Sr. Microbiologist

Location
Rensselaer, New York, US
Posted
Sep 14, 2018
Ref
13994BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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: Responsible for QC microbiological aspects of cGMP compliance and testing.

Essential Duties and Responsibilities include, but are not limited to, the following:
- Responsible for QC microbiological aspects of cGMP compliance and testing.
- Perform microbiological validations as needed for finished product and in process controls and buffers.
- Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed.
- Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate.
- Participate in cleaning and process validation activities involving microbiology as needed.
- Participate in the investigation of microbiological product OOS results and DNF as needed.
- Contribute to the preparation of technical proposals, amendments, reports and memoranda.
- Contribute toward creating and revising microbiological SOPs.
- Assist in scheduling of M/C and post incursion monitoring procedures with follow-up responsibility to provide test results.
- Assist in the review of EM and product release data.

Knowledge, Skills and Abilities:

• Ability to maintain integrity and honesty at all times

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Continuously drive to improve processes for improved performance

• Demonstrate respectful behavior at all times

• Accountable for technical performance and results of team

• Manage internal and external relationships

• Develop strategy and create metrics to measure effectiveness of strategy

• Translate ambiguity into actionable steps

• May manage others through influence rather than direct authority

• Ability to resolve conflicts and coach others on problem solving

• Handle issues appropriately and with a sense of urgency

• Prioritize based on business needs

• Identify and effectively communicate risks

• Ability to problem solve and identify root cause

• Ability to communicate at all levels and across various functions

Education and Experience:
- Requires BS/BA in Biochemistry, Chemistry, Biology or related field with 5+ years of relevant experience, preferably in the pharmaceutical or biotechnology industries. Must have experience with pharmaceutical documentation practices and demonstrated leadership skills.

Level to be determined based upon 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, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

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