Job Title: Associate Director to Director, Analytical, Physicochemical & Aerosol Analysis OINDPs
Job Level:
Location: Weston, FL (near Miami, FL and Fort Lauderdale, FL)
Function: R&D, Product Development
Reports to: Chief Scientific Officer (CSO)
Job Specific Information
Summary
Manages a team of laboratory scientists conducting standard and advanced laboratory activities. Independently designs, conducts, leads, supervises and troubleshoots, physico-chemical characterization studies with a focus on liquid chromatography (LC), spectroscopy, and aerosol performance techniques for orally inhaled and nasal drug products (OINDP). 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 physico-chemical characterization and aerosol analytical technologies where required. Initiates investigations and data reviews. Manages resources and assures progress of project activities on a daily basis. Coaches, mentors and trains team members. 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 liquid chromatography (LC), spectroscopy, and aerosol performance 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 physico-chemical 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 development, verification, transfer and validation protocols 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 across all groups.
- 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 per organization policies. Conduct quarterly performance reviews of group members and provide them with regular feedback. Support the personal development of group members.
- Influence decisions within team.
- 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 / Chemistry / Pharmaceutics/ Pharmaceutical Technology or related fields with a minimum of 12 – 15 years of relevant experience; Minimum 17 – 20 years’ experience in pharmaceutical technology or related fields without a Ph.D.
- In depth knowledge of pharmaceutical and inhalation technology.
- Relevant experience in characterization of orally inhaled and nasal drug products OINDPs.
- Extensive knowledge of analytical chemistry methodologies (UPLC/HPLC, GC, UV, FTIR etc.) and aerosol characterization methodologies (Cascade Impaction, Laser Diffraction techniques etc.).
- Experience in supervising 6-10 laboratory scientists.
- Experience in planning, organization and project management.
- Knowledge and detailed understanding of the FDA cGMP requirements as they apply to the Pharmaceutical industry. Good understanding of USP methodologies and ICH
- 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 a good to have.