Regeneron is currently looking for a Principal Drug Product (DP) Engineer to join the Combination Product Process Sciences organization. This role will provide engineering support for the design and development of combination product processes, including assembly, packaging, and/or inspection, and will be part of a team responsible for industrialization, troubleshooting, and validation of combination product processes across manufacturing sites. This role will include supervision of up to two direct reports.
In this role, a typical day might include the following:
- Provide engineering expertise to support cross-functional teams to collaboratively define and execute combination product process development and technology transfer activities.
- Design and implement scale-up strategies for combination product unit operations with a focus on process characterization, identification of critical process parameters and process optimization.
- Write and review product industrialization protocols and reports to support technology transfer and process validation.
- Support product life-cycle initiatives.
- Support process investigations and assist with product impact assessment for change controls and internal/external investigations.
- Perform at-scale hands-on experiments and in-process testing to support process development and product industrialization.
- Continuously drive to improve processes for improved performance.
- Perform personnel management functions including time sheet submissions, training, purchase requisitions, expense reports and performance management.
This role might be for you if:
- You are a problem-solver, are willing to take action, self-starter.
- You show eagerness to apply expertise in diagnosing inefficiencies, resolving root causes, and recommending solutions to challenges.
- You will establish and cultivate highly effective partnerships with colleagues that support and advance project goals and objectives.
- If you like to tinker, investigate, test, reverse engineer devices.
- If you want to be a part of a fun, dynamic, challenging, and inclusive environment.
- You can quickly learn complex processes and write technical documentation.
- You have demonstrated experience and knowledge in the following areas (beneficial but not required):
- Combination device assembly, packaging, and labeling production operations
- Transfer and/or development of regulated medical devices, combination products, or drug products
- Regulatory and industry standards such as 21 CFR 4, 21 CFR 210, 21 CFR 211, 21 CFR 820, ISO 13485 and ISO 14971
- Equipment and process validation best practices, i.e. IQ, OQ, PQ, PPQ.
- Industry practices (cGMP, Annex I) across multiple health authorities (e.g. FDA, EMA, MHRA, etc.)
- Study design and statistical analysis methods
- Root cause analysis tools and methods
To be considered for the Principal Drug Product Engineer role you must have a BS in engineering; mechanical engineering, biomedical engineering or chemical engineering is preferred. For various levels you must have the following:
- Principal DP Engineer: BS in engineering; mechanical engineering, biomedical engineering or chemical engineering is preferred and 8+ years of experience or equivalent combination of education and experience.
- Staff DP Engineer: BS in engineering; mechanical engineering, biomedical engineering or chemical engineering is preferred and 10+ years of experience or equivalent combination of education and experience.
Experience managing/leading personnel is strongly preferred. Experience with aseptic processing, drug product development, combination product development is preferred. Level is determined based on qualifications relevant to the specific 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)
$86,900.00 - $166,000.00