Manager QC Microbiology (Compliance)

Location
Rensselaer, NY, United States
Posted
Aug 05, 2019
Ref
16862BR
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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary: Responsible for managing a team of Supervisors and analysts within the QC Microbiology department for a cGMP biopharmaceutical manufacturing facility. Act as an area manager for deviations, corrective and preventative actions and change controls. The ideal candidate will have experience with investigations.

Responsibilities:

• Support manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice on QC related topics as needed.

• Oversees the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate.

• Ensures that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).

• Review and approve investigations, SOPs and reports.

• Manage support of Product Testing and Environmental Monitoring as required.

• Participate in inspections for regulatory/internal/customer.

• Ensure a safe working environment within the laboratory.

• Proactively identifies and implements improvements and lean initiatives.

• Oversees laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.

• Ensures that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures.

• Presents analytical data reports clearly and concisely to senior management, including QC performance metrics and trends.

Knowledge, Skills and Abilities:

• Ability to build, lead, and motivate team

• Ability to communicate at all levels and across various functions

• Manage internal and external relationships

• Develop strategy and create metrics to measure effectiveness of strategy

• Lead through ambiguity and translate into actionable steps

• Provide leadership to direct and indirect reports

• Coaching and conflict resolution

• Handle issues appropriately and with a sense of urgency

• Prioritize based on business needs

• Ability to problem solve and identify root cause

Education and Experience:

• Requires BS/BA in Microbiology or related life sciences discipline and 7+ years of relevant experience within the pharmaceutical or biotechnology industry along with previous supervisory and/or leadership experience.

• Experience with electronic systems such as LIMS, Qumas, eDoc, Trackwise, etc., is an advantage.

• In depth knowledge of current regulatory requirements in support of cGMP manufacturing operations.

Preferred Laboratory Experience
o Bioburden
o Microbial Identification
o Water Testing - Endotoxin
o Environmental monitoring
o Cleaning and validation studies
o Familiar with USP, JP and EP methodology

* Level to be determined based on 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, disability status, protected veteran status, or any other characteristic protected by law.