedule Performance Index. Experience assisting Program Managers and CAMS in Vertical Integration of upper and lower tiered schedules. Understanding or experience with Update For Project (UDFP) web-tool for Microsoft Project. Strong command of the English language and demonstrated editing skills. Strong technical aptitude. Initiative and Proactive attitude. Excellent organizational, technical and creative problem solving skillS. Flexible and adaptable to changing priorities. Strong interpersonal skills and sense of business ethics. Excellent communication skills.

Technical Project Manager – Drug Product (09-067)

The Technical Project Manager provides cross-functional technical leadership and management of CMO’s as pertains to Drug Product Manufacture.

Responsibilities/duties may include but are not limited to:
- Schedule, track and record the progress being made by the internal subcontractors.
- Provide a true picture of the process level, the risks and the quality of the execution of the activities.
- Selection and Management of external formulation, fill finish CMOs.
- Management of the technology transfer of processes between the CMOs.
- Technical expert on the fill finish processes.
- Coordination of all communication with the external CMOs. Conference call facilitator, including action item follow up and issue resolution.
- Progress monitoring of CMO activities, and the provision of updates for communication to the NIH, including monthly reports, weekly progress reports and master Gantt and risk register updates.
- Management of interface schedule between the CMO activities and those of PharmAthene subcontractors.
- Manufacturing and supply representative on key CMO project teams.

Requirements include:
BS in Scientific Discipline required; Strong Knowledge of GMP, FDA regulations preferred. Leadership/ people management experience preferred. Project management experience preferred. 3 to 5 years experience in a cGMP manufacturing environment involved in formulation, fill and finish of Final Drug Products. Must have a technical background, preferably with liquid, suspension and freeze-dried drug products. Specific experience in technical transfer of processes between manufacturing locations. Experience with process validation of drug products. Ability to lead and manage the sub-contractors. Critical thinking and attention to detail. Independent thinker with strong organizational and planning discipline. Good team working and interpersonal skills, and must have concern for impact and be able too successfully influence others to allow them to successfully complete the job.

GMP/GLP Auditor (09-057)

Assist in the development, implementation and maintenance of a fully GxP (GMP, GLP, GMP/GLP) compliant supplier assurance program for all manufacturing, quality, nonclinical and clinical needs. Focus specifically on GMP/GLP compliance, including internal and external audits.

Responsibilities/duties may include but are not limited to:
- Assist in the development, implementation and maintainance of a fully GxP (GMP, GLP, GMP/GLP) compliant supplier assurance program for all manufacturing, quality, nonclinical and clinical needs. Focus specifically on GMP/GLP compliance, including internal and external audits.
- Overall responsibilities to qualify, oversee, monitor, disqualify, and re-qualify suppliers based upon compliance and performance metrics.
- Provide quality/technical expertise and oversight to system users and stakeholders.
- Participate in regulatory inspections and maintain working knowledge of regulatory requirements applicable to industry and product portfolio.
- Other duties as assigned.
- 50-75% travel required

Requirements include:
BS (Chemistry, Biology or other related Life Science). Comprehensive knowledge supplier assurance requirements. 3-5 years Quality Assurance experience conducting a broad range of audits including suppliers, processes, and regulatory submission documents. Biotechnology or Pharmaceutical background with Document Control and/or Document Management. Competent with strong problem solving and negotiation skills. Ability to interact professionally at multiple levels within a client oriented organization. Excellent organizational and analytical skills. Excellent written and verbal communication skills. Ability to manage multiple and varied tasks, and prioritize workload. Ability to work professionally with highly confidential information. Experience with Microsoft based applications, and ability to learn internal computer systems. Flexibility and ability to adjust to changing priorities and unforeseen events; excellent time management skills. Ability to diplomatically address sensitive issues confidentially and professionally. Ability to work consistently in a fast-paced environment. High degree of understanding and ability to apply knowledge of regulatory requirements pertaining to record management including archival of records. Broad knowledge of training requirements for GxP guidelines and applicable regulations is essential. Strong quality orientation including the ability to focus on details and adherence to standards while ethically maintaining a business perspective. Able to handle high pressure situations and constructively resolve potential conflicts.

