Senior Associate Scientist I, Biochemical Analysis
Catalent Pharma Solutions
Summary
The Senior Associate Scientist I is primarily responsible for testing samples, participate in method transfer and validation activities, draft methods, and report data under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies.
Job description
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 (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
Benefits
- Medical benefits
- 401(k)
- 152 hours PTO
- 8 Paid Holidays
Company overview
Catalent Pharma Solutions, now known as Catalent, Inc., is a leading global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida. Founded in 2007 as a spin-off from Cardinal Health's pharmaceutical technologies segment, the company has grown into a major player in the pharmaceutical services industry. Catalent provides comprehensive drug development and manufacturing solutions including drug delivery technologies, formulation development, analytical testing, clinical and commercial manufacturing, clinical packaging, and supply chain services. The company operates over 50 facilities across four continents and has supported more than half of all FDA-approved products over the past decade. With approximately 16,900 employees, Catalent produces over 70 billion doses annually for more than 8,000 products, serving major pharmaceutical companies like Pfizer, Moderna, Novo Nordisk, and Bristol-Myers Squibb. In 2024, the company was acquired by Novo Holdings A/S for $16.5 billion, further strengthening its position in the global pharmaceutical manufacturing landscape.