CMC Staff Scientist

Location
Rensselaer, NY, United States
Posted
Feb 15, 2021
Ref
22867BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
Our Chemistry, Manufacturing, and Controls (CMC) Regulatory Sciences team is comprised of hardworking professionals with multifaceted scientific backgrounds and experience. We are looking for a CMC Staff Scientist to provide scientific assistance in formulating sound technical positions and documentation that support meeting departmental responsibilities and achieving regulatory and business goals. Our CMC Scientists design and analyze data from comparability studies to assess the impact of manufacturing changes on material and provide scientific clarity to regulatory documents as subject matter experts.

As a CMC Staff Scientist, a typical day might include the following:
  • Leading or participating on study teams for investigations and comparability studies.
  • Independently designing and analyzing studies to assess changes in a biopharmaceutical process or product.
  • Authoring and reviewing technical reports of biopharmaceutical production processes and to support regulatory filings.
  • Reviewing regulatory submissions, from a scientific perspective, to identify potential red flags that need further discussion with subject matter experts.
  • Assisting CMC Regulatory Sciences Specialists with writing responses to Agency information requests, when needed.
  • Participating in or leading CMC technical problem solving discussions affecting regulatory submissions and developing the technical description of this information within regulatory documents.
  • Reviewing product specifications to ensure methods and criteria are accurate.
  • Working cross-functionally to engage and understand developing biopharmaceutical technologies and help prepare an appropriate regulatory approach for their introduction.
  • May supervise others and provide direction regarding CMC Scientific support as determined by business needs.
  • Contributing to CMC project development teams in areas of deep technical expertise.

This role might be for you if you:
  • Possess strong knowledge of biopharmaceutical manufacturing processes, including validation and comparability studies.
  • Have hands-on experience with a wide variety of bio/physico/chemical analyses including chromatographic, spectroscopic and electrophoretic methods.
  • Exhibit excellence in scientific writing and communication.
  • Are a critical and analytical problem solver.
  • Can demonstrate good working knowledge of basic statistics.
  • Are familiar with protein chemistry and stability pathways.
  • Enjoy being in a highly visible role where you and the team can make a positive impact on our patients.
  • Consistently maintain professionalism in communication, maintaining composure under pressure.
  • Have a demonstrated history of consensus building and collaboration.

To be considered for this position you must have a PhD in (bio)chemical engineering, biochemistry or chemistry. A PhD in another related field may be considered. Applicants must have at least 5 years of broad research experience, preferably in the biopharmaceutical, pharmaceutical or chemical industry. Applicants with a relevant PhD and at least 8 years of related experience may be considered for CMC Senior Staff Scientist.

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. #LI-DR1