Research Scientist II

Nature and Scope

The Research Scientist II executes activities related to developing and validating methods for product/project, conducts method validation in compliance with ICH, USP/EP etc., and performs sample testing using HPLC, UV, GC, particle sizer, pH meter, etc. to provide support for formulation development and process development.

Essential Duties and Responsibilities

Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

• Conduct analytical studies in support of formulation development, process development, process scale-up, and regulatory filing.

• Organize and prepare samples for analysis by external laboratories.

• Develop and validate analytical methods for raw materials, in-process and finished product under cGLP/cGMP, ICH, USP/EP Guidelines.

• Prepare protocols and reports for method validation, analytical test methods, technology transfer, and stability studies.

• Provide training new scientists to perform analytical methods and instruments.

• Troubleshoot and maintain analytical equipment.

• Observe and maintain compliance, safety regulations, cGLP/GMP guidelines, and company policies and procedures.

• 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.

• BS or MS degree in pharmaceutical science, chemistry, biology, or life science related field.

• 4+ years of method development and validation experience in the pharmaceutical industry.

• Experience of analytical instrument techniques UV, HPLC, GC etc.

• Experience on analytical method development and validation for assay and impurities.

• Extensive experience on protocol writing, technical report creation, and lab investigations.

• Good working knowledge of HPLC and GC techniques and trouble shooting skills.

• Ability to multi-task, focus on priorities, and problem solving.

• Ability to work effectively within an interdisciplinary team setting (independently and collaboratively).

• Good knowledge of GMP Compliance, ICH, EP / USP Guidelines.

• Excellent computer skills (Excel, Word, PowerPoint etc.), documentation and technique writing skills.

• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

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.

• Work in a lab and office environment.

• The employee is required to safely handle, use, and dispose of chemicals.

Expected Salary Range:

$89,100-$95,000

The salary range, displayed 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 candidates 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:
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal ( eeoc.gov )
• Employee Polygraph Protection Act:

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