Regeneron is currently looking for a Sr. Manager to join our Process Sciences Downstream Sciences and Investigations (DSIG) team. The Sr. Manager- Process Sciences leads a team responsible for the assessment of changes to raw materials and their impact to Manufacturing & product and oversight of the product stability characterization to enable process validation. This position also maintains awareness of industry and regulatory trends to manufacturing technologies and material sciences to assess and support implementation within IOPS to remain in the forefront of industry.
As a Sr. Manager- Process Sciences a typical day might include the following:
- Leads cross-functional teams in generating and analyzing data to assess raw material attributes for impact to new and existing manufacturing processes which include change notifications, secondary sourcing, raw material investigations, and impurity/byproduct/extractable risk assessments.
- Perform risk assessments for changes to raw materials to determine potential impact to the processes.
- Leads projects by developing appropriate plans, schedules, resource projections and other project deliverables . Coordinates studies and technical justifications, which may include authoring protocols, completing study protocols, and writing summary reports of results.
- Provide technical and scientific oversight to engineers and scientists to ensure accuracy and relevance of experiments or data analysis
- Build systems and structures by which to manage and prioritize work against business drivers and various departmental needs. Coordinates prioritization of activities with area management.
- Set goals and performance targets to guide individuals and functions to achieve greater success.
- Reviews and approves study protocols and summary reports generated by the process sciences staff against established procedures
- Leads team of process scientists and engineers who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Approves various documents relating to area function, including those listed above.
- Provide direction and assign work to personnel to meet goals and timings.
- Responsible for compliance monitoring of area operations, including lab and documentation activities
- Participates in regulatory and customer activities including audits and GMP inspections.
- Collaborates with functional departments to resolve issues.
- Some travel may be required (< 5%)
This role might be for you if you:
- Have previous leadership experience including leading a team to meet team goals, performance evaluation/feedback, and mentorship
- Have previous operational & scientific experience related to the biopharmaceutical industry.
- You continuously seek to improve processes for improved performance.
To be considered for this role you must hold a B.S in Engineering, Chemistry or Life Sciences; M.S or PhD is preferred. Leadership/supervisory experience is required. For various levels you must have the following:
- Manager Process Sciences: 7+ years of related experience
- Sr. Process Sciences : 8+ years of related experience
- Or equivalent combination of education and experience.
Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$106,400.00 - $203,000.00
Top Skills
What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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