Process Sciences Associate (Validation)

Rensselaer, NY, United States
Aug 24, 2019
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Supports the Manufacturing and Process Sciences Departments through the activities and documentation related to validation of manufacturing bioprocesses.

Level to be determined based on qualifications relevant to the role.

Essential Duties and Responsibilities may include, but are not limited to, the following:

• Draft process validation protocols for process performance qualification and associated studies.

• Execute protocol-driven studies, analyze data using statistical methods and author technical reports.

• Provide periodic on-the-floor coverage during process validation campaigns as required.

• Present data from qualification studies as required.

• Perform scientific investigations and document within the Quality System, and identify CAPAs and execute Change Controls.

• Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer.

• Apply statistical process control tools in monitoring the manufacturing process.

• Participates in process and quality risk assessments, including process FMEAs.

• Assist in troubleshooting and continuous improvement activities associated with the manufacturing process.

• Support off-site transfer team as needed.

• Review and/or approves manufacturing documentation associated with the transferred processes.

• Serve as functional area subject matter expert in regulatory inspections.

• May manage projects related to process validation and continuous improvement initiatives.

Knowledge, Skills & Abilities:

• Ability to maintain integrity and honesty at all times

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Demonstrate respectful behavior at all times

• Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)

• Gathers and organizes information

• Ability to learn skills quickly and apply new concepts

• Follows directions; performs well-defined tasks

• Effective time management skills

• Seeks to identify continuous improvement needs

Education and Experience:

• Requires BS/BA in life sciences/engineering or related field; Chemical Engineering or Biochemistry preferred. May consider another degree discipline with relevant experience or coursework; cGMP experience is desirable.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.