Scientist, GQLMAS Vaccines ELISA

Merck KGaA Darmstadt Germany • West Point, PA

111d • $85,600 - $134,800 • 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 a 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, transfer, technical troubleshooting, 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 2 years 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 to drive projects requiring coordination between multiple individuals or multiple representatives from other groups/departments
• 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 (biologics, vaccine) with experience in Immunochemical analytical Methods
• Knowledge of receptor pharmacology and 4PL curve analysis
• Experience with GMP compliance
• Familiarity with assay transfers, and equivalence studies
• Experience with deviation management
• Experience with Electronic Notebook and LIMS systems
• Experience with SoftMax Pro template creation
• Experience authoring technical documents
• 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 execution applying Good Documentation Practice (GDP) principles
• Management of individual project deliverables as they fit into the larger overreaching project timelines
• Driving deviation incidents and investigations through data gathering, hypothesis testing or other technical troubleshooting, as well as CAPA creation and implementation
• Authoring of technical documents, including protocols and reports
• Technical troubleshooting and identifying continuous improvement opportunities
• 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 biologic's 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