Manager- Drug Product (Tech Transfer)

Regeneron is currently looking for a Manager to join our Drug Product (DP) Manufacturing Sciences and Technology (MSAT) team. The Manager leads a team of employees responsible for the development of robust drug product processes that enable Regeneron’s mission to deliver life transforming medications to patients globally. The team is response for supporting each drug product unit operation from freeze/thaw, through filling and inspection. The team is responsible for development, industrialization, troubleshooting and validation of drug product processes at manufacturing sites, both international and domestic. This role serves as a process expert in equipment selection, CMO selection strategy, management of equipment qualification activities, and will be hands-on solving issues during technology transfer and cGMP start-up. The position is also responsible for ensuring site to site consistency after the processes are successfully transferred, provides floor support as necessary, reviews process data to ensure operational consistency and supports investigations.

           

As a Manager DP MSAT, a typical day might include the following:

• Oversees activities in assigned area of expertise, which may include incoming inspection of components, developing and characterizing fill process parameters, managing technical transfer and validation of fill processes at CMOs, supporting activities in manufacturing, filling, device assembly, product labeling and primary and/or finished packaging.
• Responsible for leading, coaching and developing direct reports.
• Partners with cross-functional internal and external teams to ensure successful process transfers.
• Reviews and/or approves manufacturing documentation associated with transferred processes.
• Provides on-site support during establishment of new or modified production processes, reviews process data to ensure operational robustness and consistency.
• Manages investigations related to assigned area to identify a root cause(s) and to identify and implement effective corrective and preventive actions.
• Develops organizational standards and systems for processes to meet growing product portfolio.
• Establishes the standard procedures for process development activities and integrates those with other Regeneron business and quality systems.
• Authors technical reports and protocols in support of cGMP activities.
• Establishes an internal and external network to stay abreast of current regulatory environment and industry standards.
• Supports innovation mindset within organization and encourages development of novel ideas.
• Travels to contract manufacturers or business partners, as required, approximately 25-50%.

This role might be for you if you:

• Have experience interacting with Contract Manufacturing Organizations.
• Can demonstrate technical expertise in drug product manufacturing and/or product development and validation.
• Have knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.).
• Have strong interpersonal, cross-cultural, communication, negotiation and enjoy project management and problem-solving.

To be considered for the Manger DP MSAT you must have a BS/BA in a scientific, engineering or related field. For various levels you must have the following:

• Associate Manager DP MSAT: BS/BA in a scientific, engineering or related field and 6 years of related experience in a pharmaceutical/biologics cGMP environment or equivalent combination of education and experience.
• Manager DP MSAT: BS/BA in a scientific, engineering or related field and 7 years of related experience in a pharmaceutical/biologics cGMP environment or equivalent combination of education and experience.
• Sr. Manager DP MSAT: BS/BA in a scientific, engineering or related field and 8 years of related experience in a pharmaceutical/biologics cGMP environment or equivalent combination of education and experience.

Level is determined based on qualifications relevant to the role.

#Hybrid

#MB-1

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.

Salary Range (annually)

$86,900.00 - $194,200.00