Analytical Manager, Pharmaceutical Product Development

Transpire BIO Inc. • Sunrise, FL

8d

About The Position

The Analytical Manager, Pharmaceutical Product Development manages a team of laboratory scientists and oversees standard and advanced laboratory activities. The role independently designs, conducts, leads, and supervises characterization studies for orally inhaled and nasal drug products (OINDPs), with a focus on pharmaceutical performance analytical technologies. It supports the evaluation and selection of raw materials, including APIs, excipients, packaging materials, and device component materials, as well as pre-formulation, formulation, and process development studies in accordance with cGMP, Transpire Bio EH&S requirements, and other relevant guidelines.

The manager serves as a subject matter expert in pharmaceutical performance and aerosol analytical characterization methodologies, leads CMC activities, and represents CMC on global project teams. The position oversees analytical activities for regulatory submissions, including method transfers and analytical method validation, and prepares or contributes to protocols, methods, reports, SOPs, and submission documents. It analyzes and presents data, trends, recommendations, and conclusions to senior and executive management.

The role manages project activities, laboratory resources, and timelines; develops project plans and strategies; troubleshoots technical issues; and drives process improvements and adoption of new technologies. It also trains, coaches, and mentors team members, maintains training records, conducts quarterly performance reviews, and supports staff development. The manager ensures laboratory work follows SOPs and safety procedures and complies with corporate policies.

Requirements

• Ph.D. in Analytical Chemistry, Pharmaceutics, Pharmaceutical Technology, Pharmaceutical Chemistry, or a related field, with at least 7 years of relevant experience; alternatively, at least 11 years of experience in pharmaceutical technology or a related field without a Ph.D.
• In-depth knowledge of pharmaceutical product development principles.
• Expertise in analytical chemistry methodologies, including HPLC, GC, UV, and FTIR.
• Working knowledge of pharmaceutical performance and aerosol characterization methodologies, including cascade impaction and laser diffraction techniques.
• Expert-level understanding of FDA cGMP requirements as they apply to the biopharmaceutical industry.
• Expert-level understanding of USP methodologies and ICH guidelines.
• At least 3 years of demonstrated experience supervising 6–10 laboratory scientists.
• Experience in planning, organization, and project management.
• Strong English-language skills, including writing and oral communication.
• Advanced ability to use MS Office communication tools for scientific and management communications.

Nice To Haves

• Relevant experience characterizing orally inhaled and nasal drug products (OINDPs).
• Ability to use statistical data packages for data processing and communication.

Responsibilities

• Manage a group of laboratory scientists conducting standard and advanced laboratory activities.
• Independently design, conduct, lead, and supervise characterization studies for orally inhaled and nasal drug products (OINDPs).
• Provide leadership in CMC activities and represent CMC on global project teams.
• Serve as a subject matter expert in pharmaceutical performance and aerosol analytical characterization methodologies for OINDPs.
• Lead characterization studies for evaluating and selecting raw materials, including APIs, excipients, packaging materials, and device component materials, and for OINDP pre-formulation, formulation, and process development.
• Supervise and lead analytical activities required for regulatory submissions, including method transfer protocols and analytical method validation; participate in laboratory activities as needed.
• Write protocols, methods, reports, standard operating procedures, and submission documents as required.
• Analyze data, identify trends, perform statistical analyses, and regularly present data, recommendations, and conclusions to senior management.
• Lead project activities, support timelines, contribute to team objectives, and communicate effectively with team members, customers, and other functional groups.
• Troubleshoot technical issues, analyze data, identify solutions, and implement recommendations.
• Plan weekly laboratory activities and resources and ensure project timelines are consistently met.
• Develop and communicate project plans, goals, and strategies to the group.
• Propose and implement processes and technologies that improve laboratory efficiency and quality, and drive continuous improvement.
• Develop and implement training programs for analytical activities.
• Mentor and assist junior scientists.
• Ensure group members are trained on relevant methods, policies, and procedures; keep training records current; conduct quarterly performance reviews; provide regular feedback; and support personal development.
• Establish and maintain effective relationships with team members.
• Ensure laboratory work follows SOPs and Transpire Bio safety rules and procedures.
• Comply with Transpire Bio corporate guidelines and policies.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree