Quality Control Scientist (Drug Product)

Location
Rensselaer, New York, United States of America
Posted
Jul 23, 2021
Ref
25056BR
Required Education
Bachelors Degree
Position Type
Full time
A Quality Control Scientist (Drug Product) executes the drug product fill and finish projects with

responsibilities in components test method development and validation, and design verification and validation. Develop analytical

methods for the assembly process development for clinical and commercial combination products. We are looking for a Scientist with strong engineering background with understanding of good

manufacturing practice.

In this role a typical day might include the following:
  • Process development for the assembly and packaging of clinical and commercial combination products, including vials, prefilled syringes, safety system, auto-injector, and novel delivery systems
  • Works closely with cross-functional team, including Combination Product Development subject matter experts, Quality and others to assure project success
  • Facilitates transfer of newly developed physical test methods to internal and external QC functions as needed to support design transfer activities.
  • Generates documentation needed to support characterization, method development, method validation, and device design verification testing activities
  • Documents deviations, performs investigations, and implements corrective/preventive actions as required.


This job might be for you if:
  • You have strong written and verbal communication
  • You enjoy writing technical documents such as test reports, technical memos, test protocols and input requirements documents
  • You have experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820) and ISO 14971
  • You value a culture of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments
  • You enjoy mentoring and training others on systems and processes
  • You enjoy working in a fast-paced environment and are flexible to changing requirements

To be considered for this position applicants must have a PhD in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences, or related field, and a minimum 1-year experience in the pharmaceutical, biotechnology or medical device industries. GMP experience is strongly desired.

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.