Associate Director CMC Sciences, Engineering, & Technologies
Regeneron Pharmaceuticals Inc

Rensselaer, New York

Posted in Pharmaceuticals
about 1 month ago


This job has expired.

Job Info


Our Chemistry, Manufacturing, and Controls (CMC) Regulatory Sciences team comprises hardworking professionals with multifaceted scientific backgrounds and experience. We are looking for an Associate Director, CMC Regulatory Sciences to lead our Sciences, Engineering and Technologies team (SETS).The SETS team designs, analyzes and interprets data from product comparability studies to assess the impact of manufacturing changes on product. 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 foster a culture of scientific excellence within the team and cross-functionally.

As an Associate Director CMC Regulatory Sciences, a typical day might include the following:
• Leading a team of scientists and providing scientific direction to the team that is responsible for:
• 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.
• Working cross-functionally to engage and understand developing biopharmaceutical technologies and help prepare an appropriate regulatory approach for their introduction.
• Building and maintaining relationships with multiple departments focused on technical initiatives and problem solving

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 we have a strong preference for a PhD in biochemistry, chemistry, or another related field. Applicants with a PhD must have at least 5 years of broad research experience, preferably in the biopharmaceutical, pharmaceutical or chemical industry. Applicants with a relevant Master's degree and at least 8 years of related pharmaceutical industry experience may be considered.

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.
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