Scientist IV

Description

Summary of the Position

This is a non-supervisory, technical position in USPs 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 collecting data, building chemometric models, and integrating process analytical technologies (PAT) at the bench scale to monitor and characterize continuous flow processes. The incumbent may execute 60% - 80% of their work at the bench level. They direct, troubleshoot, and share 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 test methods and workflows for ensuring compliant, robust API continuous process.
• Develop and validate analytical methods through collaboration with external science partners to develop at-line and in-line PAT methods and models for assessing the quality of batch and continuous manufacturing processes.
• Provide analytical support to process development groups.
• Perform analysis using a variety of analytical methods such as spectroscopy, chromatography, and mass spectrometry.
• Perform peer-reviews of analytical data and reports.
• Write final reports and prepare slides for presentations.
• Use existing databases to document project progresses, track and report the status of assignments to management on a regular basis.
• Work with cross-functional teams within the organization to solve both technical and process-related issues.
• Demonstrate strong technical skill and expertise in specific laboratory methods and troubleshoot instrumentation within area of expertise.
• Seek out innovative ways to apply knowledge or skills to improve protocols and results.
• Actively engage in overall project and ensure own work is aligned with overarching goals.
• Share technical expertise with other lab staff and serves as a mentor for them.
• Serve as technical expert and champion for PAT and/or process model building.
• Recommend and implement new approaches or processes to improve laboratory operations.
• Assist lab head in planning, implementing, and evaluating laboratory procedures/systems.
• Attend scientific seminars and conferences and make presentations.
• Help in establishing Quality systems in the laboratory.
• Lead or assist in technology transfer activities.
• Other duties as assigned.

Basic Qualifications

• Scientist IV: Ph.D. in chemistry or related field with two (2) years of relevant laboratory experience, or an MS in chemistry or related field with six (6) years of experience or a BS in chemistry or related field with eight (8) years of experience
• Sr. Scientist I: Ph.D. in chemistry or related field with five (5) years of relevant laboratory experience, or an MS in chemistry or related field with seven (7) years of experience or a BS in chemistry or related field with ten (10) years of experience
• An equivalent combination of education and experience may substitute.
• Experience in method development and method implementation
• 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 process analytical technology, chemometrics, and knowledge of in-line process analytical tools.

Preferred Qualifications

• Experience with a wide variety of software and laboratory information systems, including chemometric modeling software
• Pharmaceutical laboratory experience, method development and method implementation in manufacturing environments, and/or continuous manufacturing experience.
• Hands-on experience with and willingness to operate a wide range of analytical instrumentation including, but not limited to HPLC, GC, MS, FTIR spectroscopy, NIR spectroscopy Raman spectroscopy, and associated software.
• Working knowledge in analytical methods development and validation requirements.
• Working knowledge of API manufacturing and 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.

Supervisory Responsibilities

N/A

Benefits

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.

About USP

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.

The following COVID-19 provisions will apply to selected candidate(s) hired:

As a condition of employment with United States Pharmacopeial Conventions (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)

Job Category Technical Programs

Job Type Full-Time