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.