Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on Twitter, LinkedIn and Facebook.
The position will support and oversee analytical technology transfer and validation, and overall management of CMC activities related to external QC testing/release and stability of antibody drug conjugates and intermediates. The Manager will also contribute to management of analytical development and QC activities in Phase 1 thru 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.
This role will work closely with key stakeholders within CMC as well as across company including 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 remote role.
Primary Responsibilities 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
- 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 CAPAs are initiated, addressed, and closed within target timeframes
- Author, review analytical method validation protocols and reports, OOS/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 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
Education and Skills Requirements:
- A minimum of 3-5 years in Analytical Development or QC or Research & Development
- 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
- Knowledge of a variety of analytical techniques including SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, and mass spectroscopy.
- Proven experience in processes and systems to support analytical development and QC activities
- Experience with managing QC external vendors required
- Strong knowledge of biologics and small molecules analytical development, quality control, and QA compliance of analytical methods required
- Experience authoring and supporting regulatory filings and provide technical support for responses to regulatory bodies is desirable
- 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
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.