Director of Product Development
6 days ago
Job Summary
Frontage Laboratories is seeking a highly experienced and skilled Director of Product Development to lead our CMC Business Unit. As a key member of our leadership team, you will be responsible for all aspects of formulation development for IND, NDA, 505b(2), and ANDAs. You will also be responsible for collaborating with various stakeholders to develop a plan to offer development and manufacturing services for biologics.
Key Responsibilities
- Participate in new client calls and present formulation capabilities.
- Coach, mentor, and guide the scientists for formulation and process development, scale up, and technology transfer.
- Execute projects to meet timelines for client's regulatory submissions such as IND, NDA, and ANDA filings.
- Review and approve project plans for all dosage forms including manufacturing batch records and product development reports.
- Provide technical guidance to troubleshoot issues in formulation development and manufacturing.
- Identify new equipment and capabilities, prepare justification, collaborate with manufacturing and procurement to prepare Capex documents.
- Ensure teams comply with all relevant cGMP, GLP, DEA, and OHSA regulations.
- Work closely with the Business Development team on new client acquisition, review of contracts and scheduling client visits.
- Develop and maintain excellent working relationships with clients.
- Present webinars, and research at scientific conferences.
Requirements
- Ph.D. in pharmaceutical sciences, or related field with 10+ years of relevant experience in pharmaceutical development.
- Experience in product development and manufacturing of IND, NDA and ANDA products.
- Excellent oral and written communication skills as well as strong focus and attention to details.
- Experience in sterile product development is a must.
- Experience in large molecules is highly preferred.
- Prior experience of working at a CDMO is highly desirable.
- 5+ years of people management experience.
- Strong knowledge of cGMP regulations and working knowledge of US and EU sterile standards.
- Strong organizational and time management skills.
- Ability to work well in a team environment, eager, adaptable.
- Ability to multi-task and shift priorities.
- Demonstrated scientific creativity and technical proficiency.
- Independent and self-starting.
What We Offer
Frontage Laboratories is an equal opportunity employer. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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