Research Associate II, Injectable Drug Product Development
Company: Planet Pharma
Location: New Haven
Posted on: June 12, 2021
The position is required to join Injectable Drug Product
Development group of our pharmaceuticals’ Analytical and
Pharmaceutical Development department. 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, particulates testing. The ability to work
with minimal supervision as well as part of the team is essential.
The position entails execution of the studies and data processing
and compiling to generate and support development reports as well
as other required documentation. Understanding of assay
development, biotherapeutics development is a plus.
Understanding of the basic principles of protein chemistry
and/or drug product process is required. Experience with
electronic record keeping software, like ELN, EndNote, e-logbooks;
maintenance of laboratory instrumentation (organizing PMs, data
backup, SW upgrade, etc.) and familiarity with design and
maintenance of databases will be a plus.
- Execute development studies for the pharmaceuticals’ drug
candidates and commercial products, support tech transfer
activities for internal manufacturing and contract manufacturing
- Assist in preparation of internal technical reports on the
executed studies with minimal supervision for the product
- Participate in Department meetings and other technical and team
- 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
- Ability to take initiative in problem solving and finding
solutions to scientific challenges with minimal supervision is
- 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
- Excellent interpersonal skills are required, as is the strong
ability to communicate effectively.
- BS in Chemistry, Biochemistry, Biophysics, Chemical
engineering, or relevant field with 2 to 4 years or MS in these
fields with 0 to 2 years of relevant experience is required. Solid
background in protein chemistry, chemistry, biochemistry,
toxicology or equivalent is highly preferred.
- Decision Quality
- Problem Solving Skills
- Drive for Results
- Expert knowledge of scientifc principles and concepts.
- Ability to be single department point of contact.
- Works on extremely complex problems in which analysis of
situations or data requires an evaluation of intangible
- Exercises independent judgment within broadly defined practices
and policies in selecting methods, techniques and evaluation
criteria for obtaining results
Keywords: Planet Pharma, New Haven , Research Associate II, Injectable Drug Product Development, Other , New Haven, Connecticut
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