Role: The position will be responsible for developing and maintaining phase appropriate quality systems, quality operations related to oversight of the manufacture cGMP supply of antibody drug conjugates and intermediates, as well as applicable GCP and GLP study sites. Depending on the product phase, the Director provides both guidance and active development and management of quality systems in Phase 1 through BLA in preparation for commercial production. This will include development of quality systems covering, but not limited to, coordinating external audits and vendor assurance with contract development and manufacturing organizations (CDMOs), contract test labs (CTLs) and other external suppliers. In addition to this external oversight, this position will require the routine management of GXP quality systems internally.
- Develops QA function and actively manages GMP oversight of API and drug products produced at contract manufacturing sites
- Develops applicable QA functions and actively manages GCP and GLP oversight both clinical and nonclinical study sites.
- Ensures Phase appropriate compliance with quality systems, quality procedures, and quality policies
- Develops, implements, and maintains programs/processes in compliance with cGMP
- Responsibilities include the final release of cGMP intermediates, conjugated drug substance, drug product, and for all intended markets
- Responsible for Dyne Inspection Readiness of all internal sites and external vendors
- Represents company as host of regulatory inspections at applicable contract sites and supports inspections at CMO facilities
- Works with Process Development and Manufacturing during technology transfer of new and existing processes to CMOs
- Works with appropriate team members to develop processes to support Dyne’s nonclinical safety (GLP) program
- Works with appropriate team members to develop processes to support Dyne’s clinical (GCP) program
- Develops and implements a QA departmental budget
- Directs all GXP compliance audits as required
- Oversight and validation of electronic systems used for GXP or regulatory submissions
- Reviews, approves, and directs implementation of changes to controlled documents and processes
- A minimum of 15 years in biopharmaceutical QA management. Degree in biology, biochemistry, chemistry or similar preferred
- Proven experience in QA processes and systems to support biopharmaceutical development
- Experience work with external vendors required. Experience with bioconjugates or multiple intermediates preferred
- Experience in leading the Quality function for a biopharmaceutical company and familiarity with GxPs
- Experience with implementing and managing QA documentation systems
- Experience with GDPR and acting as company Data Protection Officer (DPO) desirable
- Excellent interpersonal, organizational, negotiations and communication skills
- Effective team member than can work collaboratively across all functions
- Demonstrates strong organizational skills, including the ability to prioritize workload
- Ability to work well in a deadline-driven environment and capable of supporting multiple programs
- Results oriented: Establishes clear expectations and priorities, sets objectives and effectively applies resources. Sets clear goals and consistently delivers. Flexible and creative problem-solving skills.
- Strategic Thinking: Can see the big picture, able to constantly think ahead about ways to do things better. Thinks logically, develops and evaluates options, identifies pros and cons. Able to challenge current processes, practices and strategy and uncover alternative approaches, solutions or methods.
- Communications: 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.
- Self-directed: Individual who is able to work effectively with limited direction in a complex, fast-paced environment.
- Waltham, MA, United States
- Employment Type
- Full Time
- Job Location
- On Site
- Valid Through
- 31 Jul 2020
- Posted On
- 10 Jul 2020
Dyne Therapeutics is pioneering life-transforming therapies for patients with serious muscle diseases. The company’s FORCE™ platform delivers oligonucleotides and other molecules to skeletal, cardiac and smooth muscle with unprecedented precision to restore muscle health. Dyne is advancing treatments for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Dyne was founded by Atlas Venture and is headquartered in Waltham, Mass.