This is a non-supervisory, technical position in USP’s Manufacturing Services Department. In this role, the incumbent is responsible for developing analytical methods and analytical troubleshooting to support process chemistry development, mainly in continuous operations for active pharmaceutical ingredients (APIs). This work includes integrating the process analytical technologies (PAT) to monitor and characterize continuous flow processes. The incumbent may execute 60% - 80% of their work at the bench level. He/She directs, troubleshoots, and shares insights on complex projects while drawing independent conclusions about the results and determining how to proceed with the project. They closely collaborate with other scientists and/or other USP personnel.
Roles and Responsibilities
- Work with a group of innovative scientists to support continuous process development activities for APIs, as well as analytical troubleshooting.
- Interact closely with external partners of our manufacturing network in identifying, implementing, and troubleshooting laboratory test methods and workflows as well as material for ensuring compliant, robust API continuous process.
- Develop and validate analytical methods through collaboration with external science partners to develop routine methods for assessing the quality of batch and continuous manufacturing processes.
- Provide analytical support to process development groups.
- Performs analysis using a variety of analytical methods such as HPLC, GC, spectroscopy, and mass spectrometry.
- Performs peer-reviews of analytical data and reports.
- Writes final reports and prepares slides for presentations.
- Uses existing databases to document project progresses, tracks and reports the status of assignments to management on a regular basis.
- Works with cross-functional teams within the organization to solve both technical and process-related issues.
- Demonstrates strong technical skill and expertise in specific laboratory methods and troubleshoots instrumentation within area of expertise.
- Seeks out innovative ways to apply knowledge or skills to improve protocols and results.
- Actively engages overall project and ensures own work to be aligned with overarching goals.
- Shares technical expertise with other lab staff and serves as a mentor for them.
- Recommends and implements new approaches or processes to improve laboratory operations.
- Assists lab head in planning, implementing, and evaluating laboratory procedures/systems.
- Attends scientific seminars and conferences and makes presentations.
- Helps in establishing Quality systems in the laboratory.
- Lead or assist in technology transfer activities.
- Other duties as assigned.
- Ph.D. in chemistry or related field with at least 5 years of experience of relevant laboratory experience; M.S. in chemistry or related field with at least 7 years of experience of relevant laboratory experience, or B.A. /B.S. in chemistry or related discipline with at least 10 years of experience of relevant laboratory experience.
- An equivalent combination of education and experience may substitute.
- Experience in method development and characterization compounds.
- Good technical writing and verbal communication skills are required. Good interpersonal skills and process ability to function in a team-oriented environment are necessary.
- Understanding of continuous manufacturing, process analytical technology, and GMP are required, including knowledge of in-line process analytical tools.
- Experience with a wide variety of software and information systems.
- Pharmaceutical laboratory experience and/or continuous manufacturing.
- Extensive hands-on experience with a wide range of analytical instrumentation including, but not limited to HPLC, GC, SFC, MS, Raman spectroscopy, other analytical instrumentation, and associated software.
- Working knowledge in analytical methods development and validation under cGMP environment
- Working knowledge of API development, CMC regulatory requirements, finished product testing and capacity to collaborate in a cross-functional group.
- Strong project management skills with ability to be effective both independently and in collaborative teams.
USP offers an impressive benefits package, including:
- Generous paid time off – 15 paid holidays, 10 sick days and 15 vacation days per year to start
- An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
- Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles.
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
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