Associate Director Bioanalytical Method Development

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:
Lead team of scientists and their associates to develop bioanalytical methods for Analytical Sciences Department. Methods will primarily be geared towards Phase I drug candidates but will also entail creating more efficient methods for late stage and commercial programs. In addition to method development, the incumbent will respond to regulatory agency requests, plant investigations, and represent Analytical Sciences on cross-functional teams.

Staying abreast of new technology and introducing it into QC will also be a key component of the role.

This position will be responsible for developing assays from the following types of techniques:
SDS-PAGE, CE-SDS, IEF, cIEF, iCE, MCE, PCR, and ELISA.

This group will qualify the assays before transferring them to the Clinical Testing group in the Analytical Sciences department.

Essential Duties and Responsibilities may include, but are not limited to, the following:
- Department Subject Matter Expert in bioanalytical techniques, especially capillary based methods.
- Develop bioanalytical methods for clinical programs using the following techniques: SDS-PAGE, CE-SDS, IEF, cIEF, iCE, MCE, PCR, and ELISA. Author and/or approve development reports for these methods.
- Represent Analytical Sciences on interdepartmental teams and in meetings. Update senior management as needed on progress and strategy
- Design, write, and review/approve protocols for assay qualification/validation studies.
- Evaluate and make recommendations on new instrumentation and technology.
- Work with chemistry method development group to define analytical strategies for new molecules. Assist in specification creation as needed.
- Interface with Research organization to ensure methods and technology are consistent throughout the company
- Lead troubleshooting activities for established test methods used in development and release testing. Provide analytical support in troubleshooting process and formulation problems.
- As methods move through development, extensively characterize develop methods using design of experiments to determine the edge of failure.
- Assist scientists in establishing, developing, and/or optimizing bioanalytical methodology to test purity and the identity and concentration of impurities (product-related and process-related).
- Perform job duties with little to no direction from supervisor. Design scientifically sound studies and experiments being given only a general outline of the study goal.
- Tabulate results and write summary reports of assay development and validation studies.
- Using the available scientific literature, develop scientific arguments for white paper justifications and investigation conclusions.
- Write group SOPs and provides drafts of proposed test methods to QC.

Supervisory Responsibilities:
- Manage Scientists and high level associates. Manage junior associates as indirect reports

Knowledge, Skills & Abilities:
- Leader who can function independently and navigate ambiguity
- Strong knowledge of Biochemical principles, Electrophoresis, Protein chemistry, and Statistical analysis
- ICH and compendial guidelines
- Analytical chemistry (characterization and validation);
- Expert knowledge of quality by design and 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 MS with 12+ years experience or a PhD with 6- 8 years experience (Sr. Manager) or MS with 15+ years experience or a PhD with 8-10 years experience (Associate Director) in Chemistry, Biochemistry, or Bioengineering; may consider another degree discipline or position level with commensurate experience; cGMP experience is required.

Equipment:
- Electrophoresis - General Electric (slab), Beckman Coulter and Protein Simple (capillary)
- Analytical instrumentation including electrophoresis, 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 Pre-clinical Research and 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 for extended periods, walk, talk, see, and hear. 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 occasionally exposed to fumes or airborne particles and toxic or caustic chemicals.

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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