Formulation Development Director or Sr. Director (Shanghai, China)
Provide technical oversight (guidance) to formulation development staff and clinical trial
product manufacturing staff in both development and manufacturing projects.
Plan, co-ordinate, and oversee the work activities of scientific staff within the different groups. Provide technical guidance to group leaders and troubleshoot personally on the shop floor where necessary to ensure smooth progress of projects.
Coordinating with the customer for new projects, preparing technical proposals addressing their needs and drawing up cost estimates for project work. Coordinate with customer service on project proposals for customers.
Participate in telecons, review update reports on ongoing projects to keep customers briefed on progress of projects , also prepare final reports for closing of projects.
Coordinating for projects with different functions within WuXi.
Expected to work closely with department head to meet project timelines, departmental goal, and customer requests.
Play a technical role during audits by customers and regulatory agencies by coordinating with WuXi QA Director.
Plan for technological upgrades of the capabilities of the formulation group/ CT , by evaluating new technologies/ instruments which can bring value to the customers.
Contribute to growth of formulations business by using existing contacts and establishing new contacts with customers.
Contribute to budgeting process of formulation / CT manufacturing part and ability to operate within budget by maximizing efficiencies and pioneering innovative techniques.
Have independent responsibility for revenue targets for contribution to department revenues.
Ensuring ongoing training programs within department to ensure continuous growth of department personnel.
Ph.D. degree in Pharmaceutics or other directly-related science discipline with sufficient experience or training in formulation development as well as clinical product manufacturing..
Experience in handling of formulation development for late stage dosage forms up to technical transfers is desired.
Demonstrated record of accomplishments in the formulation development of solid and liquid oral dosage forms intended for Phase I/II clinical trials.
li communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.
Must be able to work in a team-oriented manner in order to accomplish performance objectives.
Problem solving ability and adept handling of formulation teams is also required.
Must be proficient with the requirements of the FAD/EMEA cGMP regulations, ICH guidelines as well as drug development process