Job Title: Scientist
Position Overview
Reporting to the Principal Scientist within the Global Analytical & External Operations team, this role is responsible for overseeing key technical operations across the commercial product portfolio. Core responsibilities include managing analytical method transfers and validations across internal and external sites, driving change controls for global testing methods and regulatory filings, managing analytical testing with contract manufacturing organizations (CMOs) and partner labs, and maintaining centralized technical knowledge across commercial operations.
Key Responsibilities
- Method Transfers & Validations: Lead and support analytical method transfers and validations in GMP Quality Control laboratories (internal and external), including drafting protocols, defining acceptance criteria, coordinating execution, writing reports, and providing routine updates to senior leadership.
- Change Control Management: Manage and support global analytical change controls related to method updates and regulatory filings.
- External Partner Oversight: Support operational relationships with external testing facilities for commercial product manufacturing and batch release. Ensure compliance with corporate quality standards and regulatory filings through robust oversight of partner lab systems, documentation, and quality agreements.
- Global Project Leadership: Coordinate cross-functional, remote, and multi-site teams across global regions with a focus on compliance, continuous improvement, and timely problem resolution.
- Team Engagement: Foster a collaborative, quality-focused work environment that supports open communication, continuous development, and high employee engagement.
Organizational Context
This role sits within the Commercial Analytical Operations unit and reports to the Principal Scientist. Operates in a highly matrixed environment, interfacing daily with Method Development, Analytical Lifecycle Strategy, internal/external GMP QC laboratories, External Manufacturing, Procurement, Supply Chain, Quality Assurance, Regulatory Affairs, and Site Operations across multi-regional locations (US and Europe).
Required Qualifications
- Bachelor's degree in Chemistry, Biological Sciences, or a related scientific discipline.
- Minimum of 5 years of professional experience within Quality, Compliance, or Technical Operations in a regulated environment.
- Solid understanding of the commercial analytical method lifecycle, including in-process, release, and stability testing for late-stage or commercial biologics.
- Proven experience managing analytical change controls within a cGMP/GDP environment.
- Hands-on experience working across cross-functional matrix teams.
- Strong familiarity with health authority regulations, quality policies, and product quality investigations.
- Excellent interpersonal and communication skills with the ability to collaborate effectively across all organizational levels.
Preferred Qualifications
- Advanced degree (MS/PhD) in Chemistry, Pharmacy, Biology, Chemical Engineering, or a related field.
- Background in developing and maintaining analytical strategies for biopharmaceutical licensure and commercialization.
- Experience authoring or reviewing global regulatory submissions.
- Direct experience participating in compliance remediation or regulatory audit follow-up activities.
- Track record of managing large, complex programs across diverse international divisions and cultures.
