Manager, External Manufacturing (CMO) - Rensselaer, NY | Biospace
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Manager, External Manufacturing (CMO)

Regeneron Pharmaceuticals, Inc.

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Location:
Rensselaer, NY
Posted Date:
8/19/2017
Position Type:
Full time
Job Code:
10295BR
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

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: The External Manufacturing Manager provides technical and process support for all aspects of clinical and commercial parenteral drug product operations in the External Manufacturing Network. Coordinates all aspects of manufacturing operations including oversee day-to-day operations, ensure timely completion of associated operations/documentation and assist in the monitoring of cGMP compliance at drug product contract manufacturers.

Essential Duties and Responsibilities include, but are not limited to:
* Serve as the primary Regeneron technical contact for select DP contract manufacturing sites concerning day-to-day activities.
* Liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners.
* Ensure the timely routing and review of all master manufacturing records (MRs), standard operations procedures (SOPs), tech transfer reports, validation master plans, and other documentation related to clinical and commercial drug product manufacturing at contractors and/or business partners.
* Coordinated all DP Manufacturing activities at contract and/or business partner manufacturing sites, including but not limited to: scheduling of all batches, supply of materials, direct shipment of bulk and finished product at manufacturing site, track and monitor cycletimes, and providing any required associated reports and technical expertise.
* Travel to contract manufacturers or business partners, as required.
* Provide regulatory filing supports (IND, BLA, MAA, etc.).
* Maintain required training status on Regeneron specific work instructions and SOP's.
* Lead sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
* Support all investigations which concern DP Manufacturing or associated shipping operations, when required.
* Ensure product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.
* This role will report to a Strategic Relations leader within the External Manufacturing organization.
* Ability to travel up to 50% (domestic and international).

Knowledge, skills, and abilities:
* Extensive knowledge and experience with full-scale drug product manufacturing from formulation through the final package.
* Strong interpersonal, written and oral communication skills.
* Fluent in English with a preference given to candidates with competencies in German and/or French (oral and written).
* Broad knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
* Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.
* Experience with documentation and quality systems.
* Prior knowledge in Advanced Planning systems is desired.
* Exhibits a degree of ingenuity, creativity and resourcefulness in evolving and ambiguous environments.
* Understands and listens to team members and stakeholders needs while supporting productive team environments toward one common objective.
* Driven for proactive resolution of technical challenges with tact, diplomacy and composure.
* Shows resiliency and flexibility in the face of challenges and adversarial situations.
* Able to provide clear direction to others in ambiguous situations and environments.
* Exhibits confidence and a high emotional IQ.
* Experience in collaborating with CMOs/CROs.
* Provide regulatory filing support (IND, BLA, MAA, etc.)

Requirements



Education and Experience:
* Senior Manager requires a minimum of a BA/BS in any physical or biological science with 12+ years industry relevant experience, 11+ years with MS or 8+ years with PhD.
* Manager requires a minimum of a BA/BS in any physical or biological science with 10+ years industry relevant experience, 9+ years with MS or 5+ years with PhD.
* Associate Manager requires a minimum of a BA/BS in any physical or biological science with 8+ years industry relevant experience, 7+ years with MS or 2+ years with PhD.

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.