Lead QC Data Reviewer

Rensselaer, NY, United States
May 23, 2019
Quality, Quality Control
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: Performs data review to support release, stability programs and lab operation for Early phase, Pre-Clinical molecules in the QC Analytical Sciences laboratories as well as perform laboratory investigations.

**Schedule is Sun-Thurs*

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

• Perform detailed data review for analytical test results generated by QC department for compliance with cGMP, internal SOPs and Specifications to support production, stability studies and lab operation.

• Review release and stability data, trend charts of reference standards, lab equipment calibration records and log-books and other review function as needed. Testing encompasses ELISAs, DNA by PCR, Gel Electrophoresis, HPLC assays and Isoelectric focusing.

• Performs laboratory investigations for unexpected results working with cross functional teams to identify root cause and corrective actions

• Perform detailed data review for analytical test results generated by contract testing labs to assure their correctness and accuracy and help them with failure investigation.

• Maintain and update relevant SOPs for data review and reporting as needed

• Interact with Stability and other peer groups to support stability report writing and regulatory updates.

• Complies with all pertinent regulatory agency requirements.

• Participates in required training activities.

• May be responsible for supporting and maintaining a special project for data review.

Lead-Related Activities include, but are not limited to, the following:

• Provides on-the-floor guidance and support to employees;

• Ensures employees timesheets are completed on time;

• Monitors employees training to ensure that all requirements are met, including OJT

• Maintain up to date training records for self and direct reports

• Perform minimally monthly performance feedback meetings with direct reports;

• Escalates all performance issues to management and/or HR

Knowledge, Skills & Abilities:

• Ability to interpret and communicate information.

• Ability to prioritize, manage multiple tasks, and meet deadlines

• Ability to organize and maintain data or information

• Ability to maintain integrity and honesty at all times

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Contiouously drive to improve processes for improved performance

• Demonstrate respectful behavior at all times

• Ability to interpret data and develop improvement plan

• Initiating the development of leadership skills by providing training and guidance to others

• Anticipates and plans for change

• Critical thinking skills

• Demonstrates analytical skills through problem-solving

• Demonstrates leadership by being approachable

• Participates in projects in addition to daily responsibilities

Education and Experience:

• Requires BS/BA in Chemistry, Biology or related field with a minimum of 5 years of experience. May substitute other relevant experience in lieu of educational requirement.

Level to be determined 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.