Product Development lead

Job Description

Job Description

We are seeking an experienced Analytical Manager, Pharmaceutical Product Development to lead a team of laboratory scientists supporting analytical development, characterization, and pharmaceutical product development activities.

This position provides both technical and people leadership within a regulated pharmaceutical R&D environment. The manager will oversee laboratory activities, support analytical development and product characterization, manage project priorities and resources, and mentor a team of scientists.

Job Level: Mid-Level Manager

Location: Near Miami and Fort Lauderdale

Function: R&D / Pharmaceutical Product Development

Reports to: Senior Director, Analytical Sciences

Schedule: 1st Shift or 2nd Shift

Compensation: $70–$90 per hour, depending on experience and qualifications

Key ResponsibilitiesTechnical & 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:
• HPLC
• GC
• UV/Vis
• FTIR
• Other 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.
• Experience with aerosol science or OINDPs is preferred, not required .