QC Assay Transfer Specialist

Albany, New York
Oct 24, 2017
Pharm Country
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 the IOPS site by managing technology transfer processes to/from contractors and partners.

Essential Duties and Responsibilities include, but are not limited to, the following:
* Work with all relevant departments to coordinate technology transfer activities
* Contribute to Method life cycle management program
* Track team activities and timelines to ensure that the deliverables within the project plan are met and are on-time.
* Contribute to change controls in Technical Resource Team
* Coordinate all IOPS communications to and from collaborative partners.
* Coordinate testing activities in QC in support of assay transfer
* Act as subject matter expert and provide technical support during transfer process
* Review technology transfer protocols and reports, manage document exchange (which includes Regeneron documents such as SOPs, SPECs, validation, raw material and instrument qualification documents, batch records, etc.);
* Prepare, distribute & present project status reports to project team members and management.
* Lead special projects as assigned

Knowledge, Skills and Abilities:
* Ability to prioritize, manage multiple tasks, and meet deadlines
* Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices
* Excellent written and oral communication skills

Education and Experience:
* Requires BS/BA with a minimum of 3 years of related experience in a cGMP environment.
* Level will be determined based on skills and experience.

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.