: Manager, Analytical Research and Development
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.Location/Division Specific Information
High Point, NC SoftgelsHow will you make an impact?
What will you do?
- A Manager in the Analytical Research and Development (AR&D) is expected to independently manage the activities of a group of analytical chemists and perform all related administrative functions for the group.
- The functions of the group include providing analytical support to internal, and occasionally external, pharmaceutical product development projects.
- Duties include, but are not limited to, cleaning verification, method development, validation, qualification and transfer, stability, raw material, finished product testing and partnering with the Formulation R&D team.
How will you get here? Education
- Ensure that the work performed by direct reports meet pharmaceutical industry and internal company standards for quality and timeliness. Primary duties of direct reports will include the following.
- Develop and validate methods to test pharmaceutical raw materials and finished products for strength, identity, impurities and dissolution performance by commonly used techniques.
- Test and release raw materials and finished products in support of internal product development.
- Test stability samples in support of internal product development.
- Administrate the departmental cleaning verification program to support the Pilot Plant and the packaging lines.
- Plan, review and manage the activities performed by direct reports. Such work must meet all appropriate scientific, regulatory and safety standards, including GMPs, ICH, OSHA and internal SOPs.
- Ensure that all direct reports are properly trained and equipped to perform their assigned duties.
- Accurately, clearly and completely communicate the results of work, orally and/or in writing, to line management, clients and/or others with a need to know.
- Work with other sections and department within the company as needed to facilitate the successful development and launch of new products and technologies and assist in trouble-shooting problems with currently marketed products.
- Represent the Analytical Development group by participating in departmental and company project teams.
- Assist in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.
- Write SOPs and other instructional documents for the Analytical Development group.
- Help enhance capabilities of the analytical group by appropriate investments in capital and personnel.
- Help institute new work processes and initiatives to improve efficiency, workflow and turnaround time.
- Masters or Ph.D. in Chemistry (a focus on Analytical is preferred) with at least 5-6 years of directly related experience, including at least 3-4 years of directly related supervisory experience.
- Other educational qualifications may be considered if accompanied by additional related experience.
Knowledge, Skills, Abilities
- An expert at developing and validating test methods for pharmaceutical raw materials and finished products for strength, impurities, identity and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis.
- An expert at testing pharmaceutical raw materials and finished products by internally developed and compendial test methods.
- An expert at troubleshooting analytical and instrument problems and at performing OOS investigations.
- An expert at GMPs as they pertain to an R&D analytical group and pharmaceutical product development.
- A strong working knowledge of descriptive organic chemistry.
- A working knowledge of pharmaceutical formulations development.
- Will be an experienced technical and personal leader who leads by example.
- Will be expected to direct the activities of the AR&D team.
- Will effectively maintain open communication within the R&D team, as well as external, customers.
- Will possess teaching skills so that knowledge is passed on to the direct reports.
- Will be able to manage a growing group of chemists for high levels of efficiency, quality and safety. Will be able to flexibly manage multiple priorities.
- Will have a strong command of the English language with strong oral and written communication skills.
- Will have a solid working knowledge of, and experience with, common office software and chromatographic data acquisition systems.
- Will have experience in providing support for generating CMC sections of INDs, ANDAs and NDAs (including 505b2).
- Will be able to effectively work in multidisciplinary teams within the department and company.
- This position will report to the site head of Research and Development.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Posting ID: 556644583Posted: 2020-05-21