What are the responsibilities and job description for the Scientist I, BioChemical Analysis position at Catalent?
Position Summary
The Scientist I is primarily responsible for method evaluation, optimization, transfer and validation activities under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies. Also responsible for drafting technical documents such as methods, method forms, validation protocols and reports.
The role:
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
- Shift: Monday-Friday 8am-5pm
- 100% on-site
The Scientist I is primarily responsible for method evaluation, optimization, transfer and validation activities under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies. Also responsible for drafting technical documents such as methods, method forms, validation protocols and reports.
The role:
- Perform method evaluation, optimization, transfer, and validation activities under cGMP guidance
- Execute analytical testing for biologics using techniques such as HPLC/UPLC, electrophoresis, spectroscopy, and compendial assays
- Draft and review technical documents including methods, validation protocols, and reports
- Perform ad hoc sample testing and support method lifecycle activities
- Follow standard operating procedures with strong attention to detail
- Ensure accurate, legible, and compliant documentation in accordance with cGMP requirements
- Perform peer review of laboratory notebooks, logbooks, and technical documentation
- Train and coach peers on methods, instrumentation, and laboratory practices
- Bachelor’s Degree in Life Sciences or Physical Science with 6 years of relevant experience, OR
- Master’s degree with 4 years of relevant experience, OR
- Doctorate degree in Life Sciences or Physical Science
- Applied knowledge of scientific principles in Biology, Chemistry, or Biochemistry
- Experience with analytical techniques (HPLC/UPLC, CE, spectroscopy, etc.)
- Experience working in a cGMP-regulated environment
- Experience with method development, transfer, validation, or optimization
- Experience drafting/reviewing technical documents (methods, protocols, reports)
- Competitive medical benefits and 401K
- 152 hours PTO 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.