Director, Formulation Development
SUMMARY / OBJECTIVE
Provide strategic and scientific leadership for Sovereign's Formulation Development organization to ensure the successful design, development, regulatory filing, technology transfer, scale-up, and commercial launch of 505(b)(2), ANDA, ANADA, OTC, and other complex pharmaceutical products. Lead formulation and process development initiatives, establish departmental strategy, drive innovation, manage a portfolio of development programs, and collaborate with executive leadership to support corporate growth objectives. Ensure compliance with all applicable regulatory requirements while fostering a high-performance, scientifically driven culture.
ESSENTIAL FUNCTIONS
Leadership & Strategy
- Direct and oversee all Formulation Development activities across multiple development programs and dosage forms.
- Develop and implement departmental goals, strategies, and key performance indicators aligned with business objectives.
- Serve as the scientific and technical leader for formulation development, providing guidance on complex development challenges and critical decision-making.
- Build and maintain a high-performing team through talent acquisition, coaching, mentoring, succession planning, and leadership development.
- Establish resource allocation strategies and prioritize departmental workload to ensure efficient execution of projects.
- Develop and manage departmental budgets, capital expenditures, equipment investments, and external vendor relationships.
- Evaluate emerging technologies, industry trends, and scientific advancements to drive innovation and competitive advantage.
Product Development & Technical Operations
- Provide oversight of formulation development activities from pre-formulation through commercialization.
- Lead development strategies for solid, semi-solid, liquid, and other pharmaceutical dosage forms.
- Oversee formulation design, analytical characterization, manufacturing process development, scale-up, and process optimization activities.
- Review and approve development protocols, technical reports, manufacturing instructions, technology transfer packages, and regulatory documentation.
- Guide troubleshooting efforts for complex technical, formulation, manufacturing, and stability-related challenges.
- Ensure robust product development strategies that support successful regulatory submissions and commercial launches.
- Oversee raw material evaluations, excipient selection, compatibility assessments, and formulation optimization efforts.
- Provide strategic leadership for technology transfer activities both internally and with external manufacturing partners.
Portfolio & Project Management
- Lead a portfolio of development projects, ensuring milestones, timelines, budgets, and deliverables are achieved.
- Partner with Project Management, Regulatory Affairs, Quality Assurance, Analytical Development, Manufacturing, and Commercial teams to drive product development success.
- Assess development risks and implement mitigation strategies to ensure project continuity and regulatory success.
- Present portfolio updates, business cases, project recommendations, and development strategies to executive leadership.
- Support due diligence evaluations for potential licensing opportunities, acquisitions, partnerships, and business development initiatives.
Regulatory & Compliance Leadership
- Ensure compliance with applicable FDA, DEA, EPA, OSHA, ICH, USP, and cGMP regulations.
- Provide strategic support for regulatory filings, agency responses, inspections, audits, and compliance initiatives.
- Represent Formulation Development during regulatory inspections, client audits, and customer visits.
- Ensure adherence to data integrity requirements, quality systems, laboratory standards, and corporate policies.
- Drive continuous improvement initiatives to enhance compliance, efficiency, and scientific excellence.
Scientific Leadership
- Serve as the subject matter expert in formulation development and pharmaceutical sciences.
- Provide technical guidance on Quality by Design (QbD), risk assessment methodologies, Design of Experiments (DOE), process development, and scale-up strategies.
- Foster a culture of innovation, scientific rigor, and continuous learning.
- Lead initiatives focused on improving formulation performance, manufacturability, product quality, and operational efficiency.
- Encourage publication, presentation, and knowledge-sharing activities that enhance the organization's scientific reputation.
Client & External Relationships
- Serve as the primary scientific representative for clients, partners, consultants, and external stakeholders.
- Develop and maintain strong relationships with customers, contract service providers, suppliers, and regulatory agencies.
- Lead technical meetings, client presentations, teleconferences, and site visits.
- Support business development activities by providing technical expertise during customer engagements and proposal development.
Additional Responsibilities
- Recruit, develop, and retain top scientific talent.
- Conduct performance evaluations and establish professional development plans for management-level direct reports.
- Champion cross-functional collaboration and organizational effectiveness initiatives.
- Perform other duties as assigned.
