What are the responsibilities and job description for the Research and Development Manager position at AP MAX INC?
About Southend Pharmacy
At Southend Pharmacy, we are dedicated to delivering exceptional pharmacy services that uphold the highest standards of compliance, safety, and patient care. As a growing organization, we are seeking a detail-oriented and highly skilled Research and Development Manager to oversee and guide the development of new compounded products while ensuring alignment with business goals and regulatory requirements.
Position Summary
The Research and Development (R&D) Manager will lead the design, development, and optimization of compounded sterile and non-sterile preparations to support patient care and business growth. This role oversees formulation innovation, process improvement, and compliance with regulatory and quality standards. The R&D Manager collaborates with pharmacy operations, quality assurance, and clinical teams to ensure products are safe, effective, and aligned with organizational goals.
Key Responsibilities
Product Development & Innovation
- Lead research and development of new sterile and non-sterile compounded formulations.
- Conduct feasibility studies, literature reviews, and stability testing for new products.
- Identify opportunities for innovation to meet patient, provider, and market needs.
- Regulatory & Compliance
- Ensure all R&D activities comply with USP <795>, <797>, <800>, FDA, DEA, and state board of pharmacy regulations.
- Maintain accurate documentation of formulation trials, testing, and validation processes.
- Support preparation of regulatory submissions and responses to inquiries.
- Collaboration & Leadership
- Coach, support, and supervise team members, ensuring project milestones and deliverables are achieved on time and to quality standards
- Partner with pharmacists, technicians, quality assurance, and operations teams to optimize formulations and processes.
- Train staff on new formulations, compounding techniques, and technology.
Serve as subject matter expert for compounding innovation and technical inquiries.
Quality & Process Optimization
- Oversee analytical testing, stability studies, and data interpretation for new and existing formulations.
- Develop standard operating procedures (SOPs) for R&D activities.
- Drive continuous improvement in product quality, efficiency, and safety.
- Strategic Contributions
- Analyze industry trends, scientific advancements, and competitive landscape to identify new opportunities.
- Provide input into strategic growth initiatives and service expansion.
Collaborate with business development to evaluate commercial viability of new formulations.
Required Qualifications
Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy required; advanced degree in pharmaceutical sciences, chemistry, or related field preferred.
- Board Certification in Sterile Compounding (BCSCP) or equivalent preferred.
- Minimum 5 years of experience in sterile and/or non-sterile compounding, with at least 2 years in R&D leadership roles.
- Deep knowledge of USP <795>, <797>, <800>, cGMP, and FDA guidance.
- Demonstrated expertise in formulation development, stability testing, and analytical methods.
- Strong project management, leadership, and communication skills.
Ability to manage multiple projects, prioritize deadlines, and work cross-functionally
Key Competencies
Innovation and scientific curiosity
- Strong analytical and problem-solving ability
- Meticulous attention to detail and documentation
- Leadership and team development
Regulatory and compliance expertise
Why Join Southend Pharmacy?
Play a pivotal role in supporting pharmacy operations that directly impact patient health and safety.
- Be part of a collaborative, mission-driven team focused on innovation and excellence.
- Competitive salary and comprehensive benefits package.
Opportunities for professional development and career advancement.