Executive Director, Drug Product Development (Shanghai, China)
Lead the formulation development and Clinical Trials (CT) product manufacturing groups within the PDS department; function in both, a business as well as a technical role; must have solid oral dose formulations experience.
Contribute to growth of formulations business by using existing contacts and establishing contacts with new customers.
Have independent responsibility for revenue targets for contribution to department revenues.
Build new capabilities within the formulation / CT mfg group, by building up team and by evaluating new technologies/ equipment which can bring value to the customers
Play a lead role during audits by customers and regulatory agencies by co-ordinating with Department head and Drug product QA Director
Contribute to budgeting process of formulation / CT manufacturing part and ability to operate within budget by maximizing efficiencies and pioneering innovative techniques.
Work closely with department head to meet project timelines, departmental goal, and customer requests.
Co-ordinating with the customer for new projects, preparing technical proposals addressing their needs and drawing up cost estimates for project work. Co-ordinate with customer service on project proposals for customers.
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.
Participate in telecons, prepare update reports on ongoing projects to keep customers briefed on progress of projects , also prepare final reports for closing of projects
Co-ordinating for projects with different functions within WuXi to ensure smooth movement of projects as per set timelines.
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.
Demonstrated record of accomplishments in the formulation development of solid and liquid oral dosage forms intended for Phase I/II clinical trials.
Must be able to work in a team-oriented manner in order to accomplish performance objectives.
Must be proficient with the requirements of the FDA/ EMEA cGMP regulations, ICH guidelines as well as drug development process.
Experience in handling of formulation development for late stage dosage forms upto technical transfers is desired.
Problem solving ability and adept handling of formulation teams is also required.
li technical expertise in formulation development and CT manufacturing
li communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.