Sr. Manager - Associate Director, Formulation (Drug Product)
REMOTE - Permanent
MULTIPLE OPENINGS
Competitive Compensation + excellent bonus/benefits
A world leading Biopharma organization is looking to enhance its Research and Development team with the addition of an Associate Director of Formulation.
- Formulation/Drug Product & Manufacturing CMC
- Bay Area | Boston | San Diego | RTP | REMOTE
Duties and Responsibilities
- Ensure protocols follow the company policies, cGMP and FDA regulations
- Strong communication, organization, and multitasking skills are needed to lead
- Interpret raw data, organize results, generate/review reports, and communicate findings to project teams and management
- Will oversee tech-transfers, scale-ups, and outsourced formulations
- Lead Small Molecule OR Biologics - Pipeline(Preclinical -Phase III & Commercialization)
Qualifications
- Strong hands-on experience in Drug Product/Formulations
- Experienced in formulation design, scale-up, tech transfers, & Quality by Design (QbD) studies.
- Past experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs) - highly coveted
- M.S or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 5-7 years of industry
- Experience authoring CMC sections for IND, IMPD, and NDA OR BLA is highly sought after
- Remote Option Available