Manager, Quality Control

Role Summary:

The Manager, Quality Control will support and oversee stability programs as well as QC testing and release of antibody drug conjugates and intermediates. This role will also contribute to the management of analytical development and QC activities in Phase 1 through BLA and commercial production. These activities include coordinating QC efforts and support of analytical activities with contract development and manufacturing organizations (CDMOs), contract test labs (CTLs), and other external suppliers.

This role will work closely with stakeholders within CMC and cross-functionally with Development, R&D, Regulatory, and Project Management on QC related activities to effectively manage Dyne’s complex clinical supply chain and support eventual launch and commercialization efforts.

This role is based in Waltham, MA without the possibility of being a fully remote role.
 
Primary Responsibilities Include:

• Support aspects of developmental and GMP Stability management for intermediates, drug substances and drug products for all Dyne programs at CMOs and CROs
• Support aspects of quality systems including OOS/OOT investigations, quality investigation records, change controls, deviations, CAPAs, etc.
• Collaborate in the oversight of stability studies to external vendors for preclinical and Phase I – III CMC activities
• Coordinate stability pulls, manage sample shipments with help of logistics to and from storage and testing sites, monitor and review data received from external sites
• Support tracking and trending of stability tables of data for intermediates, drug substance and drug product
• Conduct raw data review of vendor generated QC reports as needed
• Assist in the oversight of reference standard program including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories as appropriate
• Participate in the development and revision of product specifications; provide scientific input and statistical analysis of results
• Contribute to cross-functional laboratory investigations related to stability and laboratory operations as needed
• Contribute to the drafting/revision of QC and CMC sections of regulatory submissions as needed
• Participate in preparation of responses to regulatory agency questions
• Support testing in the lab as needed (10-15%)

Education and Skills Requirements:

• A minimum of4-6 years’ experience in GMP QC testing and/or QC stability management
• Degree in biology, biochemistry, chemistry, or similar related field required
• Strong quality and analytical background with experience in general, compendial and product-specific analytical tools and practices pertinent to monoclonal antibodies, small molecules, and their Mab-conjugates
• Experience with managing QC external vendors preferred.
• Working knowledge of a variety of analytical techniques including SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, GC, and mass spectroscopy
• Strong knowledge of cGMP/ICH/FDA/EU regulations a plus.
• Experience and knowledge of data analysis and trending software (SLIMStat) is highly desirable.
• Well versed with biologics and small molecules quality control and QA compliance of analytical methods/data
• Team member who can work collaboratively with colleagues across all functions
• Results oriented, establishing clear expectations and priorities, sets objectives and effectively applies resources
• Ability to set clear goals and consistently delivers
• Flexible and creative problem-solving skills
• Logical thinker to develop and evaluates options, identifying pros and cons
• Ability to challenge current processes, practices and strategy and uncover alternative approaches, solutions, or methods
• Excellent communication and interpersonal skills with success in working across organizational boundaries at all levels to bring together people of diverse backgrounds and skill sets to create, influence, and negotiate win-win solutions
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
• Excellent organizational skills

#LI-Onsite