Job ID: 7601
Job Title: Director Analytical Chemistry
Location: Richmond, VA
Senior Director, Analytical Chemistry, MS&T
Job Description
Location: Richmond, VA
To apply: please visit
The purpose of this role is to provide leadership and, at times, Subject Matter Expertise (SME) in the area of analytical chemistry to support API development and manufacturing. The Senior Director, Analytical Chemistry will support internal businesses to ensure business objectives are met. Serve as the technical leader for or supervisor to the technical leader on API development projects and oversee and manage strategic partners. The candidate will ensure excellence of our analytical method development and technical transfers to or within and interact with other internal and external departments (EH&S, Engineering, Program Management, Quality Assurance, Regulatory Affairs) as required. The candidate will personify shared values and culture, both internally and externally. The candidate will work with the highest standards of safety, integrity, transparency, and ethics to create win-win scenarios for patients, customers, partners, and colleagues.
Responsibilities:
- Direct and oversee all aspects of analytical method development, method validations and method transfer activities to support API development projects, especially in pharmaceutical continuous processes using Process Analytical Technologies (PAT)
- Collaborate with cross-functional teams, including process R&D, Quality, Regulatory, Supply Chain, and Operations to ensure alignment and seamless execution of technical project initiatives
- Lead or manage technical direction of analytical projects; identify key deliverables and next steps and communicate to the team
- Lead or manage CMO/CRO analytical project resources, such as contractors and contract laboratories, as needed
- Ensure excellence in data review, analysis, and interpretation from a variety of sources. Provide accurate summaries and make recommendations to stakeholders with scientific rigor.
- Ensure excellence in identifying and implementing new techniques and instrumentation to expand internal capabilities and leads continuous improvements
- Ensure excellence in authoring and reviewing technical reports, regulatory submissions, SOPs, validation protocols, and other cGMP documents
- Lead or manage day-to-day laboratory activities for analytical equipment, including sourcing consumables, troubleshooting, maintaining equipment and calibrations with various vendors
- Develop and mentor staff
Qualifications:
- Minimum of 15 years years of relevant analytical chemistry management and leadership experience within the Pharmaceutical or Contract Development and Manufacturing industry
- Strong track record of success including analytical method development that supports process development and manufacturing
- Strong track record in analytical method transfers, and continuous improvement
- Excellent interpersonal and communication skills
- Experience in working in a multi-disciplinary team environment
- Demonstrated ability to lead, mentor, influence, collaborate, and work with individuals, colleagues and clients
Preferred Qualifications:
- D. with a minimum 15 years of experience, M.S with a minimum 20 years of experience, or B.S. degree with a minimum 25 years of experience in Analytical Chemistry, Pharmaceutical Sciences, or a related scientific field
- Experience with the development and implementation of Process Analytical Technology (PAT)
- Demonstrated experience with generic API development, technology transfer, and manufacture
- Strong knowledge of the drug development process, ICH requirements, and current Good Manufacturing Practices (cGMP)
- Excellent analytical and problem-solving skills with ability to prioritize tasks according to business objectives and manage multiple programs within defined timelines and budgets
- Experience working for a contract organization (CROs/CMOs/CDMOs)
- Experience managing third-party vendors (CROs/CMOs/CDMOs)
- Knowledge of chemistry-related CMC sections of IND/IMPD and NDA/MAA regulatory submissions
- A track record of speaking at conferences and publishing in peer reviewed journals
- Experience authoring or contributing to regulatory submissions (NDAs/ANDAs/DMFs)
