Manager, Analytical Chemistry

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

The Manager, Analytical Chemistry, offers the opportunity to play a key part in advancing new drug development and supporting product lifecycle management through strategic leadership and scientific expertise. As Manager, Analytical Chemistry, you'll lead cross-functional collaboration, working closely with project managers to align resources, resolve challenges, and drive timely execution across a diverse portfolio of programs. You'll oversee internal labs and external partners, ensuring high-quality analytical support in compliance with GLP/GMP standards. In addition, you'll lead and mentor a talented team, fostering a collaborative, high-performance culture focused on innovation, continuous improvement, and scientific excellence. This is a highly visible role with meaningful impact across the development pipeline.

Essential Functions

• Maintain deep expertise in analytical and bioanalytical chemistry to support all stages of drug development and commercial product lifecycle management across diverse product categories, including small molecules, oligonucleotides, peptides, biologics, medical devices, and combination products.

• Provide strategic and hands-on expertise in analytical method development, validation, transfer, and bioanalysis for drug development and clinical studies, with proficiency in HPLC/UPLC, LC/MS, GC, GC/MS, ICP/MS, TGA, and FTIR.

• Collaborate effectively in a matrixed organization with cross-functional teams such as Synthetic Chemistry, Formulation, Biology, Operations, Quality, and Clinical Development to meet project milestones and timelines.

• Oversee analytical lab operations, ensuring proper instrumentation, maintenance, documentation, and compliance with business and regulatory requirements.

• Communicate effectively with internal and external stakeholders to optimize resource planning, while managing partnerships with external labs to ensure quality, compliance, and support for routine and overflow work.

• Lead and mentor a high-performing Analytical Chemistry team by assigning personnel based on project priorities, providing coaching and development, setting objectives, and conducting performance reviews to ensure alignment with organizational goals and a culture of accountability.

• Provide leadership in managing, developing, and evaluating team members to ensure the function operates efficiently and effectively Manages.

• Ensure all research personnel meet safety and training requirements in accordance with internal policies and regulatory standards.

• Maintain advanced, up-to-date knowledge of global regulatory requirements, industry best practices, and scientific literature to ensure compliance and inform product development strategies.

• Contribute to regulatory submissions by drafting relevant sections, such as the CMC portions for FDA submissions, CTDs, and other global regulatory dossiers.

Minimum Requirements

• PhD in Chemistry, Biology, Pharmaceutical Science, Physics, or related science with 6+ years of pharmaceutical or related work experience in field.

• MS in Chemistry, Biology, Pharmaceutical Science, Physics, or related science typically with 8+ years of pharmaceutical or related work experience in field.

• BA or BS in Chemistry, Biology, Pharmaceutical Science, Physics, or related science typically with 10+ years of pharmaceutical or related work experience in field.

• 3+ years supervisory experience.

• Expertise in incorporating laboratory automation to enhance efficiency.

• Strong leadership and organizational skills with advanced problem-solving ability, technical competency, and experience in developing high-performing teams.

• Excellent communication skills (oral and written)

Preferred Skills/Qualifications:

• Cross-functional knowledge of analytical methods associated with medicinal chemistry, process chemistry, formulation, biomanufacturing and medical devices

• CRO management knowledge

• Chemical Design for Six Sigma knowledge

Position directly reports to the Senior Director, Global Technical Operations.

This position involves normal office conditions with exposure to research laboratory operations. Occasional travel may be required for engagement with external laboratories and collaborators.

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