Job - Associate Scientist – Injectable Drug Product Development
Location : New Haven, CT (100% onsite)
Duration : 12 months
Job Overview
This role is part of the Injectable Drug Product Development (IDPD) group at Pharmaceuticals. The Associate Scientist will contribute to drug product characterization and development studies for both drug candidates and commercial products , including high-protein combination products.
The position requires hands-on experimental work data analysis , and preparation of technical documentation to support development and manufacturing of biologic drug products.
The role demands the ability to work independently and collaboratively in a team environment.
Key Responsibilities
Experimental Work & Drug Product Development
- Conduct studies for drug product characterization (formulation, compatibility, stability).
- Support development of combination and commercial products.
- Evaluate excipients and process reagents for safety risks.
- Conduct extractables, leachables, and particulates testing.
- Support process development for drug product manufacturing.
Data Analysis & Reporting
Compile experimental data and generate development reports.Prepare and deliver technical reports and presentations.Maintain accurate electronic records (ELN, e-logbooks, EndNote).Collaboration & Communication
Participate in department meetings and team activities.Support tech transfer activities to internal and contract manufacturing sites.Collaborate effectively with colleagues across multiple teams.Lab & Instrumentation Maintenance
Maintain laboratory instrumentation (preventive maintenance, software updates, data backup).Assist in database design and maintenance for experimental data.Required Qualifications
Education :
BS in Chemistry, Biochemistry, Biophysics, Chemical Engineering, or related field with 2+ years of experience , ORMS degree with 1+ years of relevant experienceTechnical Knowledge :
Protein chemistry or drug product process understandingAbility to perform experiments with minimal supervisionExperience with electronic lab notebooks (ELN) and record keepingSoft Skills :
Strong collaboration and interpersonal communicationAbility to meet timelines independentlyPreferred Qualifications
Solid background in protein chemistry, biochemistry, or chemistryExperience in biotherapeutics development and understanding of protein stabilityHands-on experience with analytical instrumentation used in pharmaceutical protein developmentKnowledge of cGMP and quality guidelinesDemonstrated ability to problem-solve independently