Senior Director, Process Development
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide overall management and direction to the Upstream (USP), Downstream (DSP), and formulation/filling (F/F) process development scientists.
- Oversee drug substance and drug product process development (Fermentation/Cell Culture, Purification, and Formulation), manufacture of clinical supplies, and development of efficient scalable manufacturing processes, according to regulatory requirements to support Chemistry, Manufacturing and Controls (CMC) (Investigational New Drug Applications (INDs), Investigational Medicinal Product Dossiers (IMPDs), Biologics License Applications (BLAs)).
- Spearhead process development and technology transfer of vaccines and therapeutics within a Contract Development and Manufacturing Organization (CDMO) environment.
- Lead technology innovation initiatives to create intellectual property.
- Plan/organize/control workflow and resource allocation. Manage and monitor department’s annual budget. Manage process development activities to ensure delivery on schedule.
- Design/implement development plans for manufacturing processes.
- Direct process development and product formulation of avian cell-based vaccine production.
- Partner with Project Management to develop key milestones, project budgets and timelines.
- Supervise and lead a technical team of 10-15 scientists and engineers.
- Work with government agencies (CDC, NIH, NIAID).
- Use Current Good Manufacturing Practice (cGMP) and relevant regulatory guidance (i.e. ICH, FDA, and EMA) to conduce product development work.
- National and International travel is expected 25%.
QUALIFICATIONS AND REQUIREMENTS:
- PhD in Biology, Biochemistry, Biotechnology or related Life Sciences discipline, plus 10 years of experience in the pharmaceutical and/or biotechnology industry with 5 years leadership and team management experience in biologics process development within viral vectors and gene therapy.
Experience must include:
- 10 years of drug product and process development (Fermentation/Cell Culture, Purification, and Formulation), manufacture of clinical supplies, development of efficient and scalable manufacturing processes to support regulatory filing CMC (INDs, IMPDs, BLAs).
- Technical & scientific experience in viral based production, in particular viral based production on avian cell line (primary and continuous cell lines).
- Experience in process development of viral based vaccines and therapeutics working with CDMO environment
- Experience working with government agencies
- Must have worked in cGMP environment following relevant regulatory guidelines (i.e. ICH, FDA, and EMA).
IDT Biologika Corporation is an Equal Opportunity Employer:
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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