Manufacturing Science and Technology Leader

2 weeks ago


Richmond, Virginia, United States Medicines for All Institute Full time

Job Summary:

Medicines for All Institute is seeking a highly skilled Manufacturing Science and Technology (MSAT) leader to join our team. As a key member of our organization, you will be responsible for overseeing the implementation of robust and efficient manufacturing processes and the continuous advancement of our manufacturing assets and capabilities.

Key Responsibilities:

The successful candidate will have a strong technical background in small molecule drug substance manufacturing, a passion for building and leading high-functioning manufacturing teams, and excellent problem-solving skills. They will foster a culture of safe operations, stringent regulatory compliance, and continuous improvement.

Key Responsibilities:

  • Lead efforts to develop, optimize, and scale up manufacturing processes for drug substances and drug products
  • Design laboratory experiments to support process design, optimization, and technology transfer objectives
  • Ensure thorough characterization of intermediate and API processes and products
  • Define scientifically robust, defensible control strategies for API manufacturing and reduce them to practice via unit operation requirements
  • Manage the transfer of manufacturing processes from development to clinical and commercial production – internally, and to third-party manufacturing operations (CDMOs, CMOs, etc.)
  • Collaborate with process chemists and engineers to develop, and advance robust manufacturing processes – internally, and at third-party manufacturers
  • Identify and implement advanced technologies and innovative approaches to improve manufacturing processes and capabilities (e.g., PAT, in silico modeling)

Requirements:

  • Master's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Pharmaceutical Engineering or a related field. Ph.D. preferred
  • Minimum of 10 years of experience in pharmaceutical manufacturing (drug substance / active pharmaceutical ingredients), with a focus on manufacturing science and technology (MSAT)
  • Experience in the successful design, development, and commissioning of regulator-approved drug substance manufacturing facilities (experience with Early Phase clinical manufacturing facilities is a plus)
  • Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EMA)
  • Proven experience in leading innovation and managing teams, with a demonstrated ability to develop talent and foster a culture of teamwork and continuous improvement
  • Excellent problem-solving and troubleshooting skills
  • Strong leadership and project management abilities
  • Excellent communication and interpersonal skills
  • Ability to work effectively in a fast-paced, collaborative environment
  • Willingness to travel domestically and internationally (anticipated up to 10% of time)

Work Environment:

The primary worksite for this role will be the early clinical-scale manufacturing facility (pilot plant) in Chesterfield, Virginia, which is currently under development. During the construction phase of the scale-up facility, this role will be based out of our downtown Richmond site and will require occasional travel between the two sites.

Compensation:

Up to $160,000, commensurate with qualifications



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