Summary
Provides subject matter expertise on all topics Analytical Sciences. Provides scientific and technical leadership in identification, selection and implementation of analytical techniques that may be suitable for the portfolio of projects. Develops and oversees strategies for development, verification, optimization, transfer, and validation of stage appropriate analytical methods. Drafts and reviews scientific documents that are commensurate with the requirement of global regulatory authorities e.g., US FDA, EMA, MHRA. Oversees conduct of 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) following cGMPs. Leads 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 cGMPs, Transpire Bio EH&S and other relevant guidelines. Leads development of extractables and leachables (E&L) analytical methods in support of product development. Leads the development and evaluation of new physico-chemical characterization and aerosol analytical technologies where required. Analyzes and summarizes analytical data using advanced tools including statistical packages. Initiates investigations and data reviews. Coaches, mentors and trains team members. Drafts sections of regulatory dossiers. Communicates data summaries, study observations and recommendations to Executive Management.
Essential Duties and Responsibilities
- Provide subject matter expertise on all topics Analytical Sciences.
- Provide scientific and technical leadership in identification, selection and implementation of analytical techniques.
- Independently design, conduct, lead and supervise liquid chromatography (LC), spectroscopy, and aerosol performance characterization studies for orally inhaled and nasal drug products (OINDP).
- 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 cGMPs, EH&S and other relevant guidelines of Transpire Bio, US FDA and other governing bodies.
- Leads development of extractables and leachables (E&L) analytical methods in support of product development at contract organizations.
- Oversee conduct of standard and advanced laboratory activities.
- Conduct in-depth data analysis including advanced techniques including statistical packages, identify trends and make recommendations, on a routine basis.
- Draft high-quality protocols, methods, reports, standard operation procedures, and submission documents, on a routine basis.
- Supervise and lead the execution of analytical activities required for regulatory submission including method development, verification, optimization, transfer and validation protocols of analytical methods. Participate in laboratory activities as required.
- Present data analysis, recommendations, and conclusions to senior management on a regular basis.
- Lead project analytical 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.
- 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.
- 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.
- Expert knowledge of analytical chemistry methodologies (UPLC/HPLC, GC, UV, FTIR etc.) and aerosol characterization methodologies (Cascade Impaction, Laser Diffraction techniques etc.).
- Expert knowledge of method verification and validation concepts.
- Advanced knowledge of extractables and leachables (E&L) concepts.
- Advanced knowledge of data analysis tools including statistical packages.
- Advanced knowledge and experience in drafting dossier supportive documents and sections of regulatory dossiers.
- Relevant experience in characterization of orally inhaled and nasal drug products OINDPs is a plus.
- Experience in planning and organization.
- Advanced knowledge of FDA cGMP requirements as they apply to the Pharmaceutical industry, USP methodologies and ICH guidelines.
- Strong English language skills including writing ability and oral communication.
- Advanced ability to utilize MS Office communication tools for scientific and management communications.
