Project Manager Quality Control (Robotics)

Rensselaer, New York, US
Aug 12, 2018
Quality, Quality Control
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: Manage and provide technical leadership for the development, implementation and support of robotics and automation initiatives within the Quality Control department. Ideal candidate would have experience with implementation of modern automation or robotics in a cGMP laboratory environment.

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

• Define, coordinate and manage timelines for all Quality Control activities related to implementation and support of QC laboratory automation/robotics initiatives, including:
o Equipment purchase and qualification.
o Future laboratory design and buildout.
o Development of relevant standard operating procedures (SOPs).
o Equipment and Analytical Method validation/qualification.

• Work with subject matter experts to define scope, tasks and deliverables. Make linkages across departments to ensure that projects stay on track and fully supported across the organization.

• Develop and monitor project plans and schedules for QC onboarding of new test methods and products into the automation lab

• Technical evaluation of method changes for impact to automated processes within QC.

• Provide support for investigations and other quality processes.

• Lead cross functional teams and manages the deliverables for the assigned projects. Drives projects through completion within timeline, quality and budgetary constraints.

• Provide guidance to QC Management in assessing resource, equipment and space needs.

• Proactively identify issues and provide general guidance to resolve QC operational concerns and work with leadership to develop solutions to meet objectives.

• Regularly interact with Sr. Management or executive levels. Exercise judgment and exert some influence on the overall objectives and long-range goals of the QC Department. Represent the department in relevant internal/external committees.

• Serve as a primary point of contact among functional areas for QC automation activities.

• Lead special projects as assigned by supervisor/department management.

Knowledge, Skills and Abilities

• Excellent written, verbal and interpersonal communication skills

• Ability to communicate at all levels and across various functions

• Manage internal and external relationships

• Ability to handle multiple projects and priorities with exceptional organizational and time management skills.

• Prioritize based on business needs

• Identify and effectively communicate risks

• Ability to problem solve and identify root cause

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

• BS in Life Sciences or related field with 10+ years of relevant experience, preferably in the Pharmaceutical industry. Will consider Engineering or similar degree, with relevant laboratory experience.

• Project Management experience required. PMP certification is considered a plus.

• Familiarity with equipment and software qualification/validation.

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.