Senior Scientist, Analytical Research and development job at Merck in San Francisco, CA, Los Angeles, CA, Oakland, CA, Palo Alto, CA

Title: Senior Scientist, Analytical R&D

Location:

remote type

Hybrid

locations

USA - California - South San Francisco (Gateway Blvd)

USA - California - Santa Rosa

USA - California - San Francisco

USA - California - Oakland

USA - California - Palo Alto

USA - California - California

time type

Full time

job requisition id

R392662

Job Description:

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.

Responsibilities

Analytical Transfer:

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

External Analytical:

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 reso