What are the responsibilities and job description for the R&d Scientist position at Actalent?
SUPERVISORY RESPONSIBILITIES:
1. Organizes, directs, and oversees the schedules and work of Quality Control Scientists and Technicians.
2. Provide opportunities for on-the-job training and SOP review as necessary.
3. Collaborate with other managers and supervisors to coordinate activities in and among departments
TRAVEL:
This position requires some travel, up to 25%.
DUTIES/RESPONSIBILIITIES:
Quality Control Lab:
1. Responsible for ordering and maintaining laboratory supplies to ensure smooth operations in the laboratory.
2. Ensure timely release testing on all incoming raw materials and finished goods
3. Schedule and perform maintenance and calibration of all equipment as needed.
4. Cross train to be able to adequately and accurately perform other lab and sample lab duties.
5. Review SOP’s as needed to update to current procedures.
6. Create and write protocols for incoming method developments.
7. Ensure compliance to ensure a safe work environment.
8. Ensure compliance with Federal, state, local, FDA, cGMPs organizational laws, regulations, guidelines, and best practices.
9. Compile Chemistry, Manufacturing, and Controls (CMC) documentation as needed for submissions to FDA.
10. Review CMC submissions.
11. Compile manufacturing and change control documentation for the minor changes and stability reports (MCSRs) submitted annually to the FDA.
Research & Development:
1. Work independently to find and develop methods for new project development.
2. Perform method validations.
3. Conduct R&D experiments as directed by the Director of Quality Control & R&D.
Internal and External Audit:
1. Conduct routine audits of internal and external operations to ensure compliance with cGMPs, SOP’s and safety regulations.
2. Collect, review and analyze processes and procedures for internal and external manufacturing, warehouse, and laboratory activities.
3. Identify discrepancies, risks and other problems and report findings to upper management with recommendations for appropriate corrective measures.
4. Evaluate compliance of internal and external systems.
5. Responsible for follow-up of implementation of agreed upon improvements as the result of audit findings.
Additional Skills & Qualifications:
1. Bachelor degree of Science in Chemistry, Microbiology or Biology.
2. Working knowledge of scientific instrumentation and techniques.
3. Working knowledge of Regulatory, cGMP, and FDA regulations as required to ensure products and production units meet quality standards.
4. Proficient computer knowledge including but not limited to basic spreadsheet functions and word processing.
5. 2-4 years Audit experience, preferably in a pharmaceutical facility.
6. 2-4 years supervisory experience.
7. Valid driver’s license and ability to operate a vehicle
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
