Product Development Manager

Job Level: Mid-Level Manager

Location: Weston, FL — near Miami and Fort Lauderdale

Function: R&D / Pharmaceutical Product Development

Reports to: Senior Director, Analytical Sciences

Schedule: 1st Shift or 2nd Shift available

Compensation: $70–$90 per hour, depending on experience and qualifications The ideal candidate will bring strong analytical chemistry expertise, experience managing a scientific team, knowledge of pharmaceutical development and regulatory requirements, and the ability to effectively communicate technical findings and recommendations to cross-functional teams and senior leadership.

Key Responsibilities: Technical & Scientific Leadership Manage and provide technical leadership to a team of laboratory scientists conducting routine and advanced analytical activities. Design, conduct, lead, and supervise analytical characterization and product development studies. Support CMC activities and participate on cross-functional project teams. Provide technical expertise in analytical chemistry and pharmaceutical product characterization. Support evaluation and selection of APIs, excipients, packaging materials, device components, and other raw materials. Support pre-formulation, formulation, and process development activities. Evaluate and implement new analytical technologies and laboratory approaches where appropriate. Troubleshoot technical issues, interpret analytical data, identify solutions, and implement recommendations. Identify opportunities for continuous improvement in laboratory processes, analytical capabilities, quality, and efficiency. Analytical Development & Regulatory Support Lead or support analytical activities required for regulatory submissions. Support analytical method development, method transfer, qualification, and validation activities. Prepare and review analytical protocols, methods, reports, SOPs, and technical documentation. Analyze data, identify trends, and perform appropriate statistical analysis. Present analytical results, conclusions, and recommendations to project teams and management. Support investigations, data reviews, deviations, and technical assessments as needed. Ensure analytical activities comply with applicable FDA cGMP requirements, USP methodologies, ICH guidelines, and internal procedures. Project & Laboratory Management Plan laboratory activities, staffing, equipment, and resources to support project timelines. Prioritize daily and weekly laboratory activities to ensure milestones are achieved. Develop and communicate project plans, objectives, and strategies. Monitor project progress and proactively identify potential risks or delays. Collaborate effectively with R&D, CMC, Quality, Regulatory, Operations, and other functional groups. Communicate project status, technical findings, and recommendations to management. Promote efficient utilization of laboratory resources and personnel. People Leadership & Development Supervise, coach, mentor, and develop laboratory scientists. Provide technical guidance and support to team members. Establish and maintain appropriate training programs for analytical activities. Ensure team members are appropriately trained on methods, SOPs, policies, and procedures. Maintain accurate and up-to-date training records. Provide regular performance feedback and support employee development. Foster a collaborative, accountable, and high-performing laboratory environment. Quality & Compliance Ensure laboratory activities are performed in accordance with applicable SOPs, cGMP requirements, safety procedures, and company policies. Promote a strong culture of quality, safety, compliance, and data integrity. Ensure appropriate documentation of laboratory activities and analytical results. Support continuous improvement initiatives within the laboratory and broader R&D organization.

Required Qualifications: Ph. D. in Analytical Chemistry, Pharmaceutics, Pharmaceutical Technology, Pharmaceutical Chemistry, or a related field with approximately 7+ years of relevant experience; or Bachelor's or Master's degree in a relevant scientific discipline with approximately 11+ years of relevant pharmaceutical or analytical experience. Demonstrated experience managing, supervising, or leading a team of laboratory scientists. Experience managing approximately 6–10 scientists is strongly preferred. Strong knowledge of pharmaceutical product development and analytical chemistry principles. Hands-on or strong working knowledge of analytical techniques such as: HPLCGCUV/VisFTIROther relevant pharmaceutical analytical methodologies Working knowledge of FDA cGMP requirements applicable to pharmaceutical product development. Knowledge of USP methodologies and ICH guidelines. Experience with analytical method development, transfer, qualification, and/or validation. Strong project planning, organizational, and resource-management skills. Excellent written and verbal communication skills. Proficiency with Microsoft Office and standard scientific/business communication tools.

Preferred Qualifications: Experience with orally inhaled and nasal drug products (OINDPs).Experience with aerosol science, aerosol characterization, cascade impaction, laser diffraction, or related pharmaceutical performance testing. Experience supporting CMC programs and regulatory submissions. Experience implementing new analytical technologies or laboratory processes. Experience with statistical/data-analysis software. Experience working in a multidisciplinary pharmaceutical product development organization. Important: Experience with aerosol science or OINDPs is preferred, not required. APPLY NOW!