Associate Scientist Injectable Drug Product Development

Job Type: W-2 | Contract Duration: 12 months |

Location:

New Haven, CT | 100% ONSITE

Our client is seeking an Associate Scientist to join the Injectable Drug Product Development group. This position is required to conduct studies to enable Drug Product characterization activities, including combination products at high protein concentration, as well as commercial products. The job entails experimental work on various aspects of Drug Product characterization, including formulation development, safety risk assessment of excipients as well as process reagents, extractables and leachables, in-use compatibility studies for intravenous and subcutaneous administration, process development to support drug product manufacturing support, and particulates testing.

• Execute development studies for drug candidates and commercial products, support tech transfer activities for internal manufacturing and contract manufacturing sites.
• Assist in preparation and delivery of internal technical reports and presentations on the executed studies with minimal supervision.
• Participate in Department meetings and other technical and team building activities.
• Generate and support development reports and other required documentation through data processing and compiling.

• BS in Chemistry, Biochemistry, Biophysics, Chemical Engineering, or a relevant field with 2+ years of experience, or MS degree with 1+ years of relevant experience.
• Scientific and practical knowledge of protein chemistry, chemistry, biochemistry, or equivalent drug product processes.
• Ability to take instructions and execute experiments and other activities with minimal supervision.
• Collaborative working style with ability to adhere to timelines with minimal supervision.
• Excellent interpersonal and communication skills.

• Previous experience in biotherapeutics development and understanding of the biopharmaceutical lifecycle and factors impacting protein molecule stability.
• Understanding of assay development and biotherapeutics development.
• Hands‑on experience with instrumentation used in protein pharmaceutical and analytical development as well as characterization, and knowledge of cGMP and quality guidelines.
• Experience with electronic record‑keeping software (e.g., ELN, End Note, e-logbooks); maintenance of laboratory instrumentation (organizing PMs, data backup, SW upgrade, etc.) and familiarity with design and maintenance of databases.
• Initiative in problem solving and finding solutions to scientific challenges with minimal supervision.

ITech Consulting Partners