W2 Position :: Associate Clinical Scientist at Woodbridge, CT || (Onsite)

Overview

Remote
On Site
Depends on Experience
Full Time
No Travel Required

Skills

tissue
cell
laboratory
material
Drug
injectable
formulation
Bio

Job Details

Associate Clinical Scientist

6+Months

Woodbridge, CT (Onsite 5 days per week)

 

Woodbridge ONSITE 5 DAYS PER WEEK/ PARKING REIMBURSED

Key Responsibilities:
- Lead and execute studies for Drug Product characterization, particularly for products with high protein concentrations and combination products.
- Engage in formulation development for injectable drug products.
- Perform safety risk assessments for the selection of excipients and process reagents.
- Conduct extractable and leachable studies to ensure product safety and compliance.
- Oversee in-use compatibility studies for drugs intended for intravenous and subcutaneous administration routes.
- Develop and refine manufacturing processes to support drug product production.
- Carry out particulate matter testing in accordance with industry standards.
- Independently execute research studies while also effectively collaborating with a team.
- Process experimental data and contribute to the development of technical reports and documentation needed to support product development stages.

Key Qualifications:
- Proven experience in the pharmaceutical industry with direct experience in drug product development.
- Understanding of protein chemistry principles and/or drug product processing techniques.
- Demonstrated capability to work autonomously and as part of a multidisciplinary team.
- Proficient in the utilization of electronic laboratory notebooks (ELN), reference management software (e.g., EndNote), and electronic logbooks.
- Practical knowledge in the operation and maintenance of laboratory equipment, including arranging preventative maintenance, data archiving, and software updating.
- Familiarity with the creation and upkeep of specialized databases is advantageous.
- Familiarity with assay development and biologics product development will be considered an added advantage.

Educational and Experience Requirements:
- A Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field.
- Extensive experience in pharmaceutical development, particularly with injectable drug products.