Analytical Manager, Pharmaceutical Product Development

Job Summary

Manages a team of laboratory scientists conducting standard and advanced laboratory activities. Independently designs, conducts, leads and supervises characterization studies for orally inhaled and nasal drug products (OINDP) with a focus on pharmaceutical performance analytical technologies. Supports evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development studies for OINDPs following cGMP, Transpire Bio EH&S and other relevant guidelines. Leads the development and evaluation of new aerosol analytical technologies where required. Initiates investigations and data reviews. Manages resources and assure progress of project activities on a daily basis. Coaches, mentors and trains team members. Plan laboratory activities and resources on a weekly basis and ensure that project timelines are met consistently. Communicates data summaries, study observations and recommendations to Executive Management.

Essential Duties and 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 (OINDP).
• Provide leadership in CMC activities and represent CMC on global project teams.
• Act as subject matter expert (SME) on pharmaceutical performance and aerosol analytical characterization methodologies for OINDPs.
• Lead characterization studies for evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development studies for OINDPs following cGMP, EH&S and other relevant guidelines of Transpire Bio, FDA and other governing bodies.
• Supervise and lead the execution of analytical activities required for regulatory submission including method transfer protocols and validation of analytical methods. Participate in laboratory activities as required.
• Write protocols, methods, reports, standard operation procedures, and submission documents when required.
• Analyze data, identify trends and perform statistical analysis. Present data, recommendations and conclusions to senior management on a regular basis.
• Lead project activities, support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with team members and internal or external customers. Work and communicate effectively with other functional groups.
• Troubleshoot technical issues, analyze data, identify solutions, and implement recommendations.
• Plan laboratory activities and resources on a weekly basis and ensure that project timelines are met consistently.
• Develop and communicate project plans, goals and strategies to the group.
• Propose and implement processes and new technologies that lead to increased efficiencies and quality of laboratory activities. Drive the continuous improvement process.
• Develop and implement appropriate training programs for analytical activities.
• Mentor and assist junior scientists.
• Ensure that members of the group are trained on relevant methods, policies and procedures. Verify that training records of group members are updated on a regular basis. Conduct quarterly performance reviews of group members and provide them with regular feedback. Support the personal development of group members.
• Establish and maintain effective relationships with team members.
• Ensure lab work is conducted in accordance with SOPs; follow Transpire Bio safety rules and procedures.
• Comply with all Transpire Bio Corporate guidelines and policies.

Qualification Requirements

• Ph.D. in Analytical Chemistry/Pharmaceutics/Pharmaceutical Technology/Pharmaceutical Chemistry or related fields with a minimum 7 years of relevant experience; Minimum 11 years’ experience in pharmaceutical technology or related fields without a Ph.D.
• In depth knowledge of pharmaceutical product development principles.
• Relevant experience in characterization of orally inhaled and nasal drug products OINDPs is a plus.
• Expertise in analytical chemistry methodologies (HPLC, GC, UV, FTIR etc.).
• Working knowledge of pharmaceutical performance and aerosol characterization methodologies (Cascade Impaction, Laser Diffraction techniques etc.).
• Expert level understanding of the FDA cGMP requirements as they apply to the biopharmaceutical industry.
• Expert level understanding of USP methodologies and ICH guidelines.
• Demonstrated experience in supervising 6-10 laboratory scientists over past 3+ years is a must to have.
• Experience in planning, organization and project management.
• Strong English language skills including writing ability and oral communication.
• Advanced ability to utilize MS Office communication tools for scientific and management communications.
• Ability to utilize statistical data packages for data processing and communication is good to have.