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 markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
- Manage, train, develop, and supervise up to 5 Engineers and/or Packaging Manufacturing or Development Project managers
- Plan and manage automation projects for commercial pharmaceutical packaging lines
- Plan and manage development and installation of packaging inspection equipment and serialization equipment
- Plan and manage development and installation of remote monitoring and cloud SPC data collection
- Conduct validation of packaging equipment, packaging validation, packaging development, selection of sampling plans for packaging testing, in process controls and automated inspection lines
- Support and manage process validation activities from a planning and technical perspective
- Support packaging design, design lifecycle and design activities while coordinating efforts with the Medical Device development organization
- Require the use of methods and manufacturing problem solving techniques such as root cause analysis and data review
- Maintain up to date, proficient knowledge of medical device and pharmaceutical industry standards including ISO9000, 13485, 21 CFR Part 820, 211, 11, packaging standards such as TC 122, ICS 55.020, 11607, 15378, and relevant ICH guidelines
- Oversee and manage production site metrics, including implementing Six Sigma programs, Sampling Plans, Lean initiatives, and process optimizations as applicable
- Maintain an up to date training and documentation record, file all documents and timecards accurately and on-time and ensure the same of the team
- Bachelor’s Degree in an Engineering or Life Science discipline or equivalent. Advanced degree preferred, MBA, PMP certification, Lean / 6 Sigma training all strong assets to this position.
- 7+ years industrial experience in a manufacturing operation. Background with process validation, equipment installation qualification, and manufacturing quality systems (ISO, QSR, GMP, ICH, and FDA regulations).
- Good working knowledge of statistics, sampling plans, and statistical process control. Ability to manage projects and timelines as well as external vendors, contractors, and partners.
We offer a competitive compensation and benefits package including stock incentives, 401k with company match, as well as the expected health and welfare benefits.
Comprehensive relocation benefits are available, as required.
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 recruitment agencies:
Regeneron is using the agency management company, Candex - www.candex.com. 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 without a valid written
search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means.
Regeneron is an equal opportunity employer and is an affirmative action employer.
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