Position:Director formulation development (Shanghai)
Key accountabilities:
Lead the formulation development and Clinical Trials (CT) product manufacturing groups within the PDS department; function as both, a technical lead as well as a project co-ordinaotor role.
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.
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.
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
Co-ordinating for projects with different functions within WuXi
Expected to work closely with department head to meet project timelines, departmental goal, and customer requests.
Reviewing the pilot plant schedule to ensure optimum usage of plant to avoid clashes of scheduling of projects.
Play a technical role during audits by customers and regulatory agencies by co-ordinating 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
Scope of the job.
Be expected to perform the assigned job functions independently with limited supervision from upper management.
Must be able to work with multiple projects and prioritize the workload to meet the pre-determined timelines.
Individuals will be expected to accomplish their work assignments by interacting closely with fellow scientists and by developing cooperative working relationships with other personnel inside the company; communicate effectively with customers when needed and instructed.
Good communication, open exchange of information and project teamwork will be required in order to meet job performance. There must be strong recognition of high performance standards and of meeting assignment target dates at the individual job level as well as for the benefit of coworkers on project teams
Core business/Functional skills and education. What are the critical experiences, training skills, education, or capabilities?
MS or Ph.D. degree in Pharmaceutics or other directly-related science discipline with experience or training in formulation development.
Must be profecient with the requirements of the FDA/ EMEA cGMP regulations, ICH guidelines as well as drug development process.
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.
Experience in handling of formulation development for late stage dosage forms upto technical transfers is required.
Problem solving ability and adept handling of formulation teams is also required.
Strong technical expertise in formulation development and CT manufacturing