Associate Director/Director Technical Development & Manufacturing, Contractor

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.

Position Summary

The Associate Director/Director Technical Development & Manufacturing ensures robust, scalable, and cost-effective processes for the manufacture of clinical and commercial large molecule products. This individual will collaborate with Analytical Development, External Manufacturing process engineers, Science Discovery, Quality, and CMC Regulatory to lead and support various aspects of process development, control strategy development, tech transfer and GMP manufacturing. The individual will work closely with our CDMO partners and external vendors to execute project deliverables.

Roles and Responsibilities

1.Leads bench scale and pilot scale process development and control strategy development for large molecule drug substance with focus on upstream cell culture process

2.Leads and/or supports process tech transfer, facility fit and manufacturing readiness

3.Performs process and operational risk assessments and uses QbD principles for control strategy development

4.Directs work at CDMO and works in partnership with CDMO stakeholders to meet project goals

5.Collaborates with internal project team members such as Analytical Development, External Manufacturing, Quality, and CMC Regulatory to execute on project deliverables

6.Performs data analysis and provides summary presentations at team and management meetings to aid in technical decision making

7.Authors and reviews technical documentation such as process descriptions, process characterization protocols/ reports, tech transfer protocols, etc.

8.Provides support for manufacturing troubleshooting and root cause investigations

9.Fosters an inclusive workplace, encourages innovation, advocates a quality culture and inspires performance with a sense of urgency to meet patients’ needs

Requirements

Educational Requirements

•A BS/MS/PhD in Chemical/Biochemical Engineering, Biotechnology, Biochemistry, Biological Sciences or related disciplines

Professional Work Experience Requirements

•8-12 years industry experience in process development and/or MSAT roles

•Subject matter expertise in upstream cell culture unit operations

•Experience working in an external development business model in collaboration with strategic CDMO partners

Experience and Skills

•Experience with process development, process characterization, and control strategy development

•Experience with perfusion process development and scale-up is desirable

•Comprehensive knowledge of drug substance unit operations and factors impacting productivity and product quality

•Comprehensive knowledge of QbD/DoE principles and FMEA risk assessments

•Experience with scale-up, tech transfer and/or manufacturing in cGMP environment is preferred

•Ability to oversee technical work packages with minimal supervision

•Experience with data analysis, hypothesis driven root cause analysis, making technical presentations and technical documentation authoring and review

•Demonstrated ability to partner with internal and external stakeholders, across multiple geographies

•Solutions oriented, strategic thinker with strong problem-solving skills

•Leads with 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 interpersonal, verbal and written communication skills

•Ability to foster a collaborative work environment

Other skills/Attributes

•Demonstrated alignment with Amicus Mission Focus Behaviors

•Passion for rare disease and patient focused

•Good team player

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.

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