Senior Associate Scientist I, Biochemical Analysis
Catalent
Summary
The Senior Associate Scientist I is primarily responsible for testing samples, participating in method transfer and validation activities, drafting methods, and reporting data under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies.
Job description
Position Summary
The Senior Associate Scientist I is primarily responsible for testing samples, participating in method transfer and validation activities, drafting methods, and reporting data under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies.
The Role
- Perform sample testing for biologics under cGMP regulatory guidance
- Participate in method transfer and validation activities
- Draft methods, method forms, and analytical reports
- Execute laboratory testing using techniques such as HPLC/UPLC, electrophoresis, spectroscopy, and compendial assays
- Follow standard operating procedures with strong attention to detail
- Ensure accurate, legible, and compliant documentation in accordance with cGMP
- Perform peer review of laboratory notebooks, logbooks, and method documentation
- Operate laboratory equipment safely and in compliance with procedures
The Candidate
- Bachelor's Degree in Life Sciences or Physical Science with 2+ years of relevant experience, OR
- Master's degree in Life Sciences or Physical Science (no experience required)
- Knowledge of scientific principles in disciplines such as Biology, Chemistry, or Biochemistry
- Experience working in a laboratory environment with analytical techniques
- Experience or exposure to cGMP regulations and compliance requirements
- Experience with analytical techniques (HPLC/UPLC, electrophoresis, spectroscopy, etc.) preferred
- Strong written and verbal communication skills
- Strong attention to detail and documentation accuracy
- Ability to multitask and manage multiple priorities
- Ability to work independently and meet deadlines in a fast-paced environment
Requirements
- Bachelor's Degree in Life Sciences or Physical Science with 2+ years of relevant experience, OR Master's degree in Life Sciences or Physical Science
- Knowledge of scientific principles in Biology, Chemistry, or Biochemistry
- Experience working in a laboratory environment with analytical techniques
- Experience or exposure to cGMP regulations and compliance requirements
- Experience with analytical techniques (HPLC/UPLC, electrophoresis, spectroscopy) preferred
- Strong written and verbal communication skills
- Strong attention to detail and documentation accuracy
- Ability to multitask and manage multiple priorities
- Ability to work independently and meet deadlines in a fast-paced environment
Benefits
- Medical Benefits
- 401(k)
- 152 Hours PTO
- 8 Paid Holidays
Company overview
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) that serves as a trusted partner to pharmaceutical, biotech, and consumer health companies worldwide. Founded on a legacy dating back to 1933, Catalent has evolved into a comprehensive drug development and delivery leader with over 40 global sites. The company specializes in providing end-to-end solutions spanning oral dose formulations, biologics, specialty products, and clinical supply services. Catalent's expertise includes formulation development, analytical services, commercial manufacturing, and advanced delivery technologies such as Zydis® fast-dissolve tablets and softgel technologies. With over 1,000 active development programs at any given time, the company launches more than 100 new products and line extensions annually and has supported half of all FDA approvals over the past decade. Catalent produces over 60 billion treatment doses per year, helping approximately 200 million patients annually. Headquartered in Tampa, Florida, the company employs more than 10,000 professionals globally who are dedicated to putting patients first and championing the missions that matter in healthcare innovation.