Associate Director, Analytical Development/QC

Dyne Therapeutics

Waltham, MA, US
  • Job Type: Full-Time
  • Function: Research Sci/Assoc/Mgr
  • Post Date: 02/10/2021
  • Website: dyne-tx.com
  • Company Address: 400 Technology Square 10th Floor, Cambridge, MA, 02139

About Dyne Therapeutics

Dyne was founded with a singular focus: to transform the lives of people with serious muscle diseases by pioneering muscle-targeted therapies. Our proprietary technologies provide the foundation for breakthrough treatments. We have assembled a world-class team of experts who are united by their commitment to fulfill this mission.

Job Description

Company Overview:

Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are utilizing our proprietary FORCE™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD).

For more information, please visit www.dyne-tx.com, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

The position will be responsible for analytical development, 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. Depending on the product phase, the Associate Director will provide both guidance and active management of analytical development and QC activities in Phase 1 thru BLA and commercial production. This will include 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. S/he will also have a matrix role for research and development activities related to analytical development.

This management role will report to the VP, CMC and will work closely with key stakeholders including Development, R&D, Clinical, Regulatory Affairs, Project Management, and corporate leadership to define and build the QC capabilities required to effectively manage Dyne’s complex clinical supply chain and support eventual launch and commercialization efforts.

Primary Responsibilities Include:

  • Responsible for all aspects of analytical development and QC of all intermediates, drug substance, and drug product including analytical development, validation, characterization, tech transfer, analytical method qualification, specifications, 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
  • Develop review and approve method transfer/validation protocols
  • Perform data analysis, and generate reports supporting product release and stability programs
  • 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 QA compliance with cGMPs, cGLPs and guidance for clinical trial materials
  • Prepare and review CMC analytically focused documentation for biologic INDs and BLAs and support FDA and EMEA interactions
  • Support the development of regulatory CMC documentation and partner due diligence
  • 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

Education and Skills Requirements:

  • A minimum of 10 years in QC and/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
  • Proven experience in processes and systems to support analytical development and QC activities
  • Experience authoring and supporting regulatory filings and provide technical support for responses to regulatory bodies
  • 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 in all phases of CMC regulatory submissions and interactions regarding CMC issues, ideally including post-approval experience, international experience, and negotiation experience with regulatory authorities
  • 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
  • Ability to think strategically, to see the big picture, to consistently think ahead about ways to do things better
  • 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
  • Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations
  • 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.

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This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.