Cambrex High Point Director, R&D and Project Management in Charles City, Iowa
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, 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.
Responsible for the Chemical Research and Development (CRD), Analytical Research and Development (ARD) and Project Management (PM) teams at Cambrex Charles City (CCC), including direct supervision of department heads for each of these groups. High level responsibility for seamless integration of personnel and resources allocated to client programs stemming from late stage clinical development through commercialization. Works closely to ensure timely completion of critical chemical development activities in support of CCC Operations. Works closely with leaders at other Cambrex sites in order to maximize the utilization of cross-site FTE support to further accelerate project timelines. This position aligns closely with Cambrex Business Development in support of winning new business locally for CCC and globally for Cambrex partner sites. Responsible for development and review of client proposals for new and existing programs, and shared oversight for monthly invoicing. Serves as liaison for coordination of programs between Cambrex sites, and provides team leadership for cross-site initiatives. Member of the CCC executive leadership team, and serves as backup for CCC site-head, when needed.
Essential Functions /Principal Accountabilities:
Direct responsibility for CCC Chemical Development, Analytical Development and Project Management departments; provides leadership and management of R&D activities in support of the CCC Operations team.
Works closely with CCC Site Head and CCC Leadership Team to coordinate site resource allocation, finances, quality, training, performance management, and personnel development.
Works with CCC Senior Management and Cambrex Global Leadership to provide long-range business planning and guidance, including strategic initiatives.
Aligns closely with business development and Cambrex clients for development of new proposals, and provides direct support for downstream resource coordination, including business review meetings, technical reviews, troubleshooting, negotiation, and reconciliation.
Principle subject matter expert in chemical development, pharmaceutical science, process development, analytical chemistry, technology, and cGMP regulations, including application of this knowledge to ongoing work activities.
Shared responsibility for ensuring safe work practices in all areas of CCC.
Works to ensure that a spirit of teamwork, inclusiveness, cooperation, and can-do attitude exists within departments of responsibility as well as the larger Cambrex Organization.
- Publications, Presentations, and Patents
Ph.D. or equivalent degree with at least 10+ years of hands-on experience in pharmaceutical chemical process development
Desirable Experience and Skills:
Excellent leadership skills.
Strong project management skills.
Strong skills and knowledge in organic chemistry, especially as applicable to process chemistry.
Strong understanding of analytical project requirements.
Strong understanding of FDA guidance and process for submission of regulatory documents in support of client filings.
Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected.
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. (https://careers-cambrex.icims.com/jobs/1999/director%2c-r%26d-and-project-management/job?mode=apply&apply=yes&in_iframe=1&hashed=-336240429)
Job LocationUS-IA-Charles City
Type Regular Full-Time