Compliance Specialist

Organization: 
Regeneron Pharmaceuticals
Job Location: 
Rensselaer,NY
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 markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.

Summary:
Support the IOPS Analytical Sciences organization as the point person for GMP compliance, data integrity, and laboratory investigations. The ideal candidate will be a detail oriented industry veteran who has spent time on the bench in a QC environment and has overseen a variety of GMP laboratory investigations.

Essential Duties and Responsibilities may include, but are not limited to, the following:
- Department Subject Matter Expert in GMP compliance and laboratory investigations.
- Conduct cross functional laboratory investigations that may span the entire QC department and coordination of resources from multiple departments.
- Represent Analytical Sciences on interdepartmental teams and in meetings. Update senior management as needed on progress and strategy
- Develop analytical strategy for resolving plant investigations, customer complaints, and OOS/OOT results
- Strive for continuous improvement in Laboratory Investigations practices to foster compliance and meet different regulatory expectations.
- Evaluate trends in release, in-process, and stability results.
- Able to identify laboratory errors, trend and initiate appropriate CAPAs to eliminate recurrences.
- Review and authorize test results accurately and on-time to meet aggressive timeline for submissions.
- Perform job duties with little direction from supervisor. Design scientifically sound studies and experiments to bring investigations to root cause.
- Produce and maintain accurate records.
- Write departmental SOPs within areas of expertise.
- Assist in performing laboratory inspections for GMP compliance, suggest and implement corrective actions to keep the laboratory in inspection ready state.

Supervisory Responsibilities:
- Individual contributor providing direction to laboratory analysts with respect to experimental design and documentation.

Knowledge and Skills:
- Expert knowledge of cGMP and laboratory investigation practices;
- Biochemical principles; Electrophoresis
- Chromatography;
- Analytical chemistry;
- Protein chemistry;
- Statistical analysis:
- Expert knowledge with regulatory expectations for investigations is preferred.
- Interpersonal, oral, presentation, and written scientific as well as business communication skills;
- Compliance and detail oriented with excellent presentation skills.
- Word processing, spreadsheet, database management, graphing, and presentation software.

Education and Experience:
- Requires MS with 2-5 years of experience or a BS with 5-8 years of experience in Chemistry, Biochemistry, or Bioengineering; may consider another degree discipline or position level with commensurate experience; cGMP experience is a must.

Equipment:Working knowledge of

- 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;
- 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 regularly exposed to fumes or airborne particles and toxic or caustic chemicals. The noise level in the work environment is usually moderate and is occasionally loud.

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 recruitment agencies:
Regeneron is using the agency management company, Candex - www.candex.com. 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.

Regeneron is an equal opportunity employer and is an affirmative action employer.

To apply for this position, please CLICK HERE