Senior Manager, Stability Strategy
- Compensation
- Not disclosed
- Location
- United States
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Not specified
- Experience
- 10+ years
- Category
- Not specified
- Posted
Skills
Must have
- • 10+ years of experience within the Biotechnology, Pharmaceutical, or other highly regulated industry.
- • Demonstrated experience defining and managing stability programs across development and commercial phases of the product lifecycle.
- • Strong experience interpreting stability data to support expiry and/or retest decisions.
- • Strong working knowledge of ICH guidelines, global regulatory expectations, and statistical approaches for stability analysis.
- • Experience participating in health agency inspections.
Nice to have
- • 12+ years of experience within the Biotechnology and/or Pharmaceutical industry preferred, including at least 2 years in a stability role.
- • Experience with multiple modalities (e.g. small molecules, biologics, oligonucleotides, etc.) strongly preferred.
- • Experience managing stability programs with atypical strategies through development and into commercialization strongly preferred.
- • Strong experience writing stability reports and summaries for inclusion in INDs, BLAs, and other regulatory submissions.
- • Demonstrated ability to defend stability decisions to regulators.
- • Excellent interpersonal and communication skills and ability to influence diverse stakeholders to drive cross-functional decision-making.
- • Proficiency with Veeva, LIMS, and JMP strongly preferred.
- EDUCATION
- BA/BS in Life Sciences or related field required. Advanced degree preferred.
- CONTACTS
- Interacts with Product Quality Leads, Supply Chain, Site QC, External Quality, Global External Operations, and Analytical Partner Leads.
- SHIFT DETAILS
- Office shift (M-F 8-5)
- ONSITE, REMOTE, OR FLEXIBLE
- The role does not require time on site. The role requires significant time in virtual meetings, as well as computer-based work (data analysis, document authoring/review), which can be successfully per
- TRAVEL REQUIRED
- No regular travel requirements.
- Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as ass
Full description
Who We Are
BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.
Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.
Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.
About Technical Operations
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
SUMMARY
The Senior Manager, Stability Strategy is a senior individual contributor responsible for defining and owning stability strategies for assigned products across the product lifecycle (development through commercialization). This role operates as a product-aligned stability subject matter expert and is expected to independently design, justify, and defend stability strategies under conditions of complexity and ambiguity.
The ideal candidate brings extensive experience in stability within the pharmaceutical or biotechnology industry, with the ability to operate in a multi-modality environment and lead complex investigations and cross-functional initiatives.
RESPONSIBILITIES
Product Stability Program Execution
- Serve as primary owner of stability strategy for assigned products across development and commercial stages.
- Design and maintain stability programs including choice of study conditions (ICH long term, intermediate, accelerated, stress), testing strategies, and bracketing and matrixing approaches.