Group Leader - Formulation & Process Development 

SIGA Technologies, Inc (www.siga.com) is seeking a Group Leader - Formulation & Process Development to join the team at our Research & Development location in Corvallis, Oregon.

Principal job duties will include:

• Assist and guide the group in formulation development activities both for new products and new technologies
• Train formulation group members on different techniques and stages of product development
• Provide development reports and other needed documents for regulatory submissions.
• Interact with technical and project teams
• Establish appropriate formulation development processes using statistical design and related concepts
• Lead the design, selection and successful implementation of the product formulation, configuration, process characterization and process validation in collaboration with analytical scientists, outside vendors, contract manufacturing, QC, QA, RA and PK/PD departments
• Interface with R&D Group, Regulatory Affairs, Quality and contract manufacturing units to support the development, manufacture of innovative product formulations.
• Supervises:   2 other employees

Qualifications include:

Ph.D. in pharmaceutical science or chemistry and one year relevant experience; or Masters and four years relevant experience.  Experience must include the following skill sets: 

• Sterile and solid pharmaceutical development, process transfer, pre-formulation techniques and the use of experimental design.
• Batch records writing and review.
• Review analytical data from HPLC, assessing stability data and writing specifications.
• Drug development process, process validation, GMP, CMC and regulatory requirements.
• CMC writing for regulatory submissions, process development reports, process validation protocol and other supporting technical documents.
• CMC gap analysis and identification of critical process parameters.
• CGMP manufacturing, CMC regulatory NDA and IND writing and clinical stage formulation development of various dosage forms including sterile and solid dosage forms.

Acronym definitions:  CGMP - current Good Manufacturing Practices; CMC - Chemistry Manufacturing and Control; NDA - New Drug Application; IND - Investigational New Drug; HPLC - High Performance Liquid Chromatography 

Wage:  $30,000 annual 

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 is an Equal Opportunity Employer. 

Interested applicants should submit their resume for consideration to careers@siga.com