CMC Reg Sciences Scientist
Our Chemistry, Manufacturing, and Controls (CMC) Regulatory Sciences team comprises hardworking professionals with multifaceted scientific backgrounds and experience. We are looking for CMC Scientist to join our Sciences, Engineering and Technologies team (SETS). Our CMC Scientists provide scientific assistance in formulating sound technical positions and act as subject matter experts to address scientific and technical content for our global regulatory documents. The ideal candidate will have strong written and spoken communication skills and will provide scientific excellence within the team and cross-functionally.
As a CMC Scientist, a typical day might include the following:
- Facilitating and leading study teams for investigations and comparability studies and contributing to CMC project development teams in areas of deep technical expertise.
- 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.
- 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.
This role might be for you if you have:
- Hands-on experience with a wide variety of bio/physico/chemical analyses including chromatographic, spectroscopic, electrophoretic and bioassay methods.
- Good working knowledge of basic statistics.
- Familiarity with protein chemistry and stability pathways.
- Excellent scientific writing and communication skills.
- Demonstrated history of consensus building and collaboration between teams.
- Knowledge of biopharmaceutical manufacturing processes, including validation and comparability studies.
To be considered for the CMC scientist position you must have a PhD in chemical or biochemical engineering, biochemistry, chemistry or microbiology (a related field may be considered). We prefer research experience working in the biopharmaceutical, pharmaceutical or chemical industry. Level is determined based on qualifications relevant to the role.
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.