Director, Quality Control

Editas Medicine•Cambridge, MA

4d•$215,000 - $235,000

About The Position

The Quality team is seeking a highly motivated and experienced technical and organizational leader in gRNA, mRNA, and Lipid Nanoparticle (LNP) analytical methodologies and GMP testing. The successful candidate will collaborate with a high-performing CMC team, coordinating with process and analytical experts cross-functionally in Research and Discovery, Process Development, Analytical Sciences, Manufacturing, and Quality Assurance, to transfer, qualify and oversee in-process and release testing to advance Editas’ in vivo gene medicine portfolio. The individual will also be a key contributor to the overall program CMC strategy. This role requires strong analytical expertise, GMP experience, as well as a passion to lead, mentor and influence people.

Requirements

Degree in Microbiology, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or related discipline with 8+ (Ph.D.), 10+ (M.S.), 12+ (B.S.) years of relevant experience in drug development.
Strong technical expertise and hands-on experience with analytical test method optimization, validation, and transfers as well as CTO/CMO management are required.
Ability to apply Quality-by-Design (QbD) principles to process development strategy planning and execution is required.
Exceptional leadership and interpersonal skills as well as excellent presentation and scientific/technical writing skills is a must.
Strong organizational skills, and ability to multi-task, problem-solve, and adjust priorities to meet goals in a fast-paced environment.
Experience in leading cross-functional collaborations with other internal departments as well as external CDMOs.
Understanding related industry guidance’s (FDA, PDA, ICH and BPOG), knowledge of FDA, EMA and ICH regulations, and understanding of product development life cycle.

Nice To Haves

In-depth expertise in critical raw material, drug substance, and drug product characterization methods and specifications are highly desirable.
Ability to develop analytical control strategies that are phase-appropriate (i.e., phase 1 vs. phase 3 requirements) and grounded in principles of risk management.

Responsibilities

Lead phase appropriate CMC analytical development, qualification/validation, transfer and optimization through strong collaboration with key stakeholders and external partners.
Drive the analytical control strategy for in vivo medicines towards IND/CTA and clinical manufacturing.
Ensure seamless transition of analytics from Analytical Sciences and into GMP manufacturing.
Collaborate with QA to generate, review and approve documentation, including: SOPs, change controls, deviations, CAPAs and OOS/OOT investigation reports.
Act as the lead Subject Matter Expert for gRNA, mRNA, and drug delivery (e.g., LNP) control strategy to direct the.
Establish phase-appropriate specifications based on sound scientific rationale for critical starting materials (e.g. pDNA), drug substance (e.g. gRNA and mRNA), excipients (e.g. lipids and targeting moieties), and drug product (e.g. LNP).
Oversee the external GMP testing of critical starting materials, novel excipients, drug substance and drug product for clinical use.
Implement stability programs to establish the retest dates/shelf life of critical starting materials, novel excipients, drug substance and drug product for clinical use.
Lead cross-functional projects/working teams, champion new ideas/business process improvements to advance company’s in vivo pipeline and technology platforms.
Author and review of regulatory submissions, technical reports, SOPs and work instructions.
Stay up to date with the latest industry trends and product knowledge.
Work cross-functionally (e.g. with Research, Business Development and Legal) to evaluate novel manufacturing technologies and new business partners.