Regeneron

We are seeking a Process Development Engineer II to join our Synthetic and Bioconjugation Scale-up Technologies (SBST) group as a part of our Preclinical Manufacturing & Process Development (PMPD) department. In this exciting new role, you will develop conjugation and purification processes for bioconjugation of proteins to a diverse range of small-molecules. You would work in close collaboration with cross-functional teams for process development and optimization using the principles of Quality by Design (QbD) to make the processes suitable for GMP production. This role also involves process scale-up and technology transfer of manufacturing related workflows to Contract Development and Manufacturing Organizations (CDMOs) or Regeneron based manufacturing suites to ensure timely and reliable entrance to the clinic through product commercialization.

A typical day in the role of Process Development Engineer I might include:

• Working at the bench to design and develop scalable, robust and controlled GMP-ready bioconjugation and purification processes
• Collaborating with analytical groups within or outside the organization to establish supportive analytical characterization techniques
• Discussing plans and data in multi-functional teams to evaluate processes and determine developmental goals and ensure integrated program success
• Proactively complying to lab safety and environmental safety expectations of both Regeneron and regulatory bodies such as Food and Drug Administration (FDA), Department of Transportation (DoT), etc.
• Using statistical design of experiments (DOE) to optimize bioconjugation processes including conjugation reactions, purification operations, and analytical characterization
• Partnering with External Manufacturing group and other key partners at Regeneron’s IOPS organization to provide technical assessment of CDMO’s intended for GMP production and successfully transferring processes with immediate, first-time success
• Researching, identifying, and developing new technologies to improve processes, generate predictive process models, and pioneer novel at-line/in-line process analytical technologies (PAT) to ensure robust and controllable bioconjugation and purification processes

This role may be for you if you:

• Enjoy working in the lab to advance exciting new drug modalities to patients
• Have strong initiative and aim to complete challenging tasks and learn new technologies
• Have a strong fundamental understanding of various protein purification and technology transfer principles
• Are capable of multi-tasking and working both independently and in a collaborative environment involving multi-functional teams.
• Have excellent interpersonal, verbal and written communication skills
• Can think critically and demonstrate problem-solving skills

To be considered for this role, you musth have at least a Bachelor's/Master's degree with 3+ years of relevant experience in chemical/biochemical engineering or a related field. Experience with antibodies in the bioconjugates space is highly preferable. Hands on experience with bioconjugation processes (lysine-based, cysteine-based, site-specific etc.) with practical knowledge of downstream purification techniques such as chromatography, ultrafiltration/diafiltration, membrane technologies etc. is preferred. Experience with a variety of analytical characterization tools such as electrophoresis, mass spectrometry, high-performance liquid chromatography (HPLC), UV spectroscopy, etc. is preferred

Note: title will be commensurate with experience

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)

$77,600.00 - $126,600.00