Job Description
The Global Quality- Large Molecule Analytical Sciences (GQ-LMAS) team leads the global analytical technical oversight of late-stage pipeline programs through commercialization and launch as well as product lifecycle management support for 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 External Analytical position will direct and manage the analytical activities within our commercial external manufacturing and testing network. This role involves developing and implementing site-related analytical strategies, and site implementation of continuous improvement in analytical methods and techniques and driving successful analytical execution by the contract testing lab(s) to support on time batch release.
Additionally, this position will work directly with technical operations, quality, regulatory, microbiology, and analytical program leaders on a regular basis to review/approve critical documents relating to analytics and participate as a site representative for method life-cycle related tasks

MINIMUM EDUCATION REQUIRED AND EXPERIENCE:

• Bachelor’s Degree (BA/BS) with a concentration in biology, chemistry, biochemistry, or related science with six (6) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation; OR
• Master’s Degree (MA/MS) with a concentration in biology, chemistry, biochemistry, or related science with four (4) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation; OR
• PhD with a concentration in biology, chemistry, biochemistry, or related science with two (2) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation.

REQUIRED SKILLS AND EXPERIENCE:

• At least 4 years working experience in a GXP laboratory environment in the area of large molecules (vaccines, biologics) analytics or Cross-Modality Compounds.
• Experience in analytical product life cycle activities (development, validation, and /or transfer) across various large molecule analytical platforms (i.e. ELISA, HPLC, CE).
• Understanding biologics analytical technology such as bioassay (i.e. ELISA, cell-based methods), chromatography (i.e. HPLC, UPLC), and general biochemistry methods.
• Experience in the biopharmaceutical manufacturing industry, such as in biologics or vaccines commercialization, technical operations, and/or Quality control.
• Knowledge with In-Process Controls, drug substance and drug product release, stability, and extended characterization testing for vaccines and biologics
• Experience with regulatory requirements and guidelines according to ICH, USP, Ph. Eur., and JP.
• Strong organizational and project management skills to handle multiple project associated tasks simultaneously.
• Strong oral and written communication skills to effectively communicate technical information and risks to both technical and non-technical stakeholders.

Preferred Skills and Experience:

• Knowledge of deviation management and change control processes.
• Ability to analyze, interpret, and troubleshoot analytical data.
• Experience in method transfer, method validation, new product introduction, and/or analytical product life cycle activities across various large molecule franchises and analytical platforms.
• Worked and interfaced with external partners (i.e. CMOs and CTLs).
• Self-motivated with a positive, proactive, and service-oriented mindset.
• Capability to adapt and be flexible in a fast paced cross-functional team working environment.
• Experience with laboratory data management systems (i.e., LIMS).
• Experience with software automation/digital systems (e.g., Veeva Vault, MEDs, IPI, Spotfire).

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Current Contingent Workers apply HERE

REQUIRED SKILLS:

Adaptability, Adaptability, Analytical Method Development, Analytical Testing, Assay Development, Bioanalytical Analysis, Biochemical Analysis, Biochemical Assays, Biochemistry, Biopharmaceutical Industry, Biopharmaceuticals, Cell-Based Assays, Change Control Processes, Chemical Biology, Chromatographic Techniques, Cognitive Flexibility, GMP Environments, Innovative Thinking, Investigation Procedures, Laboratory Information Management System (LIMS), Nuclear Magnetic Resonance (NMR) Analysis, Process Analytical Technology (PAT), Project Management, Project Planning, Strategic Thinking {+ 1 more}

• Analytical technical oversight working directly with the external provider(s) and internal cross-functional stakeholders to support analytical testing of large molecule (biologics and/or vaccine) products.
• Position includes significant on-site presence at external testing provider(s) to support direct engagement and technical oversight of critical analytical testing activities.
• Build and maintain strong relationship with External Entities, as well as internal operations, technology, analytical and procurement organizations. Closely collaborates with appropriate business and functional areas to conduct Tier meetings, and Joint Steering Committee meetings (as applicable) to achieve our objectives.
• Collaborate with departmental and cross-functional commercial manufacturing teams to support facility start-up and sustainability activities.
• Interface with Global Analytical Working Groups and Global Method Owners/SMEs
• Drive continuous improvement initiatives to enhance the quality and robustness of external /testing through implementation of proactive tools, assay data trending, corrective actions and best practices.
• Identify and resolve analytical issues, deviations, and out-of-specification results from external testing labs through technical support of investigating and troubleshooting analytical problems to ensure the accuracy and reliability of test results.
• Lead/support complex investigations and drive resolution of analytical technical issues
• Build and manage project plans, timelines, and schedules to effectively meet project timelines and deliverables.
• Ensure our external testing sites are prepared for inspections from multiple agencies (i.e. FDA, EMA, PMDA) from an analytical technical perspective
• Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ), licensure and regulatory technical questions