Senior Manager, Analytical Development and Quality Control
Department: 110 CMCLocation: Waltham, MA
Company Overview:
Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE™ platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
Dyne is seeking a Senior Manager, Analytical Development and Quality Control. The Senior Manager, Analytical Development and Quality Control, will support and oversee analytical technology transfer and validation; be responsible for 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, including 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; and 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
- Performing and designing 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
- Support the development and expansion of the internal Analytical Development/Chemistry, Manufacturing, and Control (CMC) lab
- Up to 30% travel domestically (15%) and internationally (15%)
Education & Experience Requirements
- Bachelor’s (or higher) or equivalent in Biology, Biochemistry, Chemistry, Pharmaceutical Sciences, or closely related
- 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)
- Managing QC external vendors
- 2 years authoring regulatory filings and defending queries
Other Requirements:
- 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
- Performing and designing in-use compatibility studies to facilitate clinical drug preparation and dosing
- Must work onsite full time
#LI-Onsite
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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