Formulation development associate

American Regent, Inc.•Brea, CA

4d•Onsite

About The Position

The Formulation Development Associate is responsible to assist formulation development scientist by executing the lab experiments to support the drug product development. Nature and Scope: 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.

Requirements

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.
Excellent attention to detail.
Flexibility and willingness to learn.
Sound judgment and ability to solve problems and troubleshooting.
Ability to comply with Company policies, procedures, work rules, and protocols.
Ability to adapt effectively to workplace changes and new job duties/responsibilities.
Ability to contribute in a fast-paced, highly dynamic environment.
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.
Ability to gown aseptically for work in a Clean Room environment.
Must have the ability to work around laboratories and manufacturing areas and stand on feet for approximately 4-8 hours.

Nice To Haves

Experience in pharmaceutical industry or related field, preferred.

Responsibilities

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.
Assist in manufacturing area upstream and downstream activities.
File materials, facilities and equipment documentation.
Comply with cGMP practices and regulations and safety guidelines.
Perform any other tasks/duties as assigned by management.