| Company: | SIGA Technologies |
| Job Location: |
Corvallis - Benton County
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| Employment Type: | Full Time |
| Salary Range: | $110-120k, depending on experience |
| Benefits: | health, dental, vision, 401k, stock options, relocation |
Description: |
SIGA Technologies, Inc (www.siga.com) is seeking an innovative, motivated, and experienced pharmaceutical product development professional to support drug development at our R&D location in Corvallis, Oregon. This position will report directly to the VP of Drug Development & Manufacturing.
About SIGA:
SIGA designs and develops novel countermeasures to prevent and treat serious infectious diseases, with an emphasis on biological warfare defense. SIGA is now considered a leading drug development company in the biodefense arena. Its portfolio of existing drug candidates and its platform for developing additional countermeasures against potential agents of biological warfare are intended to fill a critical need for safe and effective treatments.
SIGA offers a challenging, dynamic environment with growth opportunity, competitive compensation, and a full benefits program.
SIGA is an Equal Opportunity Employer.
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Duties: |
The successful candidate will oversee and direct pre-clinical formulation to support drug discovery programs, formulation/process & packaging development, and CMC regulatory activities associated with some early and late stage development of small molecule products. Demonstrated scientific knowledge and abilities relevant to small molecules, as well as the drug development process, are considered essential. This person is also responsible for both strategic and tactical deliverables from the formulation/pharmaceutics field to discovery/development project teams, which includes, but not limited to, these responsibilities:
• Design, analyze, and coordinate scientific formulation and process studies for the development of clinical development candidates and commercial products.
• Provide pharmaceutical support for lead identification and optimization, and formulation support for preclinical and clinical studies.
• Oversee formulation studies, process development, technology transfer, and validation protocols and processes for formulation of cGLP and cGMP production.
• Provide product development reports and other needed documents for regulatory submissions.
• Establishment of appropriate specifications (API, DP, excipients and components).
• Authors and/or manages the assembly of expertise specific CMC sections of regulatory filings in consultation with CMO/CRO laboratories and/or manufacturing facilities.
• Provide strong technical leadership and activity management with CROs and CMOs to ensure API, drug product and related packaging operations are maintained in compliance with current GMP and regulatory requirements.
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Qualifications: |
Qualifications include:
Ph.D. in Pharmaceutics or Chemical engineering or related discipline with minimum of 8-10 years of hands-on experience in the pharmaceutical industry with relevant experience:
• Requires a thorough knowledge and understanding of the scientific principles and concepts in pharmaceutical sciences, especially oral drug absorption and delivery, and be able to apply them.
• Experience in oral insoluble drug delivery techniques and parenteral lyophilized dosage form development.
• Formulation/drug product process development, both oral and sterile and scale-up; packaging, technology transfer; cGMPs, ICH guidelines; as well as CMC content of regulatory submissions.
• CMC writing for regulatory submissions, IND/NDA, process development reports, process validation protocol and other supporting technical documents.
• CMC gap analysis and identification of critical process parameters.
• Demonstrated ability to contribute successfully in a multi-disciplinary team environment.
• Must have experience in managing diverse project activities with manufacturing facilities at different locations/CMOs.
• Strong project management experience and excellent cross-functional team leadership and participation skills.
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