Associate Scientist (R1), GQLMAS Bioassay Vaccines

Merck KGaA Darmstadt Germany • West Point, PA

114d • $70,500 - $110,900 • Onsite

About The Position

Global Quality Large Molecule Analytical Sciences, in our Manufacturing Division, provides global analytical support for our company's in-line products to enable world-wide robust product availability. Our Manufacturing & Supply Division is committed to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners create an interdependent global manufacturing network that is committed to delivering high quality, reliable supplies to customers and patients on time, every time. We are seeking a highly motivated individual to join our team as an Associate Scientist in our Bioassay Vaccine group supporting our in-line vaccine programs. This position will work in a Good Manufacturing Principle (GMP) environment under the direction of a laboratory lead and will be expected to execute bioassays for vaccines such as immunoassays (i.e. ELISA) and enzyme activity assays 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, method transfer, technical troubleshooting, reagent qualification and life-cycle management of methods supporting our company's in-line vaccines.

Requirements

• Bachelor's degree in Biology, Chemistry, Biochemistry, or related scientific field
• At least 1 year of relevant experience in analytical method execution, development, validation, and/or quality control (QC)
• Understanding and experience with bioassays, specifically immunoassays (such as ELISA, EIA) or other binding-based assay technology
• Ability to independently follow procedures and work within a cross-functional team
• Ability to think critically and learn new techniques
• Good technical communication (oral and written), interpersonal, and teamwork skills
• Self-motivated with a positive attitude

Nice To Haves

• Experience working in a Good Manufacturing Practices (cGMP) laboratory environment in the area of large molecules (vaccines, biologics)
• Experience in Immunochemical analytical methods
• Knowledge of receptor pharmacology and 4PL curve analysis
• Experience with GMP compliance
• Experience with Electronic Notebook and LIMS systems
• Technical aptitude and desire to learn new equipment and associated software to enable digital build capabilities.

Responsibilities

• Analytical ELISA and enzyme activity method execution and analysis
• Documentation of laboratory applying Good Documentation Practice (GDP) principles
• Management of individual project deliverables as they fit into the larger overreaching project timelines
• Supporting deviation incidents and investigations through data gathering, hypothesis testing or other technical troubleshooting
• Second Person Review of electronic notebooks and technical documents
• Routine laboratory management tasks including those related to equipment maintenance, safety and GMP compliance
• Ability to work independently and within cross-functional project teams
• Commercial life-cycle management of the vaccine analytical strategy
• Supporting System Development Life Cycle through development of electronic templates and protocols (i.e., SMP, D300), and documentation authoring, execution and reviewing.

Benefits

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

What This Job Offers

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