Supplier Quality Manager (09-056)

Develop, implement, and maintain a fully GxP (GMP, GLP, GCP) compliant supplier assurance program for all manufacturing, quality, nonclinical and clinical needs. Hire and manage a staff of auditors, including GMP/GLP and GCP.

Responsibilities/duties may include but are not limited to:
- Develop, implement, and maintain a fully GxP (GMP, GLP, GCP) compliant supplier assurance program for all manufacturing, quality, nonclinical and clinical needs. Hire and manage a staff of auditors, including GMP/GLP and GCP.
- Overall responsibilities to qualify, oversee, monitor, disqualify, and re-qualify suppliers based upon compliance and performance metrics.
- Provide quality/technical expertise and oversight to system users and stakeholders.
- Participate in regulatory inspections and maintain working knowledge of regulatory requirements applicable to industry and product portfolio.
- Plan, hire, and manage Quality Systems staff in accordance to company policies and applicable laws. Responsibilities include but are not limited to: budget preparation, planning, assigning, and directing work, communicating and appraising performance on an ongoing basis, completion of timely performance reviews, rewarding and disciplining employees, addressing complaints and resolving problems.
- Minimal travel with advance notice may be required.
- Other duties as assigned.

Requirements include:
BS (Chemistry, Biology or other related Life Science). 7+ years of experience in Quality Assurance within the biotechnology or pharmaceutical industry. 5+ years specifically in Supplier Assurance. 3+ years minimum management/supervisory experience. Proficiency in other compliance disciplines, i.e., cGMP, GLPs, GCP, GxPs. Comprehensive knowledge supplier assurance requirements. Biotechnology or Pharmaceutical background with Document Control and/or Document Management. Competent with strong problem solving and negotiation skills. Ability to interact professionally at multiple levels within a client oriented organization. Excellent organizational and analytical skills. Excellent written and verbal communication skills. Ability to manage multiple and varied tasks, and prioritize workload. Ability to work professionally with highly confidential information. Experience with Microsoft based applications, and ability to learn internal computer systems. Flexibility and ability to adjust to changing priorities and unforeseen events; excellent time management skills. Ability to diplomatically address sensitive issues confidentially and professionally. Ability to work consistently in a fast-paced environment. High degree of understanding and ability to apply knowledge of regulatory requirements pertaining to record management including archival of records. Broad knowledge of training requirements for GxP guidelines and applicable regulations is essential. Strong quality orientation including the ability to focus on details and adherence to standards while ethically maintaining a business perspective. Able to handle high pressure situations and constructively resolve potential conflicts.

Quality Training Associate (09-055)

Assists in the development or revision of overall corporate procedures, policies, guidelines as related to the Corporate Training Program to ensure continued compliance to meet U.S. FDA current Good Manufacturing Practices (cGMP) and applicable ex-US regulations.

Responsibilities/duties may include but are not limited to:
- Maintain Training Curriculum Requirements (TRCs) and training files for corporate employees.
- Maintains training materials to ensure consistency of training.
- Contribute to writing and revising supporting SOPs and processes related to training.
- Assist in preparing training materials and provide training to end users as it applies to quality systems and regulatory compliance.
- Determines appropriate approaches for training. Works with subject matter experts to find best practices to ensure effectivity.
- Provide quality/technical expertise where necessary.
- Assists in customer/industry quality system audits.
- Assist in monitoring the performance of the training program by gathering relevant data, writing and producing statistical reports on the performance of the program for review.
- Assists with auditing as needed to internal audit requirements.
- Interacts effectively with company management and internal departments and multiple locations.
- Other duties, as assigned.

Requirements include:
BS (Chemistry, Biology or other related Life Science). Strong background managing electronic document management systems in a cGMP environment such as TrackWise®, Documentum® or other validated software. 2+ years of experience in Quality Assurance within the biotechnology or pharmaceutical industry. 2+ years specifically in Training management/coordination. Proficiency in other compliance disciplines, i.e., c GMP, GLPs, GDP, GxPs. Biotechnology or Pharmaceutical background in training management/coordination. Competent with strong problem solving and negotiation skills. Ability to interact professionally at multiple levels within a client oriented organization. Excellent organizational, written and verbal communication skills. Ability to manage multiple and varied tasks, and prioritize workload. Ability to work professionally with highly confidential information. Experience with Microsoft based applications, and ability to learn internal computer systems. Flexibility and ability to adjust to changing priorities and unforeseen events; excellent time management sills. Ability to diplomatically address sensitive issues confidentially and professionally. Ability to work consistently in a fast-paced environment. Broad knowledge of training requirements for GxP guidelines and applicable regulations is essential. Strong quality orientation including the ability to focus on details and adherence to standards while ethically maintaining a business perspective. Able to handle high pressure situations and constructively resolve potential conflicts.

