Regeneron is currently looking for a Principal Drug Product Engineer to join our Material Sciences team. This role supports the development and industrialization of aseptic drug product filling processes, critical process parameters and ranges, filling requirements, equipment and process troubleshooting and validation of drug product processes at our new fill/finish manufacturing site.
As a Principal Drug Product Engineer, a typical day might include the following:
- Design and conduct studies to assess materials used in the Drug Product manufacturing process.
- Collaborates with cross-functional teams and with external organizations to support drug product process development efforts to be transferred to Contract Manufacturing Organizations (CMOs) as well as internally.
- Develops and reviews formulation processes for manufacturing and writes protocols and product industrialization reports to support and plan technology transfer processes and process validation.
- Manages investigations associated with drug product fill processes to identify a root cause(s) and to identify and implement effective corrective and preventive actions.
- Develops validation procedures reflecting best practices in the industry.
- Utilizes in-house analytical lab and designs studies to support drug product process development.
- Provides regulatory filing support for drug product (IND, BLA, MAA, etc.) as well as support during regulatory inspection of site quality systems.
- Performs and reviews process investigations and product impact assessment for change controls and internal/external investigations.
- Performs hands-on experiments and in-process testing to support process development and product industrialization.
- 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.
- Continuously drives to improve processes for improved performance.
- Supports and mentors colleagues at various levels within the organization.
- Up to 20% travel may be required.
This role might for you if you:
- Have a background in aseptic processing, drug product development or pharmaceutical development preferred.
- Can resolve conflicts and coach others on problem-solving.
- Are accountable for the technical performance and results of the team.
- Can manage ambiguity well.
- Can manage others within a matrixed team using influence.
To be considered for the Staff Drug Product Engineer you must have a BS in Engineering. For various levels you must have the following:
- Sr. Drug Product Engineer: 5+ years of relevant experience
- Principal Drug Product Engineer: 8+ years of relevant experience
Experience with aseptic processing, drug product development, or pharmaceutical development is preferred. Level is determined based on qualifications relevant to the role.
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)