Associate Principal Scientist - Biologics Inline Support

Job Description

The Global Quality Large Molecule Analytical Sciences (GQLMAS) team is accountable for the inline analytical support and product lifecycle management of Large Molecules (Vaccines and Biologics) and Cross-Modality Compounds (i.e. Antibody Drug Conjugates). This team is highly motivated, fast-paced and focused on a robust analytical testing network that enables our company’s strategic priorities to deliver life-changing products through pipeline acceleration and uninterrupted supply of commercial product.

This Biologics Inline Support position will involve method optimization, testing, troubleshooting, analytical tech transfer, and analytical procedure lifecycle (APLC) management with a focus on inline large molecule (vaccine and biologic) and separations methods (e.g. HPLC, UPLC, CE, icIEF).  The successful candidate will represent the analytical functional area on project teams and interface with our QC partners across our Company network and external partners to provide SME support where needed.

Education:

• Bachelor’s Degree (BA/BS) with a concentration in sciences with six (6) 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 four (4) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR

• PhD with a concentration in sciences with two (2) years of experience working in the field of analytical testing, development, transfer, and/or validation.

Key Responsibilities:

• Act as an analytical subject matter expert (SME) and global Method Owner to troubleshoot and optimize analytical methods, with a focus on separations assays (e.g. liquid chromatography (HPLC, UPLC), capillary electrophoresis (CE), imaged capillary isoelectric focusing (icIEF))

• Maintain broad experience across diverse separations and biochemical assays with the ability to design experiments, analyze data, and implement functional solutions

• Collaborate with cross-functional teams to ensure successful QC-to-QC tech transfer of analytical methods

• Provide technical leadership and mentorship to junior scientists and team members

• Large Molecule Analytical Procedure Lifecycle (APLC) activities across various franchises and analytical platforms, including leading Gap Assessments and Method Standardizations

• Support various biologics and/or vaccine post-marketed CMC regulatory submissions

• Lead/support complex technical investigations and drive resolution of analytical technical issues

• Lead strategic initiatives within departmental and cross-functional teams representing GQLMAS

Required Experience | Knowledge | Skills:

• In-depth expertise with separations techniques specifically HPLC, UPLC, CE, icIEF, and other separations-based assay technology for large molecules

• Experience with Chromatography Data Systems (e.g. Empower, Astra)

• Late-stage method development, validation, transfer, and troubleshooting

• Experience working in current Good Manufacturing Practices (cGMP) laboratory environment in the area of large molecules (vaccines, biologics) with knowledge in chromatographic analytical methods

​Preferred Experience | Knowledge | Skills:

• Authoring and review of technical documents

• Analytical execution, development, validation, and/or quality control (QC) for biologic and/or vaccine release, stability, and in-process methods.

• Ability to work objectively, independently, and within a cross-functional team and learn new techniques

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

• Self-motivated with a positive attitude and proven performance record

• Strong organizational and project management skills

• Ability to effectively identify and communicate risks

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US and Puerto Rico Residents Only:

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