Quality Training Supervisor (09-054)

Oversee the Corporate Training Program and facilitate risk analysis, problem solving, and process improvement projects. Assists in the development or revision of overall corporate procedures, policies, guidelines as related to training to ensure continued compliance to meet U.S. FDA current Good Manufacturing Practices (cGMP) and applicable ex-US regulations.

Responsibilities/duties may include but are not limited to:
- Assist in the design, implementation, oversight, improvement of the corporate training program in compliance and accordance to regulations and Corporate policy.
- Maintaining Training Curriculum Requirements (TRCs) and training records for corporate employees.
- Implement and maintain global training program.
- Write and revise supporting SOPs and processes related to training.
- Identify training needs and provide training for end users as it applies to quality systems and regulatory compliance.
- Provide quality/technical expertise and oversight where necessary.
- Assists in customer/industry quality system audits and requests for corrective actions for training.
- Monitoring performance of the training program by gathering relevant data, writing and producing statistical reports on the performance of the program for review and as a basis for improvement.
- Implements systems for managing the training program including training materials.
- Assists with auditing as needed to internal audit requirements.
- Interacts effectively with company management and internal departments and multiple subcontractor locations.
- Track and trend the training program.
- Other duties, as assigned.

Requirements include:
BS (Chemistry, Biology or other related Life Science). Strong background managing electronic document management systems in a cGMP environment such as TrackWise®, Documentum® or other validated software. 5+ years of experience in Quality Assurance within the biotechnology or pharmaceutical industry. 5+ years specifically in Training management/coordination. Supervisory experience. Proficiency in other compliance disciplines, i.e., c GMP, GLPs, GDP, GxPs. Biotechnology or Pharmaceutical background in training management/coordination. Competent with strong problem solving and negotiation skills. Ability to interact professionally at multiple levels within a client oriented organization. Excellent organizational, written and verbal communication skills. Ability to manage multiple and varied tasks, and prioritize workload. Ability to work professionally with highly confidential information. Experience with Microsoft based applications, and ability to learn internal computer systems. Flexibility and ability to adjust to changing priorities and unforeseen events; excellent time management sills. Ability to diplomatically address sensitive issues confidentially and professionally. Ability to work consistently in a fast-paced environment. Broad knowledge of training requirements for GxP guidelines and applicable regulations is essential. Strong quality orientation including the ability to focus on details and adherence to standards while ethically maintaining a business perspective. Able to handle high pressure situations and constructively resolve potential conflicts.

Quality Documentation Associate (09-053)

Assists in the development or revision of overall corporate procedures, policies, guidelines as related to Change Management, Document Control and Archival to ensure continued compliance to meet U.S. FDA current Good Manufacturing Practices (cGMP) and applicable ex-US regulations.

Responsibilities/duties may include but are not limited to:
- Assist in the design, implementation, oversight, improvement or the corporate change management, documentation management and archival in compliance and accordance to regulations and Corporate policy.
- Maintains filing system for all controlled documents including test methods, specification, master and executed production records, SOPs, and product packaging labeling.
- Implements systems for managing change control, document tracking, controlled document distribution and records management.
- Write and revise supporting SOPs and processes related to change management, documentation management and archival.
- Identify areas for improvement and provide training for end users as it applies to change management, documentation management and archival.
- Provide quality/technical expertise and oversight where necessary.
- Assists in customer/industry quality system audits and requests for corrective actions for change management, documentation management and archival.
- Monitoring performance by gathering relevant data, writing and producing statistical reports on the performance of the program for review and as a basis for improvement.
- Maintains filing system for protocols and reports.
- Assists with auditing as needed to internal audit requirements.
- Provides change control information for review.
- Interacts effectively with company management and internal departments and multiple subcontractor locations.
- Track and trend document control, change control, deviations, investigations and CAPAs.
- Other duties, as assigned.

