Principal Scientist, Analytical, Quality Control
About Astellas
Astellas is a global life sciences company dedicated to transforming innovative science into value for patients. They focus on disease areas such as oncology, ophthalmology, urology, immunology, and women's health, and they pioneer new healthcare solutions for diseases with high unmet medical needs.
Purpose & Scope
The Principal Scientist for QC Analytical plays a crucial role in supporting QC Analytical operations and activities, ensuring compliance and contributing to GMP manufacturing. They are responsible for optimizing and validating analytical test methods, leading investigations, implementing CAPAs, preparing technical documents, collaborating cross-functionally, and serving as an Analytical Subject Matter Expert (SME).
Role And Responsibilities
- Ensure data integrity for all QC Analytical laboratory data and support QC equipment validation, maintenance, and calibration.
- Perform routine in-process and release QC testing of AIRM cell products.
- Oversee and execute analytical method qualifications, validations, and transfers, including drafting technical protocols, reports, troubleshooting, and optimizing existing methods.
- Complete routine record reviews of test data and related documents for in-process testing, drug substance, and drug product release and stability.
- Author, revise, and review Standard Operating Procedures (SOPs), qualification/validation protocols, and reports.
- Conduct investigations regarding out-of-specification (OOS) results, address and manage deviations, Change Requests, and CAPAs related to analytical procedures.
- Assist in the preparation of reports and data packages for interactions between AIRM and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
- Provide SME support for critical manufacturing investigations, including impact assessment, root cause analysis, and corrective/preventive actions.
- Implement commercial readiness initiatives, electronic GMP systems, and support regulatory filings and inspections.
- Evaluate new technologies and business processes for continuous improvement and commercial GMP readiness.
Required Qualifications
- PhD, MS, or BS in Cell Biology or equivalent.
- At least 6+ years of relevant experience in QC or equivalent experience in commercial pharmaceutical industry for a PhD holder; 8+ years for an MS holder; 10+ years for a BS holder.
- Strong experience in developing, optimizing, qualifying, and validating Analytical Cell-based Assays.
- Demonstrated leadership, critical thinking skills, and the ability to influence and drive milestones.
- Proven ability to work independently, prioritize, and manage multiple tasks simultaneously in a matrix environment.
- Clear and succinct verbal and written communication skills, along with strong analytical, problem-solving, critical thinking skills, and excellent organizational skills.
- Working knowledge of appropriate relevant regulatory guidance (e.g., ICH, FDA, and EMA).
- Previous experience supporting a cGMP facility.
- Experience with preparations and activities associated with site licensure, commercial readiness, and experience with Analytical Method Validation.
Preferred Qualifications
- Advanced degree desirable.
- Experience with Laboratory Information Management Systems (LIMS) implementation and maintenance.
- Ability and flexibility to work weekends.
- Excellent knowledge of GMP, ICH, USP, EU, JP, and global compendial regulations and guidance.
Location and Working Environment
This position is based in Westborough, MA and requires on-site work. It is an on-site role working in a cGMP regulated manufacturing facility. On occasion, this role may travel to other Astellas sites (0-5%).
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- Culture of growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Salary Range
$119,000 - $170,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience, and organizational equity considerations)
Benefits
- Medical, Dental, and Vision Insurance
- Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
- 401(k) match and annual company contribution
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Company paid life insurance
- Referral bonus program
Category
Massachusetts TC