Research Associate II, Injectable Drug Product Development

Company: Planet Pharma
Location: New Haven
Posted on: June 12, 2021

Job Description:

Position Summary

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.

Principal Responsibilities

• Execute development studies for the pharmaceuticals’ drug candidates and commercial products, support tech transfer activities for internal manufacturing and contract manufacturing sites
• Assist in preparation of internal technical reports on the executed studies with minimal supervision for the product candidates
• Participate in Department meetings and other technical and team building activities

Qualifications

• 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.

Education

• 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.

Competencies

• Accountability
• Collaboration
• Decision Quality
• Problem Solving Skills
• Perseverance
• Drive for Results

Skill Level:

• 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 variables
• 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