Spclst, Quality Control

Merck & Co. • North Wales, PA

94d • $77,700 - $122,300 • Onsite

About The Position

The Global Biologics Lab in North Wales, Pennsylvania (NW4) is part of the Global Quality Large Molecule Analytical Sciences organization within our Company's Manufacturing Division and is responsible for providing global analytical support for our Company's in-line products to enable world-wide robust product availability and managing the materials and samples which are used as critical reference parameters in release and stability testing of biological products, named Biological Critical Reagents (BCRs). This position will work in a current Good Manufacturing Principles (cGMP) environment under the direction of the lab manager and will be expected to execute bioassays for large molecule critical reagents and contribute to maintenance of cGMP compliant labs. The candidate will work with colleagues to deliver high quality results for these assays by supporting assay execution, transfer, technical troubleshooting, and reagent qualification, ongoing monitoring and stability supporting our company's Biologic Critical Reagents.

Requirements

• Bachelor of Science degree in Biology, Chemistry, or other related disciplines with at least two (2) years of laboratory experience in a cGMP environment.
• Master of Science degree in Biology, Chemistry, and other related disciplines with one (1) year of laboratory experience in a cGMP environment.
• Ability to independently follow procedures and work within a cross-functional team.
• Ability to think critically and learn new techniques.
• Understanding and experience with analytical troubleshooting in biologic assay development or quality.
• Understanding and experience with bioassays, specifically immunoassays (such as ELISA, EIA) or other binding-based assay technology and/or biochemistry techniques.
• Experience with HPLC and CE.
• Excellent interpersonal and communication skills, oral and written.

Nice To Haves

• Statistical analysis experience with familiarity with JMP.
• Experience with electronic lab notebooks, LIMS systems, and electronic log systems.
• Organization and project management abilities.
• Experience working in a Good Manufacturing Practices (cGMP) laboratory environment.
• Knowledge of quality and compliance guidelines and manufacturing processes.
• Technical aptitude and desire to learn new equipment and associated software to enable digital build capabilities.
• Effective planning and time management skills.

Responsibilities

• Support the qualification, ongoing monitoring, and stability testing of BCRs.
• Support assay execution, transfer, technical troubleshooting and life-cycle management of the company's in-line biologics through lab testing and collaboration within the network.
• Execute analytical laboratory methods and analysis such as ELISA, HPLC, CE.
• Document laboratory work according to Good Manufacturing Principles (GMP) and manage activities like deviation management.
• Support deviations (incidents and investigations) through owning investigations, data gathering, hypothesis testing, root cause analysis or other technical troubleshooting, and implement associated CAPAs.
• Provide support in responding to regulatory questions.
• Support the transfer of BCRs of new biologic products from our Manufacturing Division Commercialization or Research Laboratories to the Global NW4 Biologics Lab.
• Engage with analytical teams for the initial BCR identification and qualification.
• Communicate project updates and issues in a timely manner and strive for continuous improvement.
• Participate in and lead improvement projects, as applicable.
• Routine laboratory management tasks including those related to equipment maintenance, safety and GMP compliance.

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.

What This Job Offers

• Job Type: Full-time
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree