7 дней назад
Associate Director, Formulation Development (Biologics)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Formulation Development (Biologics): Designing and optimizing biologics drug product formulations and analytical characterization strategies with an accent on high-concentration formulations, protein stability, and structure–function relationships. Focus on defining formulation design space, leading developability assessments, supporting regulatory filings, and transferring formulation processes to manufacturing sites and CDMOs.
Location: Hybrid role based out of the Bridgewater, New Jersey office, with remote work available most of the time and in-person collaboration as needed; occasional travel of approximately 5%–15%.
Company
is a global biopharmaceutical company developing therapies for patients with serious and rare diseases.
What you will do
- Design, develop, and optimize aqueous and non-aqueous biologics drug product formulations.
- Develop high-concentration formulations for subcutaneous delivery and improved patient convenience.
- Characterize excipients, buffers, stabilization strategies, protein structure, aggregation, particle formation, viscosity, and degradation pathways.
- Conduct forced degradation and stress studies to define formulation design space and support stability strategies.
- Provide technical leadership for formulation strategy, candidate selection, developability assessments, and product lifecycle activities.
- Author and approve technical reports, protocols, regulatory documentation, and support technology transfers to manufacturing sites and CDMOs.
Requirements
- PhD with at least 2 years of formulation development experience, or MS with at least 6 years of experience.
- Degree in Pharmaceutics, Chemistry, Chemical Engineering, Biochemistry, or a related discipline.
- Demonstrated experience in biologics drug product formulation development.
- Advanced analytical characterization expertise, including chromatography, spectroscopy, light scattering, calorimetry, SEC, DLS, and DSC.
- Strong understanding of protein stability, degradation mechanisms, structure–property relationships, and critical quality attributes.
- Experience with early- and late-stage development programs, CDMOs, external partners, and regulatory filings such as IND, IMPD, and BLA.
Nice to have
- Experience mentoring or leading junior scientists or technical staff.
- Strategic thinking across the product lifecycle and a strong quality and regulatory mindset.
- Ability to operate effectively in a fast-paced, matrixed environment.
Culture & Benefits
- Purpose-driven work focused on serious and rare diseases.
- Flexible work schedules with purposeful in-person collaboration.
- Medical, dental, vision, and mental health coverage, plus annual wellbeing reimbursement and an Employee Assistance Program.
- Paid time off, fertility and family-forming benefits, caregiver support, and company-paid life and disability insurance.
- 401(k) matching, annual equity awards, an Employee Stock Purchase Plan, learning programs, mentorship, and employee resource groups.
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