Senior Scientist, Analytical R&D

Merck•South San Francisco, CA

1d•$117,000 - $184,200•Hybrid

About The Position

Global Quality Large Molecule Analytical Sciences (GQ- LMAS), in our Manufacturing Division, is accountable for the commercialization of large molecule, vaccines and biologics, analytical techniques from Phase III through launch and transfer to supply. This team is highly motivated, fast-paced and focused on the rapid advancement of our Company's large molecule pipeline, plus growth of existing products. This position will involve oversight of late-stage method development, validation, and life-cycle management of methods with a focus on both global method transfer activities and external analytical. From a Global Quality Large Molecule Analytical Sciences (GQ-LMAS) Analytical Transfer perspective, this position includes activities such as interfacing with a global network of product manufacturing and testing sites, collaborating with product development groups within our manufacturing division and our Research Laboratories division, continuous improvement of analytical methodology, assay validation, analytical technical transfer, and Biologics License Application preparation. From a GQ-LMAS External Analytical perspective, this position includes directing and managing 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.

Requirements

Bachelor’s degree in biology, chemistry, biochemistry, or related science with six (6) years of relevant industry knowledge in systematic development, validation, and/or quality control (QC)
Master’s degree in biology, chemistry, biochemistry, or related science with four (4) years of relevant industry knowledge in systematic development, validation, and/or quality control (QC)
PhD in biology, chemistry, biochemistry, or related science with one (1) year of relevant industry knowledge in systematic development, validation, and/or quality control (QC)
Knowledge of ICH, USP and other compendial chapters required for method transfer and validation.
Knowledge with late-stage method development, validation, and transfer
Experience with management of contract manufacturing organizations
Minimum two (2) years working knowledge in a current Good Manufacturing Practices (cGMP) laboratory environment in large molecules (vaccines, biologics)
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.
Development and management of project timelines and deliverables
Participation in cross-functional project teams
Authoring and review of technical documents
Ability to work objectively and within a cross-functional team
Ability to learn new techniques
Technical, verbal, and written communications, stakeholder management, and teamwork skills
Self-motivated with a positive attitude and proven performance record
Knowledge with drug substance and drug product release, stability, and extended characterization testing for vaccines and biologics
Strong organizational and project management skills
Ability to effectively identify and express risks

Nice To Haves

Worked and interfaced with external partners (i.e. CMOs and CTLs).
Deviation management and change control processes
Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ)
Ability to analyze, interpret, and troubleshoot analytical data.
Global launch or supply experiences
Supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA)
Continuous improvement or lean six sigma methodology
Experience with laboratory data management systems (i.e., LIMS).
Experience with software automation/digital systems (e.g., Veeva Vault, MEDs, IPI, Spotfire).

Responsibilities

Lead method transfers and/or validations across vaccine and biologics programs including quality risk assessments/gap analysis.
Provide sponsorship of both in-line and pipeline analytical methods. The candidate will interface across our Company network and external partners to ensure the successful commercialization of assays promoting our pipeline programs
Involvement in development, troubleshooting and optimization of analytical methods
Continuous improvement using laboratory standardization, lean laboratory, and six sigma methodology
Assay Life Cycle activities across various large molecule franchises and analytical platforms
Promote various vaccine and/or biologics registrations, launches, and troubleshooting activities external to the US, including documentation preparation
Direct strategic initiatives within departmental and cross-functional teams representing Global Quality Large Molecule Analytical Sciences (GQ- LMAS).
Manage global registration and test on importation (TOI) activities
Collaborating with commercial manufacturing teams to support facility start-up activities, New Product Introduction and provide analytical support both within our Company network and at contract manufacturing organizations (CMOs) or contract testing laboratories
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.