Process Sciences Associate - Control Development& Lifecycle Management

Location
Rensselaer, New York
Posted
Jan 22, 2022
Ref
REGEA0026R6619
Required Education
Bachelors Degree
Position Type
Full time

Regeneron is currently looking for a Process Sciences Associate for our Process Control Development and Lifecycle Management Team with a Monday – Friday, 8 am-4:30 pm schedule. Regeneron has successfully commercialized numerous antibody therapies. Gaining approval from regulatory agencies is dependent on demonstrating that our processes are robust, consistent, and produce quality product, done in part through process controls applied to our production processes. The Process Sciences Associate will collect and analyze data from across the business to develop robust Process Control programs, set appropriate limits using scientific rationale and statistical processes, and communicate and present information to cross-functional teams throughout a molecule’s life cycle and/or during technology transfer. This role involves writing and reviewing documents that support Manufacturing, Quality Control, and Chemistry Manufacturing Compliance (CMC) Regulatory Departments. In this fast-paced environment with a strong pipeline, a Process Sciences Associate in the Process Control Development and Lifecycle Management Team has an opportunity to work on countless aspects of the process and business.

As a Process Sciences Associate a typical day might include the following:

  • Collecting, analyzing, and drawing conclusions related to manufacturing control strategy from data in source documents, including but not limited to: development studies, enrichment studies, process validation and characterization studies, chemical stability studies, and historical manufacturing data.
  • Compiling and organizing information and evaluating product and process risks, and providing justifications for implementing process controls or for making updates to existing process control programs.
  • Drafting of process control documents, including Process Control Strategy documents, In-Process Control (IPC) Development Reports, and Process Performance Monitoring Plans, including setting relevant limits using appropriate scientific rationale or statistical analysis, where appropriate.
  • Technical and scientific writing of assessments to summarize criticality of product attributes to recommend appropriate testing at release pools and support creation of specifications.
  • Completing and/or reviewing IPC documentation associated with batch manufacture or for regulatory filings.
  • Coordinating with team members to obtain additional data as needed to support creation, updates, and changes to process control programs.
  • Understanding, defending, and presenting on process control program structure, rationale, and methodologies during cross-functional meetings and to senior leadership when required.
  • Participating in brainstorming sessions where we look for ways to continuously improve our Process Control Development and Lifecycle Management processes.

This role might be for you if you:
  • Understand antibody manufacturing processes.
  • Enjoy working in a fast-paced environment.
  • You are detail oriented, quality driven and well organized.
  • You have the dedication to balance multiple projects, prioritize them and complete them independently, while excelling at keeping all impacted parties well informed.
  • Can address new and sometimes ambiguous challenges, learning quickly.
  • You enjoy a team environment but can also take ownership of multi-faceted projects and technical reports.
  • Can develop and drive scientific and/or business-related improvement ideas.
  • Are proficient in Microsoft Suite (Word, Excel, Powerpoint).

To be considered for the Process Sciences Associate you must be willing and able to work Monday-Friday, 8am-4:30pm. For various levels you must have the following:

Process Sciences Associate I: BS/BA in life sciences/engineering or related field; Chemical Engineering or Biochemistry preferred

Process Sciences Associate II: BS/BA in life sciences/engineering or related field; Chemical Engineering or Biochemistry preferred and 2+ years of relevant experience

Process Sciences Associate III: BS/BA in life sciences/engineering or related field; Chemical Engineering or Biochemistry preferred and 5+ years or relevant experience

Process Sciences Associate IV: BS/BA in life sciences/engineering or related field; Chemical Engineering or Biochemistry preferred and 8+ years or relevant experience

Experience with statistics and material science is preferred. The level is determined based on qualifications relevant to the role.

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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