Manager, Operations, Pharma
- San Clemente, CA
The Manager, Pilot Pharma Operations, based in San Clemente, CA will provide technical, operational and strategic leadership to define and manage new processes and systems in order to achieve Pharmaceutical Development objectives.
• Lead the Pilot Pharma function (upstream and downstream) to demonstrate scalable production platforms
• Support multi-product portfolio of clinical development programs.
• Lead Pilot Plant operations to demonstrate robust production processes across multiple platforms to effectively de-risk process technology transfer to manufacturing partners (Internal or External)
• Provide leadership to build and refine business processes and systems necessary to increase and enhance operational efficiency and “right first time” success.
• Build and refine equipment, capabilities, and systems while defining personnel structure required to run parallel pilot campaigns in support of process and product development and transfer.
• Collaborate closely with other internal Pharmaceutical Development teams including Analytical Development, Process Development, and CMC groups to ensure efficient development.
• Provide representation on CMC team in support of regulatory activities, including registration filings.
• Represent Operations at internal cross-functional program and CMC strategy meetings, as well as external manufacturing organizations, provide subject matter expertise and enhance partnerships.
• Assist in the leading of sections of CMC Section-related documentation by compiling/assembling appropriate data for submissions to FDA and other regulatory authorities
• Must have strong technical understanding of upstream and downstream manufacturing processes and applicable unit operations.
• Must have extensive technology transfer experience.
• Must have background knowledge of cGMPs, ICH guidelines and knowledge of CMC regulations for new drug submissions, both domestic and international.
• Experience with formulation and analytical method development is desired.
• Prior experience working with virtual CRO/CMO/CPO's is desired.
• Must be flexible, able to multitask across activities, a strong team player, he/she should have excellent interpersonal skills to harmoniously interact with other employees and development functions.
• Initiative and persistence to drive the completion of open items to meet timelines.
• Must be strongly committed to achieving a quality work product with an unwavering adherence to cGMPs, compliance and other quality requirements
• 8+ years of relevant experience working in Process Development in the Pharmaceutical/ Biotech industry
• Previous experience in Pharma, Biologics, vaccines, or gene therapy manufacturing operations is preferred.
• In-depth technical understanding of early and late-stage process development, scale-up, and process validation to support GMP manufacturing
• Late stage / commercial experience development or manufacturing experience preferred
• Proven leadership experience and people management skills with the desire and ability to work in a fast-paced, start-up environment
• Strong collaboration and team-building, communication, and organizational skills required
• Excellent written and verbal communication skills
• BS/MS or PhD in a scientific field of study
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
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