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 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.

Physical Environment and Requirements

• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.

• 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.

Expected Salary Range:

$70,100-78,000

The salary range, is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide

range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:

· All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.

· Our recruiting process includes multiple in person and/or video interviews and assessments.

· If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding.

· We never request payment, bank information, or personal financial details during our offer process.

Your security is important to us, and we encourage you to stay vigilant when job searching.

American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.