The role involves overseeing analytical services projects, ensuring timely completion in alignment with cGMP quality systems, and streamlining operations to meet business targets. Key duties include supporting business development through client interactions, proposal writing, and representing AMPAC Analytical at conferences. The candidate will guide documentation processes, conduct independent investigations with advanced chemistry principles, and serve as an SME on complex analytical techniques. Additionally, they will mentor team members, lead analytical audits, and drive continuous improvement activities across multiple functional departments.
Duties and Responsibilities
Collaborate with Functional Department Leads, Analytical Team Leads, and senior scientists to assign and prioritize projects. Oversee all analytical services activities, ensuring timely completion in accordance with cGMP quality systems. Manage business milestones, identify and escalate at-risk milestones using tools like Gantt charts and risk assessments, and drive remediation. Review and maintain business targets, streamlining operations to meet goals.
Support business development by participating in client meetings, writing proposals, and handling change orders. Represent AMPAC Analytical at conferences and client meetings, answering technical questions and developing long-term relationships. Collaborate in customer meetings with other project leaders, ensuring clear and concise communication.
Guide and author key documentation, including protocols, procedures, and reports. Review and approve final reports for all processes and procedures. Lead changes in documentation and systems through the change control process, including revisions, justifications, risk assessments, and tracking approvals. Write analytical CMC sections for regulatory filings, ensuring compliance with ICH, regional, scientific, and company requirements.
Conduct independent investigations using advanced chemistry principles and analytical equipment. Serve as an SME on complex analytical techniques at AMPAC. Continuously study and stay current with cGMP standards and industry trends, identifying potential areas for expansion.
Serve as a mentor for quality control and analytical team members, providing technical guidance on analytical technologies and troubleshooting.
Involved in leading analytical audits across multiple AFC sites.
Lead continuous improvement activities across multiple functional departments at AFC and contribute to large-scale organizational updates impacting the analytical department.
EDUCATION AND EXPERIENCE
Bachelor's degree of science in chemistry or an appropriate science with relevant experience
7-9 years of directly related technical experience in chemistry
COMPETENCIES/SKILLS
Ability to communicate clearly and concisely both orally and in writing.
Good understanding and experience of chemical laboratory process and equipment, specialized analytical equipment, and various computer systems.
Subject matter expert (SME) in an advanced analytical technique.
Must be proficient with the use of general laboratory software and CDS systems.
Must be proficient with the use of HPLC, GC, NMR, IC, HSGC and mass spectrometry (including various applications of these techniques), in addition to other simpler analytical procedures.
Must have knowledge of cGMP related to the analytical testing and development of analytical methods for an API manufacturer.
Understand and use process and analytical equipment pertinent to the appropriate application of skills.
CERTIFICATIONS and LICENSES
Not Applicable
This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time.
