Senior Director, Technical Development & Manufacturing
Position Summary
The Senior Director Technical Development & Manufacturing is accountable for building and leading a technical team of development scientists and manufacturing product stewards for small and large molecule clinical and commercial products. The lead and Technical Development and Manufacturing team will partner with the External Manufacturing process engineers, Quality, and CMC RA to ensure robust technical strategies throughout the lifecycle of the product. Accountabilities include early mid and late phase product development and commercial manufacturing support. They will develop a culture within the team supporting innovation and continuous improvement.
Roles and Responsibilities:
- Lead both biological and chemical process development teams to perform the end-to-end process development activities, including upstream, downstream, and drug product development
- Provide technical strategies to implement stage-appropriate process improvement and optimization for drug substance and drug product manufacturing.
- As a key leader within the wider Technical Operations and Amicus Organization, contribute to ongoing continuous improvement initiatives in the area of process, system, and cultural development
- Support the preparation of CMC content for IND, IMPD, NDA, MAA, and BLA submissions and correspondences
- Collaborate with External Manufacturing, CMC RA, Quality, and Analytical Development via cross functional matrix teams
- Single point of technical accountability for a product throughout the lifecycle
- Accountable for development, 2nd gen processes, and lifecycle management of process control strategies
- A subject matter expert regarding manufacturing processes, CMC Quality by Design deliverables, and use of lean sigma tools
- Provides technical input into process monitoring, ensuring product history and process knowledge are maintained and leveraged in process reviews and regulatory submissions as appropriate
- Manages team members and fosters an environment of performance with a sense of urgency to meet our patients needs
- Develops team members and supports their growth and career ambitions
- Member of the CMC Leadership Team and reports to VP, CMC
Educational Requirements:
- A MSc/PhD in Chemical/Biochemical Engineering or Biological Sciences or related disciplines
Professional Work Experience Requirements:
- 10+ years of industrial experience in CMC, process development for drug substance and/or drug product manufacturing
- Experience in a molecule steward role/product owner role
- Experience working in an external development business model in collaboration with strategic CDMO partners
Experience and Skills:
- Experience with early and late phase CMC development, license registration and lifecycle management
- Broad knowledge of bulk biologics analysis, upstream and/or downstream processing, drug substance and drug product formulation, process characterization, scale-up and manufacturing in cGMP environment, with proven expertise and experience in several of these fields
- Ability to oversee small and large molecule programs
- Experience in IND/BLA filings including drafting, reviewing, approving, and supporting regulatory filings and responses
- Ability to manage and partner across multiple geographies.
- Solutions oriented, strategic thinker with strong problem-solving skills and an ability to work with internal stakeholders at all levels
- Autonomy, self-motivation, and efficiency, with an appropriate sense of urgency in a fast – paced and dynamic environment whilst working at times with ambiguity.
- Strong verbal and written skills with ability to explain complex, challenging issues in a clear manner to all levels of the organization
Other skills/Attributes:
- Demonstrated alignment with Amicus Mission Focus Behaviors
- Passion for rare disease and patient focused
- Good team player
Location:
- Preferred location is Princeton, NJ , Marlow, UK, Dublin, Ireland(with a hybrid work approach)
Travel:
- It is expected that any remote workers are able to travel to the office up to 10% of the time
- Up to 10% travel to CDMO partners
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.
Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.