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Process Development Engineer III - Synthetic Process Chemistry

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Mar 23, 2023

Job Details

Regeneron's Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a hardworking and dynamic Process Development Engineer III for its new Synthetic and Bioconjugation Scale-up Technologies (SBST) group. In this exciting new role, you will conduct synthesis of small molecule (cytotoxic or non-cytotoxic), synthetic route identification and/or optimization, process development & optimization using the principles of Quality by Design (QbD), 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 III might include:

  • Designing and developing scalable, robust and controlled GMP-ready processes for chemical synthesis of small-molecules. This includes purification development and establishing supporting analytical characterization techniques.
  • 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.
  • Ensuring a team-based evaluation of processes by working closely with several groups such as R&D chemistry, Formulations Development, Analytical Chemistry, and Protein Biochemistry to ensure integrated program success.
  • Generating robust technology transfer documentation and supporting production with onsite presence during scale-up/GMP manufacturing activities.
  • Partnering with External Manufacturing group and other key partners at Regeneron’s IOPS organization to vet CDMO’s and successfully transfer processes with immediate, first-time success.
  • Developing new technologies for process improvements and predictive process models, and pioneering novel at-line/in-line process analytical technologies to ensure robust processing.
  • Reviewing and providing domain expertise for all regulatory submissions.
  • Authoring publications, reports, tech transfer documents, regulatory support documents, patents.
  • Performing long-term planning for laboratory related personnel, supplies and equipment.

This role may be for you if you:

  • Have strong initiative and aim to complete challenging tasks and learn new technologies.
  • Are capable of multi-tasking, working both independently and within a team environment.
  • Have excellent interpersonal, verbal and written communication skills.
  • Can think critically and demonstrate problem-solving skills.

This role requires a Ph.D. or Master’s in organic chemistry or a related field. At least 2-3 years of industrial experience post-PhD or at least 5 years of experience post-Master’s in active pharmaceutical ingredient (API) process development is preferred. Experience with small-molecules in the bioconjugates space will be highly preferable. Hands on experience with organic molecule synthesis and characterization tools such as mass spectrometry, nuclear magnetic resonance (NMR), infrared (IR) spectroscopy, high-performance liquid chromatography (HPLC) etc. is preferred. Candidate must be well-versed with purification techniques such as crystallization, extraction, chromatography etc. Experience with solid-phase and liquid phase peptide synthesis is preferable. Proven experience in scaling-up synthetic small-molecule reactions and technology transfer to a GMP manufacturing facility is a plus. Candidate should be well-versed with International Council for Harmonization (ICH)/regulatory guidelines and their impact on process development of synthetic molecules and bioconjugates. Experience in working with multi-functional Chemistry, Manufacturing and Control (CMC) teams and experience in authoring publications, reports, tech transfer documents, regulatory support documents, patents is a plus.

Note: title will be commensurate with experience

#pmpd

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.


 

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)

$114,900.00 - $187,500.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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