Associate Principal Scientist

Job Description

We are seeking a motivated and experienced scientist to join the Vaccine BioAssay group in West Point, PA.  The position is within Global Quality Large Molecule Analytical Sciences (GQ-LMAS) and provides technical support for analytical methodologies used in testing of commercial large molecule products.

Large Molecules Analytical Sciences, within the Manufacturing Division is responsible for the commercialization of vaccine analytical techniques from Phase III through launch including transfer to commercial manufacturing sites as well as in-line analytical support to enable world-wide robust vaccine availability.   This team is highly motivated, fast-paced and focused on the rapid advancement of our company's late-stage pipeline, plus growth of existing products.  

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. 

Key Functions:

• Serve as a subject matter expert in vaccine bioassays, providing support and training for LMAS and QC laboratories globally.

• Contribute to QC investigations with strong technical troubleshooting skills and assist in developing/implementing CAPAs.

• Contribute to the Assay Procedure Lifecycle Management for vaccine ELISAs and similar assays across the large molecule portfolio including method optimization and modernization, assay performance monitoring, and optimization of workflows.

• Provide authorship or review of analytical procedures, methods transfer protocols and reports, technical reports, experimental designs and regulatory submission documents.

• Provide technical input during inspections and audits.

• Support the development of digital methods and deploying to global QC sites

Minimum Education Requirement and Experience:

• Bachelor’s Degree (BA/BS) with a concentration in sciences with eight (8) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR

• Master’s Degree (MA/MS) with a concentration in sciences with six (6) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR

• PhD with a concentration in sciences with three (3) years of experience working in the field of analytical testing, development, transfer, and/or validation.

Required:

• Experience and expertise with bioassays, specifically ELISA immunoassays or other binding-based assay technologies for large molecules.

• Experience in a current Good Manufacturing Practices (cGMP) laboratory environment in the area of large molecules (vaccines, biologics) with experience in immunochemical analytical methods.

• Development and management of project timelines and deliverables.

• Authoring and review of technical documents

• Ability to work independently and within a cross-functional team

• Good technical, communication (oral and written), interpersonal, and teamwork skills 

• Strong organizational and project management skills.

• Ability to effectively identify and communicate risks.

• Experience with drug substance and drug product release, stability and extended characterization testing for vaccines and biologics.

Preferred:

• Experience with late-stage method development, validation, transfer, and troubleshooting.

• Digital competency creating digital methods and templates, including SoftMax Pro.

• Experience with Quality and Regulatory Requirements

• Working knowledge of CMC filing requirements

• Working experience with CMOs and CROs

Required Skills:

Adaptability, Analytical Method Development, Analytical Testing, Assay Development, Biochemical Assays, Biological Assay Development, Cell-Based Assays, Communication, Cross-Functional Teamwork, Deviation Management, ELISA Techniques, Enzyme Linked Immunosorbent Assay (ELISA), External Collaboration, Good Manufacturing Practices (GMP), Immunoassays, Process Analytical Technology (PAT), Project Management, Protein Analysis, Sandwich ELISA, Teamwork, Working Independently

Preferred Skills:

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