Biological Scientist II
2 days ago
Job Title: Biological/Chemical Scientist II
Pay Rate: $41 to $48/Hr
Duration: 6 Months
Location: Newark, DE
Shift: 8 AM to 4:30 PM Eastern time
This position is for the Healthcare Diagnostics Division.
We are looking for a Biological/Chemical Scientist II
- Responsible for Hybridoma and recombinant monoclonal antibodies manufacturing and qualification of antibodies, collaborating on all aspects of supply chain compliance.
- Leads productivity projects and collaborates with TechOps on technical troubleshooting, root cause investigation, and corrective action implementations.
- Drives qualification and optimization of hybridoma and recombinant cell lines to produce monoclonal antibodies using state-of-the-art single-use bioreactor technology, shaker flasks, and roller bottles.
- Creates required SOPs to clearly define (standard work), step-by-step, optimization of cell culture expression and qualification of monoclonal antibodies. This includes a clear description of the design of experiments (DOE), data interpretation, and application.
- The job entails the translation of business needs into prioritization of projects and workload to safeguard supply chain continuity.
- Proactively shares information by establishing data review at the various gates of the production and qualification of cell lines to produce monoclonal antibodies:
- Lead troubleshooting activities on commercial and new products. This includes but is not limited to batch record review, lot tracing, raw material evaluation, design, and execution of experiments.
- Lead simple to complex process change projects, including demonstrating feasibility, developing validation protocol, executing proper qualifications, and driving necessary changes (equipment, process, test method, procedure, training, etc.)
- Lead the product change using change management processes
- Collaborating in cross-functional and cross-site teams
- Coaching and mentoring junior members
- Process improvements using HPS methodologies, SPS, VSM
- Implementing change
Education & Experience:
- MS or Ph.D. – Biochemistry, Biology, Chemical Engineering, Biomedical Engineering, Chemistry, or related sciences
- Requires a basic theoretical and practical understanding of antibodies and their application to Immunochemistry.
- Strong business acumen is essential to properly manage shifting priorities in a fast-paced manufacturing environment.
- Understand general laboratory techniques such as aseptic techniques, mixing, filtration, etc.
- Familiar with Single Use Bioreactor technology and cell culture process optimization
- Know how to safely handle chemicals and biochemicals.
- Trained in good laboratory practices and good documentation practices.
- Strong written and verbal communication
- Leadership
- Coaching
- Interpersonal communication
- Problem-solving competency
- Decision Making
- Influence without authority
- Negotiation
- Integrity
- Empathy
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