Job Overview
Job Description A fantastic opportunity has arisen for an Analytical R&D (Snr Scientist) to join the Global Quality Large Molecule Analytical Sciences (GQ-LMAS) team.
GQ-LMAS 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 products.
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, continuous improvement in analytical methods and techniques, and driving successful analytical execution by contract testing labs 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 and approve critical documents relating to analytics and participate as a site representative for method life-cycle related tasks.
Responsibilities
Provide analytical technical oversight working directly with external providers and internal cross-functional stakeholders to support analytical testing of large-molecule (biologics and/or vaccine) products.
Maintain significant on-site presence at external testing providers to support direct engagement and technical oversight of critical analytical testing activities.
Build and maintain strong relationships with external entities, internal operations, technology, analytical, and procurement organizations.
Collaborate with appropriate business and functional areas to conduct tier meetings and joint steering committee meetings to achieve 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 to drive continuous improvement initiatives enhancing the quality and robustness of external testing.
Identify and resolve analytical issues, deviations, and out-of-specification results from external testing labs through technical support and troubleshooting to ensure accuracy and reliability of test results.
Lead or 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 external testing sites are prepared for inspections from multiple agencies (FDA, EMA, PMDA) from an analytical technical perspective.
Author and/or review technical documents to support process performance qualification (PPQ), licensure, and regulatory technical questions.
Qualifications
Minimum Education: 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; OR Ph.D. with a concentration in biology, chemistry, biochemistry, or related science with two (2) years of relevant industry knowledge.
At least four (4) years of experience in a GXP laboratory environment in large-molecule (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 (e.g., ELISA, HPLC, CE).
Understanding of biologics analytical technology such as bioassay (e.g., ELISA, cell-based methods), chromatography (e.g., 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.
Strong organizational and project-management skills to manage 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 (e.g., 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 information management systems (LIMS).
Experience with software automation/digital systems (e.g., Veeva Vault, MEDs, IPI, Spotfire).
#J-*****-Ljbffr