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Scientist - Pharmaceutical Development
2 months ago
We are seeking a highly skilled Associate Research Scientist to join our Injectable Drug Product Development group within the Analytical and Pharmaceutical Development department. The successful candidate will be responsible for conducting studies to enable Drug Product characterization activities, including combination products at high protein concentration, as well as commercial products.
Key Responsibilities- Conduct experimental work on various aspects of Drug Product characterization, including formulation development, safety risk assessment of excipients as well as process reagents, extractables and leachable, in use compatibility studies for intravenous and subcutaneous administration, process development to support drug product manufacturing support, particulates testing.
- Execute development studies for pharmaceuticals' 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 for the product candidates.
- Participate in Department meetings and other technical and team building activities.
- BS in Chemistry, Biochemistry, Biophysics, Chemical engineering, or relevant field with 2+ years of experience or MS degree with 1+ years of relevant experience is required.
- Solid background in protein chemistry, chemistry, biochemistry, or equivalent is highly preferred.
- Position requires scientific and practical knowledge of protein chemistry or drug product process.
- Previous experience in biotherapeutics development as well as understanding of the biotechnology products life cycle and factors impacting protein molecule stability is a plus.
- Hands-on experience with instrumentation, used in protein pharmaceutical and analytical development as well as characterization and knowledge of cGMP and quality guidelines is a plus.
- Ability to take initiative in problem solving and finding solutions to scientific challenges with minimal supervision is preferred.
- Shows ability to take instructions and execute experiments and other activities with minimal supervision is required.
- The individual must be able to work in a collaborative setting and has ability to adhere to timelines with minimal supervision is essential.
- Excellent interpersonal skills are required, as is the strong ability to communicate effectively.
