Continuous Manufacturing Expert
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
Position Overview: We are seeking an accomplished and highly skilled Continuous Manufacturing Expert with a strong background in small molecule drug production and experience in building and managing continuous manufacturing facilities. You will play a pivotal role in shaping our pharmaceutical manufacturing processes and driving innovation in the field of small molecule drug production.
Responsibilities:
● Continuous Manufacturing Strategy: Develop and lead the continuous manufacturing strategy for small molecule drugs, ensuring alignment with the organization's goals and regulatory requirements.
● Facility Design and Implementation: Utilize your expertise to oversee the design, construction, and commissioning of a state-of-the-art continuous manufacturing facility. This includes equipment selection, process development, and validation.
● Process Optimization: Collaborate with cross-functional teams to optimize continuous manufacturing processes for small molecule drugs, focusing on efficiency, quality, and cost-effectiveness.
● Regulatory Compliance: Ensure that all manufacturing processes, equipment, and facilities comply with regulatory standards and guidelines, including FDA and international regulations.
● Technology Assessment: Stay abreast of emerging technologies and best practices in continuous manufacturing, evaluating their potential application in small molecule drug production.
● Technical Leadership: Provide technical leadership and mentorship to a multidisciplinary team of scientists and engineers, fostering innovation and continuous improvement.
● Problem Solving: Troubleshoot manufacturing issues, identify root causes, and implement corrective actions to ensure uninterrupted production and product quality.
● Documentation: Maintain comprehensive documentation of processes, protocols, and validation records, adhering to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
● Collaboration: Collaborate with research and development teams to transition new drug candidates from development to commercial manufacturing, ensuring scalability and process robustness.
● Training and Development: Lead training initiatives to enhance the skills and knowledge of manufacturing personnel in continuous manufacturing techniques and best practices.
Requirements:
● Education: A Ph.D. or Master's degree in Chemical Engineering, Pharmaceutical
Sciences, or a related field is preferred.
● Experience: A minimum of 10 years of experience in continuous manufacturing of small molecule drugs, with a proven track record of managing and optimizing continuous manufacturing facilities.
● Facility Development: Demonstrated experience in designing, building, and commissioning continuous manufacturing facilities for pharmaceutical products.
● Regulatory Knowledge: Thorough knowledge of FDA and international regulatory requirements pertaining to continuous manufacturing of pharmaceuticals.
● Technical Expertise: Expertise in process development, equipment selection, validation, and quality assurance within a continuous manufacturing context.
● Leadership: Strong leadership and mentoring skills, with the ability to lead cross-functional teams and drive innovation.
● Problem-Solving Skills: Exceptional problem-solving skills and the ability to analyze complex manufacturing issues and implement effective solutions.
● Communication: Excellent communication skills, with the ability to convey complex technical concepts to both technical and non-technical stakeholders.
● Documentation: Proficiency in maintaining comprehensive and compliant documentation.
Location: This position is fully-onsite in Minden, NV.
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