Regeneron Pharmaceuticals Director, Drug Product Manufacturing Operations in Rensselaer, New York
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
The Director of Drug Product Manufacturing Operations is accountable for clinical and commercial drug product manufacturing operations. This is a leadership role with focus on the start-up and execution of GMP operations for all production areas, ensuring the facility is properly staffed and trained, and supporting a production planning process that is dynamic and flexible to meet the needs of Regeneron’s patients. The Director will also be responsible for implementing a cross-functional site leadership team, serve as a key member of various management teams within Industrial Operations and Product Supply (IOPS) and reports directly to the Executive Director of Drug Product Manufacturing.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Provide leadership, vision, and management to the Drug Product Manufacturing site.
• Lead all aspects of drug product manufacturing operations at the facility to manufacture commercial and clinical parenteral medicines according to approved protocols, regulations, and schedules.
• Guide and oversee validation activities involving DP Manufacturing equipment and processes. Partner with DP Project Management to implement new production processes. Processes may include but not limited to formulation, filling, lyophilization, PFS and auto injector assemblies, and finished product label and carton.
• Manage key manufacturing metrics / site goals, support critical program milestones, and drive continuous improvement initiatives that are essential to meeting patient and business needs.
• Collaborate with Human Resources and other functions to develop a multi-year staffing and recruiting plan for the facility.
• Rapidly and accurately communicate issues to Senior Leadership. Resolve manufacturing and facility issues to mitigate any supply disruptions to our patients.
• Work effectively across IOPS departments, such as Quality Assurance, Facilities, Engineering, DP Project Management, MSAT, Regulatory, Quality Control, IT, and Supply Chain.
• Write, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
• Oversee and approve schedules, production plans, and material requirements.
• Ensure the effective use of material, equipment and personnel in producing quality products.
• Ensure that IOPS safety standards are maintained.
• Prepare and administer expense and capital budgets for the facility. Recommend capital expenditures and aids in the realization of capital projects.
• Oversee, support and participate in cGMP audits of all production areas within the facility.
• Maintain site inspection readiness and represent the manufacturing facility during regulatory and client audits.
• Provide technical input to resolve manufacturing process challenges.
Knowledge, Skills and Abilities:
• Demonstrated manufacturing leader with expert knowledge of parenteral manufacturing, device assembly and finished label and package for both clinical and commercial medicines
• Highly experienced in overseeing manufacturing operations in an aseptic biologics manufacturing environment. Experience with multiproduct biologics facility start-up is desired.
• Working knowledge of industry practices, global regulations and experience interacting with across multiple health authorities (e.g. FDA, EMA, PMDA, etc.). Must have a mindset and ability to drive inspection readiness for the site at all times.
• Deep understanding of aseptic processes, equipment, automation, validation, and cleanrooms and other classified area requirements.
• Proven ability to initiate and lead a site leadership team with cross-functional members as well as direct reports. Excellent at collaborating with key functions (Quality Assurance, Facilities, Supply Chain, Project Management, etc.) and efficient at removing barriers.
• Knowledge of transferring aseptic parenteral filling, device assembly and finish label & pack operations.
• Effective at communicating to a wide audience of experience, skills and expertise. Able to communicate a vision for the IOPS site and report on progress in achieving the vision.
• Excellent at developing staff, teams and future leaders. Leads by example.
• Working knowledge of financial operations in a manufacturing environment.
• A successful candidate will have the ability to think strategically, solve complex challenges while being able to quickly adapt to emerging situations. This individual must enjoy being challenged to think critically, embrace new technologies, and have a passion for continuously improving processes and operations.
Education and Experience:
• Minimum of a Bachelor of Science degree in any of the physical or biological sciences, or chemical engineering.
• 12+ years biopharmaceutical/biotech work in a GMP drug product production facility.
• 5+ years reporting to or interacting closely with Senior Leadership.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
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