Senior Manager, Analytical Development and Quality Control

Senior Manager, Analytical Development and Quality Control, for Dyne Therapeutics, Inc., in Waltham, MA (100% onsite role). Support and oversee analytical technology transfer and validation, and overall management of Chemistry, Manufacturing, and Control (CMC) activities related to external quality control (QC) testing/release and stability of antibody drug conjugates and intermediates. Contribute to management of analytical development and QC activities in Phase 1 through BLA and commercial production. This includes coordinating external activities related to analytical method development and QC activities with contract development and manufacturing organizations (CDMOs), contract test labs (CTLs) and other external suppliers. Effectively manage Dyne’s complex clinical supply chain and support eventual launch and commercialization efforts. The specific duties include: responsible for aspects of analytical and QC of intermediates, drug substance, and drug product including analytical development, validation, characterization, tech transfer, analytical method qualification, release, and stability testing; assist with developing the analytical/QC strategy for complex biologics/bioconjugates guided by ICH frameworks: perform and design in-use compatibility studies to facilitate clinical drug preparation and dosing; partner to identify and direct external cGMP laboratories conducting raw materials, intermediate and DS/DP product testing; work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and corrective and preventive actions (CAPAs) are initiated, addressed, and closed within target timeframes; author and review analytical method validation protocols and reports, out of specification (OOS)/out of trend (OOT) investigations, stability protocols and reports, change controls, risk assessments and product specifications; review and approve analytical data for batch release and stability trending; manage external CMOs and CTLs for the transfer and validation of analytical methods product characterization testing and product release/stability testing; support establishment of critical quality attributes, specifications, and trend stability data to establish expiry dating of drug substance and drug product (DS and DP); help define product analytical validation approaches; partner with QA to provide oversight of cGMP QC-related activities and documents (change controls, deviations, CAPAs, procedures, QC raw data review, batch release support, stability protocols and programs, validation protocols, etc.); oversee Reference Standard program including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories as appropriate; work closely with R&D to support analytical development activities and enhance the tech transfer process; support the development of regulatory CMC documentation and partner due diligence: serve as primary author on analytically focused regulatory documentation and query responses; and support the development and expansion of the internal Analytical Development/Chemistry, Manufacturing, and Control (CMC) lab. Requirements: Bachelor’s (or higher) Degree or equivalent in Biology, Biochemistry, Chemistry, Pharmaceutical Sciences, or closely related and 2 years in Analytical Development or Quality Control (QC) or Research and Development, including using general, compendial and product-specific analytical tools and practices pertinent to monoclonal antibodies, small molecules, oligonucleotides, and their mab-conjugates (ADCs, AOCs) and managing QC external vendors, and 2 years authoring regulatory filings and defending queries. Must also have demonstrated proficiency in: processes and systems to support analytical development and QC activities; biologics and small molecules analytical development, quality control, and QA compliance of analytical methods; and performing and designing in-use compatibility studies to facilitate clinical drug preparation and dosing. Up to 30% travel domestically (15%) and internationally (15%). Resumes to: Ashley Clark, Director, HR, Job Code SVB-SMAD, Dyne Therapeutics, Inc., 1560 Trapelo Rd, Waltham, MA 02451.