The U.S. Pharmacopeial Convention (USP) Senior Manager, AMT Lab Services in Richmond, Virginia
Summary of the Position
The Senior Manager, Advanced Manufacturing Technology (AMT) Laboratory Services position is a key supervisory position in the Manufacturing Services Department, responsible for the oversight and delivery of AMT-related research and analytical services to USP customers. This includes project management, administrative supervision, technical leadership, and training and development of staff. The incumbent in this role will utilize his or her technical expertise, knowledge of the continuous pharmaceutical manufacturing, and strong organizational and communication skills to ensure safe, high-quality, efficient, and effective laboratory operations. The Senior Manager will be responsible for coordinating laboratory project activity with staff and external partners to ensure prompt completion of each project. As a working-manager position, the incumbent is expected to participate in and deliver on projects using up to 50% of the available time. This position is a critical component of USP’s Manufacturing Services solutions aimed at solving scientific challenges for customers using the newest and most advanced pharmaceutical manufacturing techniques.
Roles and Responsibilities
Leads, manages, and directs laboratory team activities in method development and analytical testing on projects utilizing advanced manufacturing technologies, especially pharmaceutical continuous manufacturing and Process Analytical Technologies (PAT).
Prioritizes and coordinates laboratory testing projects across AMT lab.
Monitor and ensure effective completion of critical projects.
Manages laboratory resources with the philosophy of safety, quality, integrity, efficiency, and stewardship.
Sets daily priorities and holds employees accountable for results.
Integrates internal and external best practices to facilitate the delivery of superior results.
Leads continuous improvement innovations via new processes and/or technologies.
Reviews and approves change controls, training documents, calibrations, SOPs, and reports.
Ensures project goals are set and met within timelines.
Works with internal clients, external partners, and customers to manage projects appropriately and to ensure impeccable work-product delivery.
Develops and mentors scientific staff.
Assists in the accomplishment of key statements of work and other project deliverables.
Works with a group of innovative scientists to support continuous process development activities for APIs, as well as analytical troubleshooting.
Interacts closely with external partners of our manufacturing network to identify, implement, and troubleshoot laboratory test methods, workflows, and material while 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.
Leads or assists in technology transfer activities.
Establishes quality systems and train scientific staff on them.
Ph.D. in chemistry or related field with 8 years of relevant laboratory experience; M.S. in chemistry or related field with at least 10 years of relevant laboratory experience
Minimum of 4 years of direct supervisory experience in a laboratory setting.
An equivalent combination of education and experience may substitute.
Experience in method development and characterization of 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.
Takes personal responsibility for delivery of projects to customers.
Demonstrated skills to increase the knowledge, abilities, and contributions of staff.
Strong project management skills with ability to lead collaborative teams.
Experience with a wide variety of software and information systems.
Effective coach and mentor to staff. Has the ability to identify and develop talent.
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.
Hand-on experience in method transfers and associated trouble shooting.
Laboratory staff of up to seven (7) scientists with varying levels of experience.
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.
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 contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Chemistry & Scientific Standards
Job Type Full-Time