Associate Director, Analytical Development, Clinical Quality Control

Disc Medicine

Manage quality activities for biologics programs in clinical development ensuring compliance with ICH and GMP guidelines. Oversee method validation, method transfers, and specifications for clinical development.

Posted 5/15/2026full-timeWatertown • Massachusetts • 🇺🇸 United StatesSenior💰 $158,000 - $193,000 per yearWebsite

About the role

Key responsibilities & impact

Manage quality activities for biologics programs in clinical development, ensuring compliance with ICH and GMP guidelines.
Method validation and method transfers to and from CDMOs.
Lead and or participate in specification setting activities for early and late-stage biologics programs.
Manage method life cycle.
Author, review, and approve method transfer protocols and reports.
Author, review, and approve method validation protocols and reports.
Author, revise, and approve governing SOPs, protocols, reports and memos.
Manage Quality System records for QC activities.
Support GMP audits and inspections.
Act as the team leader to ensure alignment and effective communication among cross-functional areas.
Design and improve processes to ensure compliance with global regulatory requirements.
Support the budget planning and resource allocation to support laboratory operations and staffing.

Requirements

What you’ll need

A B.S. degree is required; an advanced degree (e.g., M.S./Ph.D.) in a related field is preferred.
At least 10-12 years of experience in the biopharmaceutical industry, including prior leadership experience in quality control functions.
Experience with a track record of method validation, method transfer, and hands-on management of day-to-day testing operations for outsourced biologics therapeutics.
Knowledge of statistics and statistical tools (GraphPad Prism, JMP) to assist in trending and or specification setting
Knowledge of Quality processes such as change control, CAPAs, and deviations
Experience and knowledge with Root Cause Analysis tools for OOS investigations is a plus.
Experience conducting QC OOS investigations and write-ups in conjunction with CDMOs.
Experience with Veeva, LIMS and Smartsheet desirable.
Knowledge of bioanalytical and analytical methods, including but not limited to LC-MS, GC-MS, UV-vis, IR/FT-IR, HPLC (SEC, icIEF), CE-SDS, ELISA, cell-based potency assays.
Working knowledge of quality systems, global regulatory requirements (example: 21 CRF Part 11/210/211,820), and Guidance documents.
Knowledge of technical writing for CMC sections of regulatory documents (IND, MAAs)
Exceptional organizational, interpersonal, and communication skills, both verbal and written, with the ability to facilitate meetings, conduct training, and to present information in an advisory capacity.
Attention to detail, excellent review skills, and the ability to organize and manage multiple tasks in a fast-paced environment.
Able to travel up to 25%.
Ability to work both independently and collaboratively with project teams and cross-functionally, to build productive relationships with internal and external partners, to influence decision-making, and to engage in conflict resolution.

Benefits

Comp & perks

Comprehensive benefits
Competitive compensation packages
Flexible work environment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

method validationmethod transferquality controlstatistical toolsRoot Cause Analysisbioanalytical methodsanalytical methodstechnical writingGMP compliancequality systems

Soft Skills

organizational skillsinterpersonal skillscommunication skillsattention to detailreview skillsability to manage multiple tasksindependent workcollaborative workinfluence decision-makingconflict resolution