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
 

Process Scientist (10-008)

The Process Scientist will provide hands-on technical directions for all aspects of the 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. As an expert in biotechnological processes, you will provide strategic process oversight through a detailed and current technical understanding of the field, particularly for formulation and fill lyophilization, providing advice to the manufacturing, specification and stability teams.

Responsibilities/duties may include but are not limited to:
- Technology and process assessment of development and manufacturing processes at the CMO, particularly in the formulation and fill processes.
- Responsible for preparation of appropriate CMC sections for IND, NDA and BLA submissions.
- To oversee the timely development and delivery of lyophilization and diluent processes from development through GMP manufacturing.
- To provide technical expertise for process development, technology transfer and process scale up for a specified product.
- 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.
- To provide technical oversight to process sub-contractors and ensure they subsequently deliver while maintaining good relations with them.
- 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. Experience of lyophilization processes and vaccine processes preferred. Anthrax experience preferred. Experience should include writing of CMC sections for regulatory submissions, thorough understanding of GMP and hands-on process development experience with recombinant proteins. Expert knowledge in biotechnology processes and products. Experience of fill finish processes and sterile processes. Ability to handle large volumes of data and multiple programs. 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 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. Able to work under pressure within tight time frames. High level of initiative. Capable of working with minimal supervision. Have a client service approach to supporting users. Able to function in multi-disciplinary team.


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 Manager of Analytical Sciences (09-031)

With expertise in analytical methods development and validation applicable to biologics, the incumbent will closely interact with PharmAthene internal teams (Process Sciences, Manufacturing, Quality, Regulatory and Program Management) and outside contractors and provide analytical support to drug development programs. Will assist in generating a good quality analytical package for in-process, release, and stability testing of drug substance and drug products suitable for CMC sections of BLA.

Responsibilities/duties may include but are not limited to:
- Provide technical leadership for analytical programs.
- Develop strong partnership with contract laboratory service providers for efficient and quality programs in analytical methods development and validation.
- Ensure that analytical methods are suitable for their intended purposes and meet the regulatory standards.
- Trouble shoot and provide guidance to contract laboratories and internal teams.
- Review and author analytical sections as needed in Govt. proposals and CMC sections.
- Keep current with technical and regulatory knowledge.
- Assist in developing in-house lab and expertise in Analytical Sciences.
- Accountable for timely methods development and validation activities in support of multiple drug/vaccine development programs.

Requirements include:
BS/MS in Chemistry/ Biochemistry or related Life Science discipline; PhD preferred. 8 – 10 years of experience in protein analysis, mostly hands on laboratory experience. 3-5 years in supervisory and project lead roles. At least 5 years in bio-pharmaceutical working under cGMP. Review and writing of technical reports. Be able to work independently. Knowledgeable in analytical techniques and instrumentation, such as HPLC, GC, SDS-PAGE, ELISA and LC/MS, etc. Excellent oral and written communication skills. Strong technical and management skills in analysis of proteins derived from microbial or mammalian cells. Demonstrated ability of maintaining objectivity and focus in resolving technical issues both internally and with contractors. 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. Ability to work with teams consisting of personnel with diverse background.


Senior 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.


Staff Accountant (10-013)

Performance of daily accounting duties relating to operations including time collection, journal entries, fixed assets, account reconciliations and assistance with monthly and year end close activities

Responsibilities/duties may include but are not limited to:
- Preparation and posting of general journal entries for fixed asset purchases and corresponding depreciation, prepaid expenses and accrued expenses.  Initial review of monthly trial balance activity
- Bank Reconciliation- Process general ledger entries for bank deposits and interest income.  Daily updates of cash flow worksheet for proper cash management.  Prepares monthly bank reconciliation for all accounts
- Time Reporting– Ensure timely recording, reconciliation and posting of timesheets.  Maintenance of the Time & Expense reporting system.  Review of bi-monthly Labor Distribution spreadsheet ensuring accuracy of information regarding employees in terms of project and department coding, and agreement to Human Resources information. Prepare Labor Distribution journal entries.
- Fixed Assets – Preparation of fixed assets reconciliation and roll-forward for monthly activities.  Quarterly preparation of SEC filing fixed asset and intangible footnotes
- Preparation of monthly balance sheet reconciliations for major accounts, (i.e. prepaids, accrued expenses, deposits, merger and financing related activities, etc.)
- Ad hoc project assistance with reporting requirements for the DCAA, SEC & EVM, along with other general accounting functions.

Requirements include:
- Associates Degree, equivalent or higher required
- Requires 5 or more years of work experience in an accounting role
- Experience with month-end, year- end closing and reconciliation is required
- Experience with Deltek Costpoint preferred
- Experience with Deltek Time and Expense preferred
- Requires strong knowledge of various Accounting software
- Knowledge of Microsoft Office applications
- Government contracting experience is a plus
- Excellent oral and written communication skills
- Demonstrated ability to maintain objectivity and confidentiality
- Ability to handle multiple priorities, manage projects and deliver on or before dates required
- Strong interpersonal skills Ability to effectively balance/prioritize issues


Senior Program Director (10-017)

The Primary purpose of the Senior Program Director is to oversee and guide the effective development plan for a specific PharmAthene product or portfolio of products. Serves as scientific and technical lead for the PharmAthene program.

Responsibilities/duties may include but are not limited to:
- Functions as scientific/technical lead for product development program
- Directs the Project Team in developing the product development strategy to ensure company objectives are accomplished.
- With input of functional VPs, coordinate the development of the program’s development timelines and budgets.
- Review and monitor program/project activities against the defined schedule and costs and manage the process of addressing issues to keep project on time and on budget.
- Provide direction and support to project/program team members from the various functional areas assigned to the specific program.
- Ensure that PharmAthene standards for quality are met.
- Partner and communicate with external collaborators to ensure smooth working relationships.
- Ensure accuracy of database information and Earned Value Management when required.
- Lead Integrated Project Team (IPT) meetings and communicate critical issues to Senior Management when necessary.
- Ensure compliance with all reporting requirements related to government contracts/grants and regulatory agencies
- Work with Proposal Manager to insure timely submission of high quality proposals for government contracts and grants.
- Collaborates with Business Development colleagues to support business development presentations, meetings and due diligence efforts when necessary.

Supervisory/Budgetary Responsibilities:
- Manages Project Manager assigned to team as necessary and appropriate
- Manages program-specific budget

Requirements include:
- MD or PhD
- Eight or more years of progressively increasing responsibility in managing product development program(s) with specific experience in managing complex, highly technical R&D/ Drug Development related activities, ideally for a pharmaceutical or biotechnology manufacturer/marketer.
- Trained/experienced in project management and proven success in managing in a matrix organization is a plus.
- Vaccine experience required
- Anthrax experience strongly preferred
- Broadly knowledgeable and deeply experienced in the product development process, ideally in recombinant proteins and vaccines.
- Successful experience in interacting with senior management of a broad range of disciplines.
- Functional experience in, but not limited to, project management, R&D, clinical development, operations.
- Particularly attractive, but not essential, would be biodefense product experience and interaction with government agencies and related bodies.
- Experience with the Earned Value Management project management technique also would be preferred


Senior Stability Coordinator (10-020)

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

Last Updated: 7/26/2010