Currently looking for a Supervisor, Analytical Chemistry to fill an opening with a company located in Copiague, NY. Interested candidates must hold a Bachelor’s degree in Chemistry (PhD preferred) and have a minimum of 5 years of experience in GMP pharma operations, previous laboratory work in the analytical units or R&D in pharmaceutical or related industry.
The Supervisor - Analytical Chemistry is a member of the Quality Analytical Services (QAS) organization, and is responsible for providing analytical leadership to manufacturing, operations, and quality organization. The Supervisor will supervise a group of 3-4 scientists and contribute skills and effort to laboratory work. The scope of work will include hands on laboratory work and will also include product problem solving and troubleshooting, strategy/test plan development, analytical method remediation activities, and impurity isolation/identification for a broad range of materials and product types.
The Supervisor - Analytical Chemistry works under the direction of the Director.
Responsibilities of the Supervisor, Analytical Chemistry:
1. The Supervisor will lead the efforts of the analytical chemistry laboratory and supervise 3-4 additional staff. Must actively contribute to laboratory productivity.
2. Provide analytical chemical testing/laboratory work in support of the department for commercial product support, product testing, degradation profiles, impurity identification, extractable leachable testing, and material contact studies. Material scope includes but is not limited to raw material, API, in process testing and finished drug product testing of the product forms noted in the company summary.
3. In coordination with other QAS personnel, design investigations to support commercial product troubleshooting and execute well designed lab experiments.
4. Troubleshoot and remediate analytical test methods for a wide range of API, excipients and finished products.
5. Design and execute test method development.
6. In support of capital plan, install, qualify and maintain the required laboratory equipment within QAS laboratory.
7. Knowledgeable in the Transfer of Analytical Procedures. Perform analytical laboratory work to serve as the sending lab for test method transfer, as needed within all company sites, contract manufacturing facilities and contract laboratories.
8. Organize, review and approve work of others.
9. Document and maintain data/test results per GMP, produce protocols and reports; present results as required for management updates.
10. Operate and maintain the QAS laboratory within GMP and SOP requirements and within budget.
11. Perform other duties as deemed necessary by department management.
1. Ensure that all data comply with cGMP, FDA and/or other appropriate regulatory guidelines.
2. Work cooperatively with other QAS staff and other departments throughout the company.
Requirements of the Supervisor, Analytical Chemistry:
1. BS in Chemistry with 5+ years of experience, PhD preferred.
2. Direct experience in GMP pharma operations. Previous laboratory work in the analytical units or R&D in pharmaceutical or related industry.
3. Experience supervising others.
4. Strong project management and organizational skills, prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules efficiently; and develops realistic plans.
5. Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan.
6. Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure high quality.
1. Demonstrated thorough working knowledge of chemical analysis and complex problem solving.
2. Hands on laboratory experience required to troubleshoot projects.
3. Knowledge of US FDA GMP guidelines.
4. A working knowledge of pharmaceutical product development and US FDA filing requirements for packaging is beneficial.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required.
1. The individual must have demonstrated thorough working knowledge of chemical analysis, including UP/HPLC, GC, prep HPLC, LCMS, tablet/suspension dissolution. The individual must also have a fundamental understanding of algebra and statistics.
2. The individual must have strong verbal communication and writing skills in English.
3. The individual must have the ability to comprehend complex instructions and tasks and have strong analytical and logical problem solving abilities.
4. Some synthetic organic experience is desired.
5. The individual must have strong project management skills.
6. The individual must have the ability to excel in a cross-functional working environment and the ability to multi-task, prioritize and handle multiple projects at once.
7. The individual needs to be able to collaborate with other teams, as well as maintain and strengthen cross departmental relationships.