Manager Clinical Testing & Process Support

Organization: 
Regeneron Pharmaceuticals
Job Location: 
Rensselaer, NY
Job Description: 

If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.

Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.

Summary:
Operational manager of analytical sciences department’s routine testing functions. This encompasses DS and DP release and stability testing for Phase I and Phase II drug programs as well providing analytical support to the Process Sciences (PS) department to complete process validation analytical testing for late stage candidates. PS support will also include analytical support for plant investigations and small scale studies. The incumbent will be responsible for scheduling testing and non-testing activities to meet aggressive timelines dictated by regulatory submission dates as well as product release and stability schedules.

This will include review of the data to ensure it meets technical and GMP standards. The manager will be responsible for assays from the following types of techniques: SDS-PAGE, CE-SDS, IEF, cIEF, iCE, HPLC, UPLC, ELISA, and PCR. This group will receive these assays from the method development groups in the Analytical Sciences department and will ultimately transfer them to the appropriate Quality Control (QC) departments when drug programs transition to Phase III.

Essential Duties and Responsibilities may include, but are not limited to, the following:
• Manage multiple groups within department focused on routine testing.
• Set laboratory testing schedule and communicate to reports and across organization
• Represent Analytical Sciences at interdepartmental deviation meeting. Set strategy for resolving department deviations. Update senior management as needed on progress
• Ensure data is reviewed and authorized in a timely manner
• Ensure GMP compliance within the group
• Lead laboratory investigations, driving to root cause
• Perform job duties with little to no direction from supervisor. Able to navigate ambiguity and changing priorities.
• Strive for continuous improvement and operational efficiency within the group
• Work with QC project management and other functions to determine sample forecast and priority
• Maximize analyst and instrument productivity
• Write group SOPs and provides drafts of proposed test methods to QC.
• Transfer methods to commercial QC organization.
• Keep laboratory in inspection ready state

Supervisory Responsibilities:
• Manage up to 8 direct reports and 6 indirect reports

Knowledge and Skills:
• Biochemical principles;
• Electrophoresis
• Chromatography;
• Analytical chemistry
• Protein chemistry;
• Statistical analysis:
• Operational management
• Expert knowledge of cGMP;
• Interpersonal, oral, presentation, and written scientific as well as business communication skills;
• Word processing, spreadsheet, database management, graphing, and presentation software.

Education and Experience:
• Requires BS with 5 years relevant experience and 2-5 years supervisory experience in Chemistry, Biochemistry, or Bioengineering QC laboratory; may consider another degree discipline or position level with commensurate experience; cGMP experience is required. Strong track record of organizational efficiency and continuous improvement preferred.

Equipment:
• Electrophoresis - General Electric (slab), Beckman Coulter and Protein Simple (capillary)
• Analytical instrumentation including HPLC, spectrophotometry, and microplate reader equipment;
• Computer and general office equipment.

Business Contacts:
• Process Sciences, Risk Management, Manufacturing, QA, QC, Document Control, CMC Regulatory, CMC Project Management, and Tarrytown Process Development;
• Equipment and supply vendors.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use hands to manipulate objects or controls, sit, stand, walk, talk, see, and hear. The employee will primarily be working at a desk. Must be able to wear personal protective and/or safety equipment as needed.

Work Environment/Hazards:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee is exposed to fumes or airborne particles and toxic or caustic chemicals when observing analysts in the laboratory. The noise level in the work environment is usually moderate and is occasionally loud.

We offer a competitive compensation and benefits package including stock incentives, 401k with company match, as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.

EOE/M/F/D/V

Disclaimer: Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. 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 without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means. Moving forward, Regeneron is using the agency management company, Candex - www.candex.com

ARCALYST, EYLEA, and ZALTRAP are trademarks of Regeneron Pharmaceuticals, Inc.

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