Requirements include:
BS (Chemistry, Biology or other related Life Science) Comprehensive knowledge of change control, document management systems and record retention practices. Strong background managing electronic document management systems in a cGMP environment such as TrackWise®, Documentum® or other validated software preferred. 2-5 years of experience in Quality Assurance within the biotechnology or pharmaceutical industry. 2-5 years specifically in change management, documentation management and archival. Proficiency in other compliance disciplines, i.e., GLPs, GDP, GxPs. Biotechnology or Pharmaceutical background in change management, documentation management and archival. Competent with strong problem solving and negotiation skills. Ability to interact professionally at multiple levels within a client oriented organization. Excellent organizational, written and verbal communication skills. Ability to manage multiple and varied tasks, and prioritize workload. Ability to work professionally with highly confidential information. Experience with Microsoft based applications, and ability to learn internal computer systems. Flexibility and ability to adjust to changing priorities and unforeseen events; excellent time management skills. Ability to diplomatically address sensitive issues confidentially and professionally. Ability to work consistently in a fast-paced environment. Broad knowledge of change management, documentation management and archival. requirements for GxP guidelines and applicable regulations is essential. Strong quality orientation including the ability to focus on details and adherence to standards while ethically maintaining a business perspective. Able to handle high pressure situations and constructively resolve potential conflicts.

Quality Documentation Supervisor (09-052)

Oversee the corporate Change Management, Document Control and Archival; facilitate risk analysis, problem solving, and process improvement projects. Assists in the development or revision of overall corporate procedures, policies, guidelines as related to documentation and archival to ensure continued compliance to meet U.S. FDA current Good Manufacturing Practices (cGMP) and applicable ex-US regulations.

Responsibilities/duties may include but are not limited to:
- Assist in the design, implementation, oversight, improvement or the corporate change management, documentation management and archival in compliance and accordance to regulations and Corporate policy.
- Maintains filing system for all controlled documents including test methods, specification, master and executed production records, SOPs, and product packaging labeling.
- Implements systems for managing change control, document tracking, controlled document distribution and records management.
- Write and revise supporting SOPs and processes related to change management, documentation management and archival.
- Identify areas for improvement and provide training for end users as it applies to change management, documentation management and archival.
- Provide quality/technical expertise and oversight where necessary.
- Assists in customer/industry quality system audits and requests for corrective actions for change management, documentation management and archival.
- Monitoring performance by gathering relevant data, writing and producing statistical reports on the performance of the program for review and as a basis for improvement.
- Maintains filing system for protocols and reports.
- Assists with auditing as needed to internal audit requirements.
- Provides change control information for review.
- Interacts effectively with company management and internal departments and multiple subcontractor locations.
- Track and trend document control, change control, deviations, investigations and CAPAs.
- Other duties, as assigned.

Requirements include:
BS (Chemistry, Biology or other related Life Science). Comprehensive knowledge of change control, document management systems and record retention practices. Strong background managing electronic document management systems in a cGMP environment such as TrackWise®, Documentum® or other validated software preferred. 5+ years of experience in Quality Assurance within the biotechnology or pharmaceutical industry. 5+ years specifically in change management, documentation management and archival. 1-3 years supervisory experience. Proficiency in other compliance disciplines, i.e., cGMP, GLPs, GDP, GxPs. Biotechnology or Pharmaceutical background in change management, documentation management and archival. Competent with strong problem solving and negotiation skills. Ability to interact professionally at multiple levels within a client oriented organization. Excellent organizational, written and verbal communication skills. Ability to manage multiple and varied tasks, and prioritize workload. Ability to work professionally with highly confidential information. Experience with Microsoft based applications, and ability to learn internal computer systems. Flexibility and ability to adjust to changing priorities and unforeseen events; excellent time management skills. Ability to diplomatically address sensitive issues confidentially and professionally. Ability to work consistently in a fast-paced environment. Broad knowledge of change management, documentation management and archival. requirements for GxP guidelines and applicable regulations is essential. Strong quality orientation including the ability to focus on details and adherence to standards while ethically maintaining a business perspective. Able to handle high pressure situations and constructively resolve potential conflicts.

