American Regent
Formulationdevelopmentassociate
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Formulation development associate at American Regent. Skills: formulation development, laboratory experiments, cGMP documentation practices, cGMP practices and regulations. Assist formulation development scientist by executing the lab experiments to support the drug product development.. Assist in development of process manufacturing system, products, equipment, formulas, processes, or methods.”
Industry & Context.
Sound judgment and ability to solve problems and troubleshooting
Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves., Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision., Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly., Employee must be able to occasionally lift and/or move up to 50 pounds., Extensive use of laboratory equipment, chemicals, and biological materials., Ability to gown aseptically for work in a Clean Room environment., Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC) areas., Must have the ability to work around laboratories and manufacturing areas and stand on feet for approximately 4-8 hours.
What They're Looking For.
Must Have
B. S. or M. S. degree in pharmaceutical science, chemistry, biology, or life science related field., Understanding of basic lab skills., Ability to understand implement general GMP concepts., Practice safety in all aspects., Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves., Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision., Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly., Ability to gown aseptically for work in a Clean Room environment.
Nice to Have
Experience in pharmaceutical industry or related field, preferred.
What You'll Do.
Assist formulation development scientist by executing the lab experiments to support the drug product development.
Assist in development of process manufacturing system
Conduct laboratory formulation experiments for the development of drug candidates.
Maintain R&D laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed.
Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions.
Assist in manufacturing area upstream and downstream activities.
facilities and equipment documentation.
Comply with cGMP practices and regulations and safety guidelines.
Perform any other tasks/duties as assigned by management.
How You'll Work.
Team & Collaboration
Collaborate with process development and operations and escalate issues affecting company deliveries.
Full Job Description
**Nature and Scope** The Formulation Development Associate is responsible to assist formulation development scientist by executing the lab experiments to support the drug product development. **Essential Duties and Responsibilities** Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. * Assist in development of process manufacturing system, products, equipment, formulas, processes, or methods. * Conduct laboratory formulation experiments for the development of drug candidates. * Maintain R&D laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed. * Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions. * Collaborate with process development and operations and escalate issues affecting company deliveries. * Working knowledge of producing a high level of documentation accuracy and clarity according to cGMP documentation practices (GDP). * Assist in manufacturing area upstream and downstream activities. * File materials, facilities and equipment documentation. * Comply with cGMP practices and regulations and safety guidelines. * Others as assigned and required to meet relevant 21 CFR Part 210 and 21. * Perform any other tasks/duties as assigned by management. **Education Requirements and Qualifications** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * B.S. or M.S. degree in pharmaceutical science, chemistry, biology, or life science related field. * Experience in pharmaceutical industry or related field, preferred. * Understanding of basic lab skills. * Ability to understand implement general GMP concepts. * Practice safety in all aspects. * Excellent attention to detail. * Flexibility and willingness to learn. * Sound judgm
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