Sr Manager QA Validation (Drug Product MFG)

Location
Rensselaer, NY, United States
Posted
Jul 16, 2019
Ref
16701BR
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: Responsible for internal and external collaborations to develop validation strategies related to external validation, the review and approval of validation and qualification documentation related to external validation efforts, and for providing on-site support at external sites during validation efforts.

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

• Developing validation approaches with CMC teams such that external validation efforts align with commercial expectations and are timely with regards to planned regulatory filing dates.

• Reviews and approves validation documentation associated with filling, visual inspection, labeling, assembly, product sterilization, packaging and technology transfer. Documentation may include Validation plans, development reports, process control strategies, protocols, reports and risk assessments.

• Ensures on-site support at CMOs/partner sites during validation activities, which may include:
o Project "kick-off" meetings or other planning meetings.
o Filling, labeling and assembly, sterilization, and packaging processes.
o Data review for the timely approval of reports.

• Reviews Regulatory filing sections related to completed external validation activities.

• Interfaces routinely with internal teams including CMC, Drug Product, External Manufacturing, QC, QA and Regulatory.

• Achieves quality and validation objectives by contributing information reflecting best practices in the industry and recommendations to strategic plans and reviews.

• Resolves problems, identifies issues and determines system improvements.

• Lead special projects as assigned.

• Manages a team such that documents are reviewed and approved as needed for external validation efforts and on-site support is provided as appropriate.

• Ensures team members are adequately trained for each area of review, as applicable.

Education and Experience:

• Requires BS/BA in Engineering, Chemistry, or Life Sciences with 8+ years of related experience within the field of Biotech Process sciences, Validation, Manufacturing or related field.

• Experience in cGMP operations and managing of personnel is required.

*Level will be determined based on skills and related 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, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
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