Quality Assurance Associate – RTP (09-050)

Assists Quality Analytical Manager with PharmAthene related activities in RTP, NC to ensure that product is developed, manufactured, and released to meet U.S. FDA current Good Manufacturing Practices (cGMP). Assists with the development, qualification, and validation of analytical methods. Assists with relevant quality analytical tech transfer processes to internal/external partners.

Responsibilities/duties may include but are not limited to:
-Reviews analytical data and supporting data associated with analytical tech transfer, in-process and drug substance data to ensure GMP compliance.
- Reviews QC laboratory data for accuracy and compliance with GMPs.
- Maintain working knowledge of PharmAthene SOPs.
- Interact with QA colleagues at other locations to ensure consistency in application of the Corporate QA Strategy and to promote standardization within the QA group.
- Perform tasks relevant to the quality analytical tech transfer processes to internal/external partners as assigned.
- Assist with regulatory inspections and maintain working knowledge of current regulatory requirements applicable to the industry and location.
- Ensure that assigned tasks are performed on time to facilitate product delivery.
- Other duties as assigned.

Requirements include:
BS (Chemistry, Biology, or Life Science). Experience in a CMO/CRO environment preferred. Experience with vaccine production preferred. 2+ years of experience in a quality role within the biotech or pharmaceutical industry. 2+ years experience in analytical method development/validation/testing working in a GMP environment. Broad knowledge of analytical and bio-analytical methodologies (i.e. HPLC, GC/MS, SDS PAGE, ELISA, and PCR). Working knowledge of multiple pharmacopoeia (i.e. USP, EP, and JP). Excellent written and verbal communication skills. Excellent time management skills demonstrating the ability to manage and prioritize multiple tasks; Ability to adjust to ever changing priorities. Working knowledge of regulations and industry guidelines (i.e. 21 CFR and ICH). Strong analytical skills and a strong focus on quality. Ability to perform assigned tasks with minimum guidance (i.e. self starter).

Process Scientist- Formulation (09-031)

The Formulation Scientist will provide hands-on technical directions for all aspects of the formulation process development and manufacturing of biologics, including formulation design, preformulation, formulation and accelerated degradation studies for formulation selection and justification. Drug substance and Drug product characterization, formulation process development validation, and process support. The individual will monitor process performance at the contract manufacturing organization (CMO) and ensure successful delivery of products with regard to time, quality and cost.

Responsibilities/duties may include but are not limited to:
- Technology and process assessment of formulation and fill processes at the CMO, preparation of appropriate CMC sections for IND, NDA and BLA submissions.
- To liaise with PharmAthene functional groups and sub-contractors to deliver the crucial program milestones.
- To provide expert advice, strategic direction and the expert technical knowledge base when dealing with sub-contractors, partners, agencies and customers.
- To maintain current technology awareness that ensures that the company is using the best of the latest process development and validation approaches.
- To provide technical oversight and support to the manufacturing group and associated subcontractors.
- To be accountable for the integrity of all process data generated, as well as its maintenance.
- Provide early identification of deviation from plans, identify technical and commercial risks, develop mitigation strategies and advise the senior management team.

Requirements include:
Masters Degree in pertinent area (chemical engineering, chemistry, biology, biotechnology, pharmaceutical sciences, etc.). 8+ years of hands on industrial experience with a Masters degree. 3+ years of hands on industrial experience with a PhD. Industrial biopharmaceutical experience preferred. A combination of education and experience with a demonstrated track record in formulation and fill of therapeutic recombinant proteins is required. Experience should include writing of CMC sections for regulatory submissions, thorough understanding of GMP and hands-on process development experience with recombinant proteins. Strict attention to detail. Excellent communication skills - both written and oral. Strong interpersonal skills. Self-motivated with a strong work ethic. Good time/priority management skills, and able to work independently and/or in a team environment.

Process Scientist- Downstream (09-030)

The Downstream Process Scientist will provide hands-on technical directions for all aspects of the downstream process development and manufacturing of biologics, including technology transfer, process validation, and process support. The individual will monitor process performance at the contract manufacturing organization (CMO) and ensure successful delivery of products with regard to time, quality and cost.

