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Scientific Affairs Director

2 months ago

Madison, Wisconsin, United States Germer International - Pharmaceutical Recruiting Full time

Job Summary:

We are seeking a highly experienced and skilled Director of Research and Development to lead our scientific and technical efforts in API development and manufacturing. As a key member of our team, you will be responsible for driving innovation, ensuring regulatory compliance, and collaborating with internal and external stakeholders to deliver high-quality API products.

Key Responsibilities:

  • Leadership and Strategy:
    • Develop and implement scientific strategies that align with our company goals and industry regulations.
    • Collaborate with senior management to drive business growth and innovation.
    • Stay up-to-date with industry trends, scientific advancements, and regulatory changes to inform our strategies.
  • Scientific Oversight:
    • Oversee the design, development, and optimization of APIs to ensure 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.
    • Liaise with regulatory agencies and represent our 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.