Medix™
Overview
Job Title: R&D Manager
Position Summary: The R&D Manager is responsible for planning, leading, and overseeing the activities of the Research & Development team. This includes developing new over-the-counter (OTC) drug or cosmetic products, improving existing formulations and packaging, and transitioning products from concept through to full-scale production. The role reports to the Director of R&D and ensures all projects align with the company’s strategic product development goals. This position requires strong technical knowledge, leadership, and project management capabilities. The R&D Manager serves as a key resource in formulating strategy, solving complex technical challenges, and mentoring junior staff. The role ensures compliance with regulatory standards, cGMP, Good Laboratory Practices (GLP), and company policies.
Key Responsibilities
- Lead formulation and testing of new or improved OTC drug or cosmetic products and packaging.
- Manage product scale-up from pilot to full production, including development of specifications and procedures.
- Research and implement emerging technologies, raw materials, and intellectual property relevant to the company’s products.
- Stay up-to-date on industry trends, scientific advancements, and regulatory changes.
- Evaluate formulation and line extension opportunities for potential product acquisitions.
Project Management & Communication
- Develop project timelines, budgets, and resource plans; provide regular status updates to leadership.
- Design and oversee clinical studies and claims substantiation initiatives.
- Prepare and deliver technical presentations, updates, and reports for internal and external stakeholders.
- Maintain high-quality documentation including protocols, regulatory submissions, and standard operating procedures.
- Manage and mentor R&D staff; conduct hiring, onboarding, performance evaluations, and career development planning.
- Foster a collaborative, high-performance team environment focused on innovation and continuous improvement.
- Ensure compliance with laboratory safety, confidentiality, and GLP standards.
- Support staff development through training, coaching, and regular feedback.
Operational Excellence
- Oversee daily R&D laboratory operations, ensuring regulatory compliance and operational efficiency.
- Identify and implement process improvements to enhance productivity and cost-effectiveness.
- Collaborate with cross-functional teams including marketing, manufacturing, clinical, and regulatory to support project success.
- Ensure that confidential and proprietary information is handled in accordance with company policies.
Qualifications
Education & Experience
- Bachelor’s degree in Chemistry or a related scientific discipline required; advanced degree preferred.
- Minimum of 10 years’ experience in R&D within the pharmaceutical, personal care, or healthcare industry.
- Demonstrated expertise in formulation development, product scale-up, and regulatory compliance for OTC or cosmetic products.
- In-depth knowledge of OTC monograph systems, cGMP, GLP, and relevant regulatory frameworks.
- Strong understanding of chemical properties, manufacturing processes, and OSHA regulations.
- Proficiency with data analysis tools, business software, and electronic documentation systems.
- Excellent analytical, organizational, and project management skills.
- Strong leadership and interpersonal communication skills.
- Ability to handle confidential information with discretion and professionalism.
- Capable of managing cross-functional teams and aligning diverse departments toward shared goals.
Managerial Responsibilities
- Oversee employee performance; provide guidance, coaching, and mentorship to R&D staff.
- Foster a positive, team-oriented work environment aligned with company values and objectives.
- Encourage staff participation in decision-making and process improvement initiatives.
- Define and execute staff development plans to support career growth and departmental excellence.
Additional Information
- This position operates with full authority as delegated by the Director of R&D and in accordance with company policy.
- Additional responsibilities may be assigned to support organizational needs.
- Expected to uphold company values, support continuous improvement, and contribute to quality initiatives.