Job Description

Job Type: W-2 Contract

Duration: 12 months

Location: New Haven, CT, Onsite 4-5 days a week

Position Overview:

Our pharmaceutical client is seeking an Associate Scientist I to join the Injectable Drug Product Development group within the Pharmaceutical Development and Clinical Supply (PDCS) department. Engage in experimental work on various aspects of drug product characterization, including formulation development, in-use compatibility studies for intravenous and subcutaneous administration, process development to support drug product manufacturing, and particulates testing. This role requires the ability to work both independently and as part of a team.

Responsibilities:

• Design and Execute Studies: With some supervision, design and execute development studies for clinical drug candidates and commercial products. Characterize protein drug conformational and colloidal stability using industry-standard methodologies (e.g., circular dichroism, differential scanning fluorimetry, analytical ultracentrifugation, size-exclusion chromatography).
• Prioritize Tasks: Manage and prioritize multiple assigned tasks and projects effectively, working independently and as part of a team.
• Execute Drug Development Studies: Conduct physico-chemical characterization, particulates testing, and stability studies for drug candidates and commercial products.
• Prepare Technical Reports: Assist in preparing internal technical reports on executed studies with minimal supervision.
• Participate in Development Teams: Collaborate in cross-functional development teams.

Qualifications:

Required:

• Experience: 0 to 2 years of relevant work experience with a pharmaceutical or biotechnology company.
• Education: BS or MS degree in Biochemistry, Pharmaceutical Science, Chemical Engineering, or a relevant field.
• Technical Skills: Solid understanding of protein stability, thermodynamics, and protein degradation mechanisms. Experience with H/UPLC’s, imaged capillary electrophoresis (iCE/Maurice), Ion Exchange Chromatography (IEX), Micro-flow imaging (MFI), light obscuration (LO), DLS, NanoTemper, and DSC is desirable.
• Experiment Execution: Ability to execute experiments with minimal supervision.
• Collaboration: Ability to work in a collaborative setting and adhere to timelines.
• Communication: Excellent interpersonal, collaborative, and communication skills.
• Software Proficiency: Proficiency in MS Office programs (Word, Excel, Outlook, PowerPoint).
• Physical Requirements: Ability to lift/carry 15/30 pounds unassisted/assisted; work in a controlled environment with biological, infectious, and hazardous materials; gown/degown PPE; use a computer; communicate via phone, video, and electronic messaging; engage in problem solving and collaborative work during standard business hours.

Preferred:

• Technical Skills: Experience with sub-visible particulates characterization and testing, biophysical and analytical testing.
• Regulatory Knowledge: Familiarity with regulatory guidelines.
• Software Proficiency: High-level proficiency in MS Office software, electronic record keeping software (e.g., ELN, EndNote, e-logbooks); maintenance of laboratory instrumentation (organizing PMs, data backup, SW upgrade).
• Problem Solving: Ability to take initiative in problem-solving and finding solutions to scientific challenges.
• Communication: Excellent people skills and strong communication abilities.

Be a part of a team that contributes to cutting-edge drug product development and makes a significant impact on the lives of patients with rare diseases. Apply now to join our client's innovative and collaborative environment.

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