Associate QC Technical Resources Specialist

Rensselaer, NY, United States
Sep 04, 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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary: Support lifecycle management within the QC technical resources groups.

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

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

• Work with Analytical science to ensure method readiness to bring to QC commercial before process validation

• Monitor day-to-day method performance in QC lab and identify appropriate subject matter expert to help any method related issues

• Work with regulatory science, external manufacturing, partners and communicate timelines for method validation/transfers to managers in QC Tech Resources

• Communicate to management any delay in validation/transfer timelines

• Communicate method updates to partners and track progress of updates

• Coordinate and review method performance reports and quality metrics

• Implement multisite method harmonization and reviews of method performance

• Coordinate post transfer investigations between contract sites and collaborative partners

• Track team activities and timelines to ensure that the deliverables within the project plans are met and are on-time.

• Escalate issues as needed to management

• Act as subject matter expert and provide technical support as needed

• Coordinate multisite trending and reviews and communicate information as needed to subject matter experts

Knowledge, Skills and Abilities:

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Continuously drive to improve processes for improved performance

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

• Gathers and organizes information

• Meets commitments on time

• Follows directions; performs well-defined tasks

• Effective time management skills

• Seeks to identify continuous improvement needs

Education and Experience:

• Requires BS/BA in a life sciences field with 0-2 years of related experience in a cGMP

• Or equivalent combination of education and experience.

• Experience with method performance, validation and transfer activities preferred.

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, disability status, protected veteran status, or any other characteristic protected by law.