Associate Manager QC Microbiology (Validation)

Rensselaer, New York, US
Oct 01, 2018
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, 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: Manages employee performance by providing relevant, high-impact feedback. Ensures self and staff keep up-to-date on technical knowledge and developments that impact roles. Responsibilities will also include interaction with other managers, and personnel outside the department, to resolve product quality issues, corrective actions, investigations and participate in process improvements.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Ensures work is allocated effectively and controls are set for monitoring performance.

• Reviews and approves routine evaluations.

• Liaises with direct supervisor to facilitate review and approval of non-routine evaluations and atypical results.

• Drafts, reviews and approves internal procedures and protocols associated with test methods and commercial support activities.

• Ensures laboratory conforms to quality, safety, biosafety and governmental standards, including equipment maintenance and calibration.

• Participates in the identification and implementation of continuous improvement initiatives to increase efficiency and capacity.

• Review and approve investigations.
Leader of team responsible for all raw material, in-process and product assay validations. This is testing is generally performed in-house but may involve working with contract labs.

Additional responsibilities for Associate Manager include, but are not limited to:

• Ensures self and staff keep up-to-date on technical knowledge.

• Ensures an effective learning environment by coaching employees, orchestrating learning opportunities.

• Assists in interviewing, hiring and onboarding for employees.

Knowledge, Skills and Abilities:

• Demonstrates strong leadership abilities through direction, influence and personal action.

• Strong computer skills including knowledge of Excel, Word and PowerPoint.

• Proven ability to work independently and effectively handle multiple priorities is a must.

• Ability to maintain confidentiality of proprietary information expected.

• A good team player that takes initiative to complete tasks diligently and correctly.

• Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within an organization.

• Demonstrable command of cGMP's as well as current compendia (USP/SMEWW/EP) and Guidance Documents (ISO, FDA).

• Ability to analyze problems via the scientific method and draw data supported conclusions.

• Expert and demonstrable applied microbiological theory and skills, especially those related to diagnostic and pathogenic microbiology.

• Firm understanding of applied microbiological sciences (e.g., cleanroom, speciation, indicators).

• Ensures self and staff keep up-to-date on technical knowledge and developments that impact roles.

• Continuously drive to improve processes for improved performance.
Education and Experience:

• Requires BS/BA in Life Sciences or equivalent along with 6+ years of relative experience (pharmaceutical or biotechnology industries). Will substitute relevant work experience in lieu of degree requirement. Prior leadership experience is required.

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.