You will manage a team of Analytical Scientists and oversee all method development, method validation, and method transfer work.
Provide subject matter expertise on all Analytical Sciences topics.
Lead scientific and technical efforts in identifying, selecting, and implementing analytical techniques suitable for various projects.
Develop and oversee strategies for developing, verifying, optimizing, transferring, and validating stage-appropriate analytical methods.
Draft and review scientific documents for global regulatory authorities (e.g., US FDA, EMA, MHRA).
Oversee standard and advanced laboratory activities.
Independently design, conduct, lead, supervise, and troubleshoot physicochemical characterization studies, focusing on liquid chromatography (LC), spectroscopy, and aerosol performance techniques for orally inhaled and nasal drug products (OINDP) following cGMPs.
Lead the evaluation and selection of raw materials (APIs, excipients, packaging materials, device components), pre-formulation, formulation, and process development studies for OINDPs, adhering to cGMPs, EH&S, and relevant guidelines.
Lead the development and evaluation of new physicochemical characterization and aerosol analytical technologies when needed.
Analyze and summarize analytical data using advanced tools, including statistical packages.
Initiate investigations and conduct data reviews.
Coach, mentor, and train team members.
Draft sections of regulatory dossiers.
Communicate data summaries, study observations, and recommendations to Executive Management.
Duties and Responsibilities:
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 physicochemical and aerosol analytical characterization methodologies for OINDPs.
Lead characterization studies for evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging materials, device components); pre-formulation, formulation, and process development studies for OINDPs following cGMPs, EH&S, and other relevant guidelines.
Lead the development of extractables and leachables (E&L) analytical methods to support product development at contract organizations.
Oversee the conduct of standard and advanced laboratory activities.
Conduct in-depth data analysis, identify trends, and make recommendations using advanced techniques, including statistical packages.
Draft high-quality protocols, methods, reports, standard operating procedures, and submission documents routinely.
Supervise and lead analytical activities required for regulatory submission, including method development, verification, optimization, transfer, and validation protocols.
Participate in laboratory activities as required.
Present data analysis, recommendations, and conclusions to senior management regularly.
Lead analytical activities, support project timelines, and proactively contribute to team objectives.
Communicate effectively with team members and internal/external customers, and collaborate 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 to increase efficiencies and quality of laboratory activities, driving continuous improvement.
Develop and implement appropriate training programs for analytical activities across all groups.
Mentor and assist junior scientists.
Ensure group members are trained on relevant methods, policies, and procedures.
Influence decisions within the team.
Establish and maintain effective relationships with team members.
Ensure lab work is conducted following SOPs and safety rules and procedures.
Comply with all corporate guidelines and policies.
Requirements and Qualifications:
Ph.D. in Analytical Chemistry, Chemistry, Pharmaceutics, Pharmaceutical Technology, or related fields with a minimum of 12-15 years of relevant experience or a minimum of 17-20 years of 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).
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 characterizing orally inhaled and nasal drug products (OINDPs)
Experience in planning and organization.
Advanced knowledge of FDA cGMP requirements, USP methodologies, and ICH guidelines as they apply to the pharmaceutical industry.
Strong written and verbal communication skills
Able to utilize Microsoft Office communication tools for scientific and management communications
Desired Skills and Experience
Analytical Development, Analytical Chemistry, pharmaceutical, UPLC/HPLC, GC, UV, FTIR, aerosol characterization, liquid chromatography, Cascade Impaction, Laser Diffraction, extractables and leachables, OINDPs, nasal drug products, physicochemical characterization, FDA, cGMP, USP methodologies, ICH guidelines, Microsoft Office
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