Responsibilities/Duties include:
- Technology and process assessment of upstream processes at the CMO, preparation of appropriate CMC sections for IND, NDA and BLA submissions.
- To liaise with PharmAthene functional groups and sub-contractors to deliver the crucial program milestones.
- To provide expert advice, strategic direction and the expert technical knowledge base when dealing with sub-contractors, partners, agencies and customers.
- To maintain current technology awareness that ensures that the company is using the best of the latest process development and validation approaches.
- To provide technical oversight and support to the manufacturing group and associated subcontractors.
- To be accountable for the integrity of all process data generated, as well as its maintenance.
- Provide early identification of deviation from plans, identify technical and commercial risks, develop mitigation strategies and advise the senior management team.

Requirements include:
Masters Degree in pertinent area (chemical engineering, chemistry, biology, biotechnology, pharmaceutical sciences, etc.). 8+ years of hands on industrial experience with a Masters degree. 3+ years of hands on industrial experience with a PhD. Industrial biopharmaceutical experience preferred. A combination of education and experience with a demonstrated track record in downstream processes with therapeutic recombinant proteins is required. Experience should include writing of CMC sections for regulatory submissions, thorough understanding of GMP and hands-on process development experience with recombinant proteins. Knowledge and experience with downstream processes including column chromatography, filtration, viral clearance and scale-up. Knowledge and experience with statistical applications, and design of experiment (DOE). Knowledge and experience with the design and execution of process validation protocols. Thorough understanding of cGMP requirements for large scale manufacturing, and experience with a licensed facility. Strict attention to detail. Excellent communication skills - both written and oral. Strong interpersonal skills. Self-motivated with a strong work ethic. Good time/priority management skills, and able to work independently and/or in a team environment.

Process Scientist- Upstream (09-028)

The Upstream Process Scientist will provide hands-on technical directions for all aspects of the upstream process development and manufacturing of biologics, including technology transfer, process validation, and process support. The individual will monitor process performance at the contract manufacturing organization (CMO) and ensure successful delivery of products with regard to time, quality and cost.

Responsibilities/Duties include:
- Technology and process assessment of upstream processes at the CMO, preparation of appropriate CMC sections for IND, NDA and BLA submissions.
- To liaise with PharmAthene functional groups and sub-contractors to deliver the crucial program milestones.
- To provide expert advice, strategic direction and the expert technical knowledge base when dealing with sub-contractors, partners, agencies and customers.
- Responsibilities include planning, writing and managing the execution of process validation protocols. The authoring of manufacturing and validation sections of regulatory filings will be required.
- To maintain current technology awareness that ensures that the company is using the best of the latest process development and validation approaches.
- To provide technical oversight and support to the manufacturing group and associated subcontractors.
- To be accountable for the integrity of all process data generated, as well as its maintenance.
- Provide early identification of deviation from plans, identify technical and commercial risks, develop mitigation strategies and advise the senior management team.

Requirements include:
Masters Degree in pertinent area (chemical engineering, chemistry, biology, biotechnology, pharmaceutical sciences, etc.). 8+ years of hands on industrial experience with a Masters degree. 3+ years of hands on industrial experience with a PhD. Industrial biopharmaceutical experience preferred. A combination of education and experience with a demonstrated track record in upstream processes with mammalian cell technologies, particularly monoclonal antibodies is required. Experience should include writing of CMC sections for regulatory submissions, thorough understanding of GMP and hands-on process development experience with recombinant proteins. Knowledge and experience with mammalian cell culture (e.g. CHO, NSO, etc.), E.coli fermentation, bioreactor operation, bioreactor design principles, and medium design for mammalian and bacteria cells. Knowledge and experience with statistical applications, and design of experiment (DOE). Knowledge and experience with the design and execution of process validation protocols. Thorough understanding of cGMP requirements for large scale manufacturing, and experience with a licensed facility. Strict attention to detail. Excellent communication skills - both written and oral. Strong interpersonal skills. Self-motivated with a strong work ethic. Good time/priority management skills, and able to work independently and/or in a team environment.

Regulatory Specialist (09-011)

The Regulatory Specialist assists in the preparation of regulatory submission packages and performs a critical review of all components. This person ensures the required timelines are met and that the submissions meet established regulatory and departmental requirements.

Responsibilities/Duties include:
- Participate in the creation of regulatory filings including routine correspondence, INDs, Annual Reports, Amendments, BLAs, Supplements, Orphan Drug Applications, etc.
- Support the preparation of key data packages and review of regulatory submissions needed to support on-going projects.
- Provides overall direction to the CROs to maintain the integrity of PharmAthene's non-clinical research program.
- Critically review internal and external submissions documents.
- Work with functional areas to resolve identified compliance risks within technical packages that may be used to support regulatory submissions.
- Monitor applicable current, new and emerging regulatory requirements.
- Write/assist in writing regulatory affairs SOPs as necessary.
- Contribute to the development and maintenance of regulatory compliance systems.

Requirements include:
Bachelors degree in a biological or chemical scientific field. 3+ years of experience in a regulatory role, preferably in the biotechnology industry (esp. vaccines). Strong background in preparation of submissions to CBER; knowledge of CTD format is a plus. Thorough understanding of the product development process and US regulations pertaining to development, manufacturing and distribution of biologics. Solid working knowledge of CFR's, GMPs, GCPs and GLPs. Experience with e-submission software is preferred. Knowledge and ability to use IT software technology. Strong technical aptitude. Knowledge of and ability to use IT software technology. Excellent organizational, technical and creative problem solving skills. Flexible and adaptable to changing priorities. Strong interpersonal skills and sense of business ethics. Excellent written and oral communication skills. Great attention to detail and strong editorial skills. Approximately 15% travel required.

Regulatory Manager (09-010)

The Regulatory Manager is responsible for the preparation of regulatory submissions and performs a critical review of supporting data packages. This person ensures timely preparation of organized and scientifically valid submissions and provides expertise in translating regulatory requirements into practical, workable plans.

Responsibilities/Duties include:
- Responsible for the preparation of regulatory submissions including routine correspondence, INDs, Annual Reports, Amendments, BLAs, Supplements, Orphan Drug Applications, etc.
- Coordinate the preparation key data packages and review of regulatory submissions needed to support on-going projects.
- Explain regulatory concepts and requirements to project team members.
- Monitor applicable current, new and emerging regulatory requirements.
- Critically review internal and external submission documents to assure regulatory compliance.
- Guide functional areas and project teams in the preparation of technical documents that may be used to support regulatory submissions.
- Participate on project teams as required.
- Write/assist in writing regulatory affairs SOPs as necessary.
- Contribute to the development and maintenance of regulatory compliance systems.

Requirements include:
Bachelors degree in a biological or chemical scientific field. Graduate degree in protein biochemistry, molecular biology, immunology, microbiology or a related area would be preferred. 5+ years of experience in a regulatory role, preferably in the biotechnology industry (esp. vaccines). Strong background in planning, collating data and writing submissions for CBER. Knowledge of CTD format is a plus. Thorough understanding of the product development process and US regulations pertaining to development, manufacturing and distribution of biologics. Solid working knowledge of CFR's, GMPs, GCPs and GLPs. Proven track record of successful interactions and effective communication with the FDA and other major health authorities. Experience with both US and International regulatory agencies preferred. Experience with e-submission software is preferred. Knowledge and ability to use IT software technology. Ability to identify compliance risks and escalate as required. Strong technical aptitude. Computer literate. Excellent organizational, technical and creative problem solving skills. Ability to effectively balance/prioritize issues. Strong interpersonal skills and sense of business ethics. Excellent written and oral communication skills. Able to handle high pressure situations and constructively resolve potential conflicts. Approximately 15% travel required.

Validation Director (08-008)

The Validation Director generates and revises Validation Master Plans for PharmAthene products.

Responsibilities/Duties:
Responsibilities include writing protocols and reports, revalidation strategies, master plans, and standard operating procedures. Protocol execution including sample collection, analytical testing, statistical data analysis, report preparation, and presentation of results.

Requirements include:
Bachelors Degree in Chemistry, Biology, Engineering and/or related discipline required; Masters Degree preferred. 8+ years of experience in biotechnology, pharmaceutical, and/or biomedical industry. Minimum 5 years experience interfacing with regulatory agencies (e.g. FDA, EU). Highly proficient in application of cGMP regulations (US, Canada, and EU). Strong interpersonal skills and sense of business management ethics.



 

Last Updated: 3/4/2010