Principal Lead External Manufacturing
vor 5 Monaten
Janssen Research & Development, L.L.C., a division of Johnson & Johnson’s Family of Companies is recruiting for a Principal Lead External Manufacturing located in Schaffhausen, Switzerland. _
The Principal Lead External Manufacturing (Manufacturing Science & Technology) will establish Manufacturing Science and Technology expertise across different equipment platforms for drug product development & manufacturing with a focus on Parenterals. You will represent the DPDS in development and clinical/commercial supply teams ensuring timely clinical supplies for drug products.
**Key Responsibilities**:
- Ensure timely readiness of contract manufacturing organizations (CMO) to support clinical activities.
- Ensure timely delivery of clinical material from CMO.
- Manage the overall relationship with CMOs and act as the single point of contact between the organization and the respective manufacturing site.
- Provide input and requirements to drug product development and primary container development teams.
- Support scale-up and technology transfer.
- Source raw materials and components and act as point of contact for material and supplier-related issues at CMO.
- Ensures that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations.
- Support investigations, CAPAs, change controls according to assigned responsibilities and perform critical raw data review for key documents.
- Prepare business plan forecasts and monitor actual spending versus budget.
**Qualifications**:
**Qualifications**:
**Education**:
- PhD in Pharmaceutical, Biochemical, Chemical, Life Sciences or a related field with 4+ years of experience OR Master's degree with 7+ years of experience OR Bachelor's degree with 9+ years of experience is required.
**Experience and Skills**:
**Required**:
- Demonstrated proficiency and experience in biopharmaceutical process design is required.
- Understanding and experience in fill/finish operations is required.
- Experience in clinical or commercial manufacturing is required.
- Motivated with the ability to work independently and manage direct reports with demonstrated problem solving skills is required.
- Ability to collaborate with cross-functional teams is required.
- Prior experience working with a CMO is required.
- Excellent oral and written language skills are required.
**Preferred**:
- Proven proficiency and experience in biologics drug product development within the biopharmaceutical industry is preferred.
- Solid understanding and experience in technology transfer operations is highly preferred.
- Proven track record of creativity and problem solving skills highly preferred.
**Other**:
- Travels: 10 - 20%
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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