Description:
Strong business acumen essential to properly manage shifting priorities in a fastpaced manufacturing environment. Job entails translation of business needs into prioritization of projects and workload to safeguard supply chain continuity. Leads productivity projects and collaborates with TechOps on technical troubleshooting root cause investigation and corrective action implementations.
Requires basic theoretical and practical understanding of antibodies and their application to Immunochemistry.
Functions and responsibilities include but not limited to
Reports to Manager responsible for Hybridoma and recombinant monoclonal antibodies manufacturing and qualification of antibodies collaborating on all aspects of supply chain compliance.
Drives qualification and optimization of hybridoma and recombinant cell line 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) stepbystep optimization of cell culture expression and qualification of monoclonal antibodies. This includes clear description of design of experiments (DOE) data interpretation and application.
Proactively shares information by establishing data review at the various gates of the production and qualification of cell line to produce monoclonal antibodies:
Lead troubleshooting activities on commercial and new product. 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
Skills
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 on good laboratory practices good documentation practices.
Strong written and verbal communication
Leadership
Coaching
Interpersonal communication
Problem solving competency
Decision Making
Influence without authority
Negotiation
Integrity
Empathy
Requirements:
Degree:
MS or Ph.D. Mechanical Engineering Industrial Engineering Chemical Engineering Biomedical Engineering Electrical Engineering Biochemistry Biology Chemistry or related sciences