Disc Medicine
biopharmaceutical
AssociateDirector,AnalyticalDevelopment&ClinicalQualityControl
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“Associate Director, Analytical Development & Clinical Quality Control at Disc Medicine. Skills: method validation, method transfer, clinical development programs, quality control management, biologics programs, ICH and GMP guidelines compliance. manage quality activities for biologics programs in clinical development. ensuring compliance with ICH and GMP guidelines”
Industry & Context.
Root Cause Analysis tools for OOS investigations; QC OOS investigations
Able to travel up to 25%
What They're Looking For.
Must Have
B. S. degree, 10-12 years of experience in the biopharmaceutical industry, prior leadership experience in quality control functions, method validation, method transfer, hands-on management of day-to-day testing operations for outsourced biologics therapeutics, Knowledge of statistics and statistical tools (GraphPad Prism, JMP), Knowledge of Quality processes such as change control, CAPAs, and deviations, Experience conducting QC OOS investigations and write-ups in conjunction with CDMOs, 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, Attention to detail, excellent review skills, ability to organize and manage multiple tasks in a fast-paced environment, Ability to work both independently and collaboratively with project teams and cross-functionally, build productive relationships with internal and external partners, influence decision-making, engage in conflict resolution
Nice to Have
advanced degree (e. g. , M. S. /Ph. D. ) in a related field, Experience with Root Cause Analysis tools for OOS investigations, Experience with Veeva, LIMS and Smartsheet, Ability to facilitate meetings, Ability to conduct training, Ability to present information in an advisory capacity
What You'll Do.
manage quality activities for biologics programs in clinical development
ensuring compliance with ICH and GMP guidelines
method transfers to and from CDMOs
specification setting activities for early and late-stage biologics programs
manage method life cycle
Manage Quality System records for QC activities
and other applicable quality-related investigations and events
Support GMP audits and inspections
Design and improve processes to ensure compliance with global regulatory requirements
Establish and maintain a network of external partners
Support the budget planning and resource allocation
How You'll Work.
Team & Collaboration
Act as the team leader to ensure alignment and effective communication among cross-functional areas, including analytical development, process development, formulation development, manufacturing, supply chain, regulatory, quality assurance, and other internal and external partners; work collaboratively with project teams and cross-functionally; build productive relationships with internal and external partners
Communication Scope
Exceptional organizational, interpersonal, and communication skills, both verbal and written; ability to facilitate meetings; ability to conduct training; ability to present information in an advisory capacity
Process & Methodology
manage method life cycle, organize and manage multiple tasks
Full Job Description
Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. COMPANY OVERVIEW: Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires. POSITION OVERVIEW: The Associate Director of Quality Control will manage quality activities for biologics programs in clinical development, ensuring compliance with ICH and GMP guidelines. The primary functions include method validation and method transfers to and from CDMOs. Additionally, this role will lead and or participate in specification setting activities for early and late-stage biologics programs as well as manage method life cycle. Significant contributions from this role will be essential for facilitating regulatory filings of Disc Medicine assets. This position reports to the Director of Analytical Development and Clinical Quality Control within the Technical Operations organization at Disc Medicine. The ideal candidate should have 10-12 years of experience in quality control management in the pharmaceutical or biotech industry. RESPONSIBILITIES: This role will have extensive technical expertise and be responsible for method validation and method transfer for Disc Medicine’s clinical development programs. The technical responsibilities include: Author, review, and approve method transfer protocols and reports from transferring and receiving CDMOs per regulatory requirements. Author, review, and approve method v
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