Director, Drug Substance Manufacturing
Company: Cambrex Corporation
Posted on: February 25, 2021
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
- 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
- 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
- Troubleshoot manufacturing issues, assess pilot plant
capabilities and make recommendations for equipment maintenance and
- Lead a proactive culture of learning and employee career
growth: Recruit, train, develop, mentor and retain operations
- Drive strategic growth for the functional unit and achieve
- 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
- Communicate effectively about complex technical issues with
team members, clients, management and non-technical
- Actively participate as a member of the site leadership
- 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
- 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
- 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
- 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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