Scientist II, Pharma QC Validation, Transfer and Registration (VTR)
About The Position
As a Scientist II within Pharma Validation, Transfer and Registration (VTR), you will serve as a subject matter expert supporting analytical method validation, transfer, investigation, and regulatory filings for small molecule and antisense oligonucleotide (ASO) products. This role partners closely with Quality Control, Analytical Development, Manufacturing Science, Regulatory Affairs, and external laboratories to ensure analytical methods are robust, compliant, and ready for commercial and late-stage development programs. You will lead cross-functional initiatives, provide technical oversight of contract laboratories, and drive successful execution of validation and technology transfer activities across global markets. Reporting to the Director of VTR, you will play a critical role in ensuring product quality, regulatory compliance, and lifecycle management for Biogen's portfolio.
Requirements
- Bachelor's and 7+ years, Master's and 5+ years, or PhD and 3+ years of relevant experience in analytical development, validation, technology transfer, or pharmaceutical quality. Degree should be in a scientific discipline, with chemistry highly preferred
- Extensive experience working within GMP-regulated pharmaceutical environments
- Solid working knowledge of international regulatory guidelines, such as ICH, USP, EP, JP, ChP. and experience with global regulatory filings
- Strong working knowledge of analytical techniques and instrumentation, including LC/MS, (U)HPLC, GC, Karl Fischer, dissolution, and compendial analyses
- Experience with managing cross-functional projects and project management tools for tracking and communicating progress
- Proficiency in statistical data analysis with JMP or other software
- Stakeholder communication and cross functional collaboration
Nice To Haves
- Experience with antisense oligonucleotide (ASO) products
- Experience supporting global commercial product registrations
- CMC experience
Responsibilities
- Provide subject matter expertise in analytical methodologies for small molecule and/or antisense oligonucleotide (ASO) drug substances and drug products in a GMP environment
- Design, lead, execute and coordinate analytical method validation and technology transfer activities within internal QC laboratories and external contract laboratories
- Author and review analytical procedures and validation section of regulatory filings and address the questions from the global regulatory agencies
- Author and review transfer and validation protocols/reports and perform statistical data analysis as needed
- Troubleshoot and lead complex analytical investigations; optimize methods to ensure robustness, QC suitability, and compliance with global regulatory requirements
- Evaluate, develop, validate, and implement new analytical technologies in support of late‑stage development and commercial products
- Provide technical stewardship and oversight of contract laboratories supporting multiple regulatory markets.
- Manage cross‑site and cross‑functional projects, establish timelines and priorities, communicate progress to stakeholders and leadership
- Maintain effective collaboration with QC, AD, Manufacturing, Regulatory, and Quality Assurance partners, and coach or mentor junior scientists
- Other duties as assigned
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
