Manager, Quality Control

Company: Mersana Therapeutics
Location: Cambridge
Posted on: June 24, 2022

Job Description:

In this role you'll bring your QC technical and leadership experience to design and execute on the Quality Control strategy for Mersana's ADC programs. You'll form close partnerships with our development, clinical and operations teams. To be successful, you'll utilize your strong communication and relationship building skills as you manage testing and stability deliverables through external services. This position reports to the Director of Quality Control. How do you know if you're the right fit? You'll be capable of taking an active role in supporting new drug candidates by leading the analytical development strategies for Mersana's ADC programs. Your responsibilities will include:

• Working with the Analytical team in methodologies to support testing of small molecule, monoclonal Antibody, drug substances and products.
• Working closely with collaboration Partners to ensure project needs are met.
• Identifying and overseeing CTL's/CMO's to ensure stability and product release goals are met.
• Providing analytical support to method transfer, optimization, qualification, and validation at CTLs and CMOs including review and approval of feasibility, qualification/validation protocols and reports.
• Performing QC data review/approval of test/raw data for release and stability analysis.
• Authoring and reviewing controlled GMP documents such as CoA/CoTs, analytical methods and associated qualification/validation protocols, reports, specifications, change controls, deviation, investigations, etc.
• Establishing a robust Stability program strategy in support of Mersana early and later-stage programs. Managing data trending to support stability data assessments and establishment of product shelf-life.
• Overseeing Reference Standard program including review and approval of qualification protocols/reports, characterization and comparability reports performed internally or at CMOs and CTLs.
• Authoring and reviewing relevant sections of Regulatory Submissions for INDs, IMPD, BLAs, etc. and prepare responses to health authority inquiries and observations.
• Participating and representing QC function in various cross-functional teams both internally and externally. Presenting data and providing updates of action items, and meeting minutes.
• Conducting audits and inspection activities to ensure compliance with regulations. The other stuff This role is typically best suited for Bachelors' or Masters' level candidates with 8+ years of experience in analytical chemistry with a focus on biologics and complex products preferably in the CMC area. Additionally, successful candidates will possess:
  • Extensive experience in analytical CMC and leading cross-functional teams and Projects.
  • Experience interacting with and managing external resources (CTO's/CMO's).
  • Ability to exert influence diplomatically and have a positive impact inside and outside of the organization.
  • Demonstrated interpersonal, organizational, negotiation and communication skills.
  • Ability to solve problems, develop plans and advance to completion on time and in full.
  • Full understanding of scientific principles and applicable GxPs, Quality, and pharmaceutical processes, safety, and data integrity.
  • Prior experience with computer, lab systems and software such as (Excel, Power Point, Word, Share Point, JMP, GraphPad Prism and Veeva QualityDocs/RIM)
  • Ability to travel domestically and internationally as needed. Position is eligible for bonus, option awards and benefits including medical, dental and life insurance, 401(k) participation, vacation and paid holidays. Successful candidate must be authorized to work in the United States. Mersana Therapeutics, Inc. is an equal opportunity employer.

Keywords: Mersana Therapeutics, Cambridge , Manager, Quality Control, Executive , Cambridge, Massachusetts