Senior Director, Pharmaceutics and Formulation

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Job description

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At Cambrex, its our people that set us apart. We work locally and have an impact globally. Were 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 Senior Director, Pharmaceutics and Formulation, is responsible for leading small molecule drug pharmaceutics and formulation development efforts to support early-stage CDMO projects. The position requires a balance of strong technical skills, leadership of scientific staff, collaboration with internal departments, and close partnerships with external clients. The Senior Director supports the achievement of site operational objectives, drives strategic growth opportunities in alignment with business unit and company goals, and serves on the site leadership team. This position reports to the Vice President Site Director, Cambrex Longmont.

Responsibilities:
Manage and oversee all aspects of pre-formulation characterization and formulation development, with an emphasis in solid oral and liquid dosage technologies (targeting pre-clinical through Phase II stage clinical development and manufacturing). This position works closely with Cambrex colleagues in other areas to support scientific efforts and ensure the successful completion of projects (Material Characterization, Process Chemistry and Analytical Services).Provide leadership to a team of scientists. Assure a high quality of scientific integrity, and innovation. Recruit, train, develop, mentor and retain staff, and lead a proactive culture of learning and employee career growth.Demonstrate and share capabilities with new and existing clients. Work with Cambrex Marketing and Business Development areas to develop and service contracts, and partner with Cambrex or external organizations to transition early-stage projects to commercial manufacturing. Role includes in-person and remote client meetings and webinars.Serve as a client-facing technical leader and work in partnership with clients/drug development organizations to meet their early-stage small molecule outsourcing needs. Nurture trusted relationships with clients who rely on Cambrex to develop innovative formulations, deliver data, solve complex technical issues, communicate achievable timelines, and ultimately achieve greater efficiencies in quality, time and cost. Communicate effectively about complex technical issues with team members, clients, management, and non-technical stakeholders.In alignment with Facilities/EH, ensure all safety policies are followed and issues addressed.Drive strategic growth for the functional unit and achieve financial objectives.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 Pharmaceutical Sciences, Chemistry or closely related field. Ph.D preferred.15+ years of relevant experience in a CDMO or pharmaceutical research environment, especially in the areas of early phase oral solid dosage formulation development.Strong knowledge of functional areas including pre-formulation, solubility, excipient compatibility, and solid form selection (salts, polymorphs, etc.).Provide guidance on various solubility enhancing technologies for PK/tox animal studies and early stage clinical trials.Broad knowledge of the drug development process, spanning pre-clinical through NDA registration.Excellent communications skills technical and business writing, presentations, listening and speaking.Demonstrated ability to work with clients on technical issues including discussing various options suited to their specific needs.Demonstrated leadership and interpersonal skills to effectively lead, mentor, influence, collaborate, and work with individuals, colleagues, and clients.SUCCESS FACTORS: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. Foster sense of teamwork and help transfer successful projects to commercial sites.Business Acumen: To drive high performance in our complex organization, must balance strong technical leadership with business acumen. Understand business and technical operations, monitor departmental revenue, and balance resources needed to meet strategic goals and plans.Operational Excellence: Demonstrated ability to enhance operational efficiencies through systems management, continuous improvement, performance management, operational excellence, and project prioritization. Proven excellence in managing multiple projects, focusing on quality and detail accuracy, and writing reports.