As the Manager for Drug Product Manufacturing Sciences and Technology you would lead a team responsible for the development of robust drug product processes to support external and internal manufacturing operations globally. The team is responsible for supporting each drug product unit operation from freeze/thaw, through filling, inspection, labeling and packaging. The team is responsible for development, industrialization, troubleshooting and validation of drug product processes at manufacturing sites, both international and domestic. The Manager of Drug Product MSAT would serve as a process expert in equipment selection, CMO selection strategy, management of equipment qualification activities, and would be hands-on solving issues during technology transfer and cGMP start-up. This position is also responsible for ensuring site to site consistency after the processes are successfully transferred, providing floor support as necessary, reviewing process data and supporting investigations.
In this role a typical day might include, but is not limited to, the following:
- Lead an engineering and scientific team to develop and maintain fully characterized processes for biopharmaceutical drug products.
- Oversee activities in assigned area of expertise, which may include incoming inspection of components, developing and characterizing fill process parameters, manage technical transfer and validation of fill processes at CMOs, support activities in manufacturing, filling, device assembly, product labeling and primary and/or finished packaging.
- Partner with cross-functional internal and external teams to ensure successful process transfers.
- Review and/or approve manufacturing documentation associated with transferred processes.
- Provide on-site support during establishment of new or modified production processes, review process data to ensure operational robustness and consistency.
- Manage investigations related to assigned area to identify a root cause(s) and to identify and implement effective corrective and preventive actions.
- Develop organizational standards and systems for processes to meet growing product portfolio.
- Establish standard procedures for process development activities and integrate those with other Regeneron business and quality systems.
- Author technical reports and protocols in support of cGMP activities.
- Collaborate with internal and external teams to seek out opportunities to improve process performance and cGMP operations.
- Responsible for leading, coaching and developing direct reports.
- Travel to contract manufacturers or business partners, as required, approximately 25-50%.
To be considered for this opportunity you should have a BS/BA in a scientific, engineering or related field and 7 years of related experience in a pharmaceutical/biologics cGMP environment or equivalent. Experience interacting with Contract Manufacturing Organizations. Knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.) is required.
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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.