Director of Development - Cook Pharmica

Description Position Summary: The Director of Scientific Affairs (Development) is responsible for technically understanding and leading the development and improvement of cell culture and purification processes and operations and analytical methods, adhering to customer, regulatory, safety and environmental requirements and guidelines. The Director is expected to develop a thorough understanding of the process and apply his/her technical knowledge to lead the development or adaptation of a process, such that it is suitable for manufacturing. Additionally, he/she will facilitate the establishment of a process control strategy and will ensure that the development group assists in the identification and resolution of manufacturing problems using sound scientific and statistical methods, while working with a diverse group of people from manufacturing and various support groups. The Director is also expected to apply his/her knowledge to suggest process improvements that may be of value to the customer. The Director is responsible for ensuring that the development group designs, conducts and evaluates laboratory experiments, and supports plant trials using statistical thinking. He/she also supervises, reviews and approves appropriate manufacturing protocols, procedures, reports and other documentation as necessary to support the customer and manufacturing operations.
The Director of Scientific Affairs (Development) is responsible for serving as a member of the organization’s leadership team. He/she must interact with customers and potential customers on business and technical issues and must represent the organization from a technical perspective. The Director is responsible for building and maintaining an appropriate technical team, ensuring its contributions to the organization and establishing the principles that guide its day-to-day operations, with particular emphasis on meeting organizational diversity, safety, quality, environmental, teamwork and respect for people goals.

Primary Responsibilities: (will include other duties as needed)

Lead the design, evaluation, and development of systems to produce recombinant proteins. This includes the cell culture, purification and analytical characterization of these proteins.

Lead the development of new "tools" by recommending and encouraging the investigation and evaluation of new technologies for process improvement or future use.

Coach scientists and technicians in the technical aspects of their jobs and in developing their careers.

Administer staff according to the principles, goals and requirements of the organization.

Serve as the technical advisor and consultant for the leadership team and customers.

Other duties as assigned.

Essential Skills and Experience:

Ph.D. in Chemistry, Chemical Engineering, Molecular Biology, Biochemistry, or related area or equivalent.

The candidate needs 15 or more years postdoctoral experience studying or working with a wide variety of systems (bacteria, yeast, insect, mammalian cells) suitable for expressing recombinant protein products and is experienced with the current theory and practice of protein purification, analytical characterization and cell culture development.

The candidate needs 15 or more years of experience and a proven track record in leading technical groups and administering technical staff.

The candidate should:
o have strong analytical skills and experience with bioprocessing and its related functions and activities, e.g., analytical characterization, cGMP manufacturing, cell culture, purification, scale-up, technical transfer, quality systems and regulatory interactions;
o have the appropriate laboratory (chromatography/HPLC) experience/training as well as a strong mechanical aptitude;
o be technically inquisitive, attentive to detail and must exhibit strong problem solving skills;
o exhibit leadership abilities and strong interpersonal skills;
o be able to work independently and be able to prioritize activities; and
o be observant and have strong communication skills (both verbal and written).

This dynamic individual must also be independent, multi-tasking and results-oriented with a hands-on attitude in a fast-paced and energetic start-up environment.

We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

Requirements Edu-4 year degree