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Director, Drug Substance Manufacturing

Company: Cambrex Corporation
Location: Longmont
Posted on: February 25, 2021

Job Description:

At Cambrex, it's our people that set us apart. We work locally and have an impact globally. We're committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, STD, LTD, generous vacation in your first year, sick time, and retirement savings!Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal - to improve the quality of life for our customers' patients across the world. Overview The Director of Drug Substance Manufacturing is responsible for small molecule drug substance production in pilot plant manufacturing operations in support of client projects. This position has direct oversite of the drug substance manufacturing team which consists of skilled chemists and manufacturing personnel. The Director will support the achievement of site operational objectives as well as drive strategic growth opportunities in alignment with business unit and company goals. Responsibilities

  • Direct drug substance manufacturing of pre-clinical/clinical batches at the kilogram scale, in both non-GMP and GMP pharmaceutical suites.
  • Work in partnership with process chemistry, quality, analytical services, project management and to meet client objectives as well as commercial manufacturing areas to execute technology transfers.
  • Ensure cGMP data meets internal data evaluation procedures, client expectations and government regulatory requirements.
  • Oversight of synthetic process safety controls as well as work with Facilities/EH&S to ensure all safety policies are followed and issues addressed.
  • Develop and implement production control systems including master scheduling, production planning and coordination, and manufacturing performance reporting. Create reports and visual systems to reflect scheduling, performance, process procedures, and project evaluations.
  • Troubleshoot manufacturing issues, assess pilot plant capabilities and make recommendations for equipment maintenance and upgrades.
  • Lead a proactive culture of learning and employee career growth: Recruit, train, develop, mentor and retain operations staff.
  • Drive strategic growth for the functional unit and achieve financial objectives.
  • Build strong and effective relationships with customers and prospective clients; provide timely reports and feedback; support client visits, audits, and inquiries; and ensure overall client satisfaction.
  • Communicate effectively about complex technical issues with team members, clients, management and non-technical stakeholders.
  • Actively participate as a member of the site leadership team.
  • Maintain a high level of professional and technical expertise by staying abreast of and contributing to scientific literature, conferences, webinars and training opportunities. Qualifications
    • Requires a life sciences degree in Organic Chemistry or Chemical Engineering, or closely related field. Masters degree or Ph.D. preferred.
    • 10+ years of relevant experience in a GMP pharmaceutical chemical manufacturing environment.
    • Strong knowledge of functional area including physical chemistry, organic synthetic chemistry and reaction mechanisms.
    • Broad knowledge of the drug development process spanning pre-clinical through NDA registration.
    • Excellent communications skills - technical and business writing, listening and speaking.
    • Experienced in Quality by Design techniques for developing quality pharmaceutical substance manufacturing processes.
    • Experience working in or with CDMO / CRO laboratories.
    • Demonstrated leadership and interpersonal skills to effectively lead, mentor, influence, collaborate, and work with individuals, colleagues and clients.
    • Operational Excellence: Demonstrated ability to enhance operational efficiencies through systems management, continuous improvement, performance management, and project prioritization.
    • Organizational Leadership: Provide leadership, training and mentoring to staff and foster a strong sense of teamwork. Demonstrated ability to work in partnership with other departments and across several disciplines.
    • Business Acumen: To drive high performance in our complex manufacturing organization, must balance strong technical leadership with business acumen. Understand business and technical operations, and balance resources needed to meet strategic goals and plans. Be the first to receive our latest news updates

Keywords: Cambrex Corporation, Longmont , Director, Drug Substance Manufacturing, Executive , Longmont, Colorado

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