Senior Manager - Synthetic Chemistry and API Manufacturing

Position: Senior Manager - Synthetic Chemistry and API Manufacturing

Description

The Senior Manager will serve as a manager for the synthetic chemistry and API manufacturing group. The position is responsible for overseeing the laboratory, equipment, and staff. Additionally, the individual in this role will serve as a subject matter expert in the field of synthetic chemistry, with a focus on process chemistry, including the development, optimization, and scale-up of small molecule Active Pharmaceutical Ingredient (API) synthesis as well as cGMP (current Good Manufacturing Practices) manufacturing in compliance with 21 CFR Parts 210 and 211. This role involves close collaboration with cross-functional teams such as analytical development and quality assurance to ensure successful API production for use in early phase clinical studies. The senior manager role is expected to provide technical leadership, mentorship, and actively engage in securing new project work. They may also serve as primary contacts for clients and represent MRIGlobal as technical experts.

Nature and Scope

• Location: On-site at MRIGlobal's laboratories in Kansas City, Missouri.
• Business Unit: Integrated Pharmaceutical Solutions - Synthesis and API Manufacturing Group
• Reporting To: Assistant Director and operationally to Program Managers and Principal Investigators
• Team: This position entails working with interdisciplinary teams both within MRIGlobal and externally, including but not limited to pharmaceutical analysis, repository management, Facilities, Purchasing, and Quality Assurance, as well as government Contracting Officer Representatives (COR), consultants, and API development teams.

Essential Functions

Management

• Team Management - Responsible for the overall direction and management of the daily operations and scientific laboratory management of the group and stands in for Business Unit leadership when needed. Ensures the quality of the technical work product delivered during project execution.
• Provides facilities management, laboratory equipment supervision and training, and coordination of laboratory management for the Business Unit
• Maintains key assets and stays current with leading edge science/technology in market segments that support core competency areas and significant business development opportunities.
• Assists in development of procedures within the Business Unit to ensure adherence to standards of ethical business conduct and technical work requirements. Takes appropriate actions to correct deficiencies. Provides a safe work environment for each staff member by ensuring that safe working procedures exist, and practices are enforced.
• Involved in aspects of laboratory GMP compliance including equipment maintenance and qualification, building maintenance/upkeep and coordination of all laboratory and safety training and compliance

Subject Matter Expertise

• Lead the design, development, and optimization of API synthesis processes from lab scale (milligram to grams) to early phase manufacturing scale (multi-kilogram scale)
• Solid organic synthesis knowledge and understanding of the fundamental aspects of complex chemistries and processes.
• Considerable hands-on experience with route selection, process development, validation, and technical transfer is required.
• Proven ability and desire to solve technically complex problems.
• Knowledgeable in phase appropriate cGMP and FDA guidelines, including 21 CFR 210/211, FDA Q7, relevant ICH guidelines, and various pharmacopeias (USP, EP)
• May perform direct laboratory operations in execution of a manufacturing batch record under GMP or non-GMP conditions as needed
• Experience/familiarity with analytical techniques such as IR, MS, NMR, and U/HPLC
• Familiar with DOE and QbD techniques to create optimal API manufacturing processes
• Prepare Chemistry, Manufacturing, and Control (CMC) documentation for Investigational New Drug (IND) filings.
• Serve as a Principal Investigator (PI), Task Lead, or Study Director to plan and oversee significant tasks and projects.

Success Factors

• The ability to make sound decisions even in the absence of complete information and has a strategic mindset.
• Ability to drive vision & purpose and drives engagement among managed staff.
• Cultivates innovation and introduces new ways to look at problems. Looks for opportunities to publish and patent work, where applicable and encourages and mentors his/her staff to do the same.
• Excellent interpersonal and leadership qualities.
• High attention to detail, especially in documentation.
• Ability to thrive in a fast-paced, dynamic setting.
• Exceptional communication skills, both oral and written.
• Ability to convey technical details to non-specialists both within MRIGlobal and among clients.
• Strong expertise and experience in synthetic organic chemistry and process optimization.
• Demonstrated experience in process chemistry and cGMP drug substance manufacturing
• In-depth understanding of cGMP regulations and FDA requirements.
• Proficiency in drafting protocols, SOP, test plans, and batch records.
• Proven leadership and problem-solving capabilities.

Qualifications

• PhD in Chemistry, Pharmaceutical Sciences, or a related field with a minimum of 8 years of relevant experience.

Physical Demands and Work Environment Requirements

• Physical Demands: Ability to lift up to 25 pounds, stand for extended periods, and operate laboratory equipment.
• Work Environment: Laboratory setting with potential exposure to hazardous chemicals. Proper PPE must be worn.
• Travel Requirements: Occasional travel may be required for training, conferences, or collaborations with external partners.

General

• This is a full-time position requiring commitment and adaptability to meet departmental goals and deadlines. The Senior Manager is expected to uphold the highest standards of safety and compliance while fostering a culture of innovation and excellence.
• We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.