5 дней назад
Associate Director, Formulation Development (Biologics)
155 000 - 201 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Director, Formulation Development (Biologics): Designing and optimizing biologics drug product formulations, including high-concentration systems for subcutaneous delivery, with an accent on analytical characterization, stability, and structure–function relationships. Focus on defining formulation design space, leading candidate selection and developability assessments, supporting regulatory documentation and technology transfer, and mentoring junior scientists.
Location: Hybrid role based out of the Bridgewater, New Jersey office, with remote work most of the time and in-person collaboration as needed. Occasional travel of approximately 5%–15% is required.
Salary: $155,000–$201,500 annual.
Company
is a global biopharmaceutical company developing treatments for serious and rare diseases.
What you will do
- Lead formulation development for biologic drug products, including aqueous, non-aqueous, and high-concentration systems for subcutaneous delivery.
- Optimize excipients, buffers, stabilization strategies, and formulation design spaces through forced degradation and stress studies.
- Lead analytical characterization of biologic molecules and formulations, including higher-order structure, aggregation, particle formation, viscosity, and colloidal behavior.
- Investigate degradation pathways, structure–function relationships, and critical quality attributes; develop, qualify, and implement analytical methods.
- Provide technical leadership for formulation strategy, candidate selection, developability assessments, comparability, stability strategy, and lifecycle management.
- Prepare and approve technical reports, protocols, regulatory documentation, and technology transfer activities with manufacturing sites and CDMOs.
Requirements
- PhD with at least 2 years of formulation development experience, or MS with at least 6 years of experience.
- Demonstrated experience in biologics drug product formulation development using aqueous and/or non-aqueous systems.
- Advanced analytical experience with techniques such as chromatography, spectroscopy, light scattering, and calorimetry.
- Strong expertise in biologics characterization, including SEC, DLS, DSC, and spectroscopy methods.
- Strong understanding of protein stability, degradation mechanisms, and structure–property relationships.
- Experience supporting both early- and late-stage development programs.
Nice to have
- Degree in Pharmaceutics, Chemistry, Chemical Engineering, Biochemistry, or a related discipline.
- Experience mentoring or leading junior scientists or technical staff.
- Hands-on experience with CDMOs and external development partners.
- Familiarity with IND, IMPD, and BLA filings and regulatory expectations.
- Scientific and technical leadership across drug product formulation, characterization, and the product lifecycle.
Culture & Benefits
- Medical, dental, vision, and mental health coverage, plus wellbeing reimbursement and an Employee Assistance Program.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) with company match, annual equity awards, ESPP participation, and company-paid life and disability insurance.
- Learning programs, LinkedIn Learning, leadership development, mentorship, networking, and employee resource groups.
- Service, recognition, volunteering, and community engagement opportunities.
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