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Senior Manager, External Manufacturing Operations
Job Description
We are looking for a Senior Manager of External Manufacturing Operations to lead the management, implementation, and execution of our CMC strategy at CDMOs. If you are a highly motivated and experienced GMP manufacturing professional with a passion for developing and commercializing innovative drug therapies, we encourage you to apply for this exciting opportunity to join our team.
KEY RESPONSIBILITIES
- Manage operational and technical support of small molecule CDMOs to deliver on late phase clinical and commercial production.
- Lead CDMOs to implement CMC strategy in manufacturing including but not limited to efforts to optimize manufacturing processes, implement process changes, and reduce manufacturing costs.
- Provide on-site CDMO oversight, as needed, to accomplish clinical and routine, commercial production goals
- Provide SME impact assessments on deviation investigations, support CAPAs, and manage proactive initiatives and change controls, as required.
- Lead review and approval for technical reports, risk assessments, batch records, SOP’s, etc. required for cGMP manufacturing.
- Develop, track, and monitor production data for CMO during clinical manufacturing and PPQ to mature to continued process verification (CPV) during commercial manufacturing.
- Represent External MFG / MSAT on cross functional teams (internal and external) for late stage / commercial CDMO. Act as the internal project team lead for CDMO.
- Ensure operational robustness and efficiency through management and tracking of manufacturing metrics and KPIs
- Support authoring and review of CMC sections of health authority submissions. Provide immediate response support, as required
- Develop and maintain strong relationships with internal stakeholders and external partners and ensure strong collaboration and productivity to deliver successful late phase, scale-up cGMP clinical and commercial batches
- Other duties as assigned.
QUALIFICATIONS AND EDUCATION
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- B.S, M.S, or Ph.D. degree in chemistry, chemical engineering or related, scientific discipline required.
- 10+ years of experience w/ a B.S.; 7+ years of experience w/ M.S. or higher.
- 5+ years of experience, in process chemistry/development, MS&T, and/or External Manufacturing for small molecules required.
- cGMP manufacturing experience required. 3+ years preferred.
- Experience managing production at CDMOs required. 3+ years preferred.
- Experience with late-stage clinical enabling, PPQ and commercialization activities for small molecules preferred
REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES
- Experience managing manufacturing activities and CDMOs during clinical/commercial cGMP manufacturing.
- Strong understanding of cGMP regulations and process chemistry.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external partners.
- Experience authoring and reviewing protocols and reports that support GMP manufacturing, validation, and regulatory (BLA/MAA/etc) filings.
- Strong analytical and problem-solving skills, with the ability to apply scientific and engineering principles to complex technical problems and data trending.
- Ability to meet deadlines, adapt to rapid changes, and work in a fast-paced team environment.
- Proficient use of MS Office products, JMP or other data analysis software proficiency is a plus
- Travel required up to 20%
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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