QC Equipment Project Manager

Rensselaer, NY, United States
Sep 04, 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, 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: The QC Equipment Project Manager will be responsible for project management activities related to onboarding of novel and non-standard cGMP instrumentation (e.g. Robotics) used in the Quality Control laboratory. Responsibilities include, but are not limited to requirements gathering, equipment procurement, installation, system integration, qualification activities, and overall project ownership / management. The position will facilitate all lifecycle activities in a timely manner to enable QC laboratories to execute their functions as well as championing new fully automated systems for better efficiency in QC.

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

• Responsible for seeking and implementing novel and non-standard instrumentation (including laboratory robotics) which automate testing within the Quality Control Laboratories.

• Oversees the configuration of equipment software platforms and associated file structures to meet regulatory and internal data integrity requirements. Ensures system integration with existing systems (ex. LIMS, Historian).

• Leads projects and prioritizes using excellent organizational, communication and time management skills

• Communicate project progress and risks to upper management and stakeholders (internal and external)

• Manage the day-to-day detailed aspects of multiple projects simultaneously

• Coordinates contingency and risk mitigation planning for projects.

• Acts as Project Owner for, and directly participate in, system requirement generation, instrument installation, SOP development, and qualification activities for novel and non-standard instrumentation.

• Conduct instrument/robot testing or feasibility studies (hardware and software)

• Acts as liaison with Tarrytown Automation group, QC testing groups, IT, Lab Systems and QA Validation

• Provide mentoring to staff that support the equipment onboarding program.

• Prepare and provide KPI and performance metrics to upper management

• Ensures meeting minutes and weekly/monthly reports are completed accurately.

• Complies with all pertinent internal, cGMP (Part-11 and Data Integrity), and regulatory agency requirements

• Initiate, author, and review quality compliance records as CC's, EOE's, NOE's, DNF's, risk assessments, impact statements and corrective/prevention action plans.

• May manage a team of Project Specialists who assist in managing sub-projects for these programs.

Knowledge and Skills:

• Strong project management, interpersonal, cross-cultural, communication, negotiation and problem-solving skills are essential.

• Driven for proactive resolution of project related issues with tact, diplomacy and composure.

• Technical knowledge of electronic system integration and/or qualification is essential

• Knowledge in analytical testing and associated cGMP systems is preferred

• Demonstrated ability to successfully manage projects is required

• Ability to communicate effectively, both in writing and verbally, are essential

• Time and management skills with the ability to multi-task are essential

• Shows resiliency and flexibility in the face of challenges and adversarial situations.

Education and Experience :

• BS/BA in Life Sciences, Engineering, or related field preferred plus 10 years of experience; may substitute relevant experience for education.

• Experience with automated/robotic lab equipment preferred

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.