Our client, a specialized and stable pharmaceutical facility in the mid west, is looking for a Director of Scientific Affairs to lead the scientific and technical aspects of API development and manufacturing within the company. This role involves strategic planning, project management, regulatory compliance, and collaboration with internal teams and external stakeholders to ensure that API products meet the highest standards of quality, safety, and efficacy. The Director of Scientific Affairs will serve as the scientific leader, guiding innovation and ensuring alignment with the company's goals and industry regulations.

Responsibilities:

Leadership & Strategy:

• Lead the Scientific Affairs department, providing strategic direction and vision for API development and manufacturing.
• Collaborate with senior management to develop and implement scientific strategies that align with company goals.
• Stay abreast of industry trends, scientific advancements, and regulatory changes, and integrate these into the company’s strategies.

Scientific Oversight:

• Oversee the design, development, and optimization of APIs, ensuring scientific rigor and innovation.
• Ensure the technical feasibility and scientific validity of new projects and initiatives.

Regulatory Compliance:

• Ensure compliance with global regulatory requirements, including Good Manufacturing Practices (GMP), and oversee the preparation of regulatory submissions (e.g., DMF, IND, NDA).
• Liaise with regulatory agencies and represent the company in scientific and regulatory discussions.

Qualifications:

• Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field. Advanced degrees (PharmD, MD) may also be considered.
• A minimum of 10 years of experience in the pharmaceutical industry, with at least 5 years in a leadership role within API development or manufacturing.
• Deep understanding of the API manufacturing process, including scale-up, process development, and regulatory requirements.
• Strong knowledge of GMP, FDA, EMA, and ICH guidelines and regulations.
• Proven track record of successful project management and delivery of API products.