Boston, MA (Hybrid)
Position: Drug Product Commercial Manufacturing (Associate Director – Director)
Position Summary
Karuna is seeking an experienced and proactive Associate Director/Director, Drug Product Commercial Manufacturing, with expertise in small molecule process development/manufacturing to support the potential launch and commercial manufacture of our product candidate for the treatment of schizophrenia.
Reporting to the Vice President of Commercial Manufacturing within the CMC & Preclinical Development organization, this leadership position will play a critical role in supporting worldwide commercial drug product manufacturing for solid/liquid oral dosage forms, including continuous improvement activities and operational oversight of external partner manufacturing operations (contracts, supply planning, investigation management, etc.). This is a unique opportunity to work with a well-funded and proven leadership team in a rapidly growing company.
Responsibilities
- Lead, develop, and mentor a group of three experienced process development scientists/engineers within the commercial drug product manufacturing organization.
- Develop and implement robust drug product manufacturing plans at external vendor sites in close collaboration with the Commercial, Supply Chain and API manufacturing teams.
- Manage the on-time and in-full delivery of bulk commercial drug product from Karuna’s external vendor network partners.
- Lead internal efforts to support process troubleshooting and investigative work at manufacturing site(s) in support of Karuna’s commercial (and late-stage development) asset(s).
- Identify, develop business cases for, and implement manufacturing process scale-up and optimization activities when relevant and as per commercial supply/product profile needs.
- Lead Continued Process Verification (CPV) activities at external vendor sites with joint ownership of product technical reviews, statistical analyses of product and process performance, etc.
- Support the Commercial Manufacturing/CMC team in designing Karuna’s future state drug product manufacturing network, including site scoping, business case analysis and final site selection recommendations.
- Work collaboratively with the Formulation Research and Drug Product R&D Formulation groups to influence the rational selection of commercial manufacturing processes (solid and liquid) during early development.
- Design and implement robust technology transfer plans for drug product manufacturing processes in conjunction with the above groups.
- Represent the commercial drug product manufacturing team in meetings/interactions with key stakeholders, including but not limited to Commercial, Supply Chain, Clinical, and internal CMC teams.
- Support all regulatory activities and filings (INDs, IMPDs, NDAs, briefing packages, any other regulatory dossiers), including reviews of, and associated changes to, such documents, for assigned products.
- Collaborate with Quality Assurance and associated line functions to ensure implementation of contemporary quality standards throughout drug product manufacturing.
Required Qualifications
- Ph.D. in pharmaceutics or a related engineering discipline with 8+ years of industry experience, or a Bachelor’s/Master’s degree with 12+ years relevant work experience, in the commercial manufacturing and/or late-stage process development of solid oral dosage forms.
- Prior leadership experience (direct or within a matrixed environment).
- Successful track record in working at, or directly managing and overseeing CDMOs in, a commercial manufacturing environment.
- Strong familiarity with statistical concepts involved in CPV, including process control and optimization performance indicators.
- Experience with standard processing technologies for both immediate and modified release oral dosage forms. Working knowledge of extrusion spheronization is desirable.
- Experience in drafting, reviewing, and approving cGMP documentation.
- Ability to travel to commercial manufacturing sites, approximately 15-25%/year.
- Independent thinker with the ability to drive results in a fast-paced work environment with minimal supervision.
- Excellent verbal and written skills with strong attention to detail and product quality.
- Forward thinking mindset with ability to manage multiple projects and identify and resolve issues.
- Broad experience in an emerging, publicly traded company environment is a plus.
The successful candidate will also embody our values:
Our purpose is to create value for those we have the privilege to serve:
- We take pride in our work
- We keep our promises and deliver
- We are driven to meaningfully innovate
- We succeed through inclusion and teamwork
Karuna Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
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