Sr. Scientist, Analytical External Capabilities, Biologics (Hybrid)

Job Description

The selected candidate will work in the Pharmaceutical Analysis & Digital Technologies (PADT) department within the Development Sciences and Clinical Supplies (DSCS) organization and serve as a primary point of contact for externalized analytical deliverables supporting Biologic development programs at various stages of development. The scope of the role will include realization of the analytical R&D externalization strategy by building analytical capabilities and driving a culture of scientific and operational excellence at our external partners including oversight of a rapidly growing team of external analysts. The candidate will partner with cross functional Development and Commercialization Teams (DCT’s) and external partners to establish timelines for drug substance and drug product deliverables and will provide oversight of method development, method transfer, as well as release and stability testing for multiple programs. The candidate will also partner with Bioprocess, Quality, and interdivisional stakeholders to grow our relationships with select vendors by leveraging our company’s ways of working and transform them into strategic partners. This role represents an excellent opportunity for a scientist or engineer seeking to gain externalization experience, lead the capability build at an external partner, provide oversight to multiple programs, and broaden their experience in biologics development. 

Primary Responsibilities: 

• Execution of AR&D’s externalization strategy and optimization of the operating model to deliver results aligned with enterprise goals. 

• Partner with cross functional DCT’s, WG’s (Working Groups), Bioprocess Research & Development External Capabilities, and TPQM (Third Party Quality Management) to manage externalized projects. 

• Lead analytical development for all biologic drug substance and drug product deliverables sited at selected external partners including testing, analytical method qualifications/transfers, technical oversight, and resolution of analytical issues. 

• Lead and apply project management skills to analytical method validation and transfer activities for pipeline commercialization projects, ensuring testing site readiness. 

• Lead analytical capability build at selected external partners by identifying focus areas that support our company's current and future pipeline and working closely with internal SMEs to upskill external partners. 

• Partner with internal AR&D stakeholders to author technical protocols, reports, and review technical documents.  

• Ensure high quality documentation from external partners consistent with a compliance mindset. 

Education Minimum Requirements: 

Applicants must hold one of: 

• Ph.D. in Chemistry, Pharmaceutical Science, or related discipline  

• Master’s degree with a minimum of 3 years of experience 

• Bachelor’s degree with a minimum of 5 years of experience 

Preferred Experience & Skills:  

• Outstanding communication, critical thinking, and leadership skills. 

• Effective interpersonal skills and demonstrated ability to overcome challenges and align stakeholders toward a common goal. 

• Project management experience including resource management, budget forecasting, and risk assessment/mitigation planning.  

• Experience working independently in a fast-paced and dynamic environment and navigating competing priorities. 

• Strong knowledge of biologics CMC landscape including knowledge of GMP, ICH and relevant HA guidelines. 

• Strong understanding of regulatory validation guidelines and prior experience of successfully implementing validation best practices. 

• Experience with a wide variety of analytical methods, including biochemical and biophysical characterization.