What are the responsibilities and job description for the Biological/Chemical Scientist/Engineer 2 position at Softpath System?
Strong business acumen essential to properly manage shifting priorities in a fast-paced 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), step-by-step, 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
Requirements : Degree :
MS or Ph.D. - Mechanical Engineering, Industrial Engineering, Chemical Engineering, Biomedical Engineering, Electrical Engineering, Biochemistry, Biology, Chemistry, or related sciences
