3 дня назад
Vice President, Technical Development (Biotech)
340 000 - 360 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Vice President, Technical Development (Biotech): Leading upstream, downstream, and analytical development for clinical-stage biologics through late-stage clinical development with an accent on CMC strategy, tech transfer, scale-up, and regulatory readiness. Focus on managing CDMO partnerships, guiding multi-disciplinary technical teams, and building compliant manufacturing and analytical processes for IND, BLA, NDA, and other global submissions.
Location: South San Francisco, California, United States; on-site at least three days per week
Base salary: $340,000–$360,000 annually
Company
is a clinical-stage biotechnology company developing therapies for genetically validated cardioendocrine disease targets, including severe hypertriglyceridemia and acromegaly.
What you will do
- Provide strategic and operational leadership across upstream process development, downstream process development, and analytical development.
- Lead technical development from IND-enabling work through late-stage clinical development, including process characterization, scale-up, technology transfer, and CMC readiness.
- Coordinate CDMOs and external partners to deliver process, analytical, technical transfer, and regulatory work packages.
- Develop integrated technical strategies, executable statements of work, portfolio plans, timelines, and investment recommendations.
- Lead CMC input for INDs, BLAs, NDAs, and other global regulatory filings, including authoring and reviewing CMC sections.
- Build, mentor, and retain high-performing technical development teams while overseeing budgets and cross-functional collaboration.
Requirements
- BS, MS, or PhD in chemical engineering, pharmaceutical sciences, biochemistry, chemistry, or a related field; PhD is highly desirable.
- 15–20 years of biotechnology or pharmaceutical industry experience.
- Leadership experience across at least two of upstream process development, downstream process development, analytical development, or drug product/formulation development.
- Successful experience advancing products from early development through late-stage clinical development.
- Strong understanding of GMP regulations, CMC requirements, and regulatory submissions.
- Experience managing CDMOs, external development partners, and multidisciplinary technical teams.
Nice to have
- Drug product or formulation development experience.
- Prior experience as a CMC team lead for a late-stage product.
Culture & Benefits
- Hands-on, collaborative environment with direct involvement across organizational levels.
- Full-time position with at least three days per week working on-site.
- Up to 10% travel required, with occasional peak travel periods.
- Opportunity to shape a growing technical development organization and clinical-stage pipeline.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
5 дней назад
Director, Bioprocess / Process Development – Pivotal Drug Substance
184 494 - 249 609$
5 дней назад
Director, Manufacturing Process & Technical Quality - CGT (Cell and Gene Therapy)
184 600 - 277 000$
3 дня назад
Head of Platform Technologies, MSAT Recombinant Mammalian Drug Substance CoE (Biopharma)
178 500 - 257 833$
5 дней назад
Project Engineer, Strategic Development (Biotech)
5 дней назад
Principal Engineer - Product Investigations (AI/ML)
188 000 - 240 000$
6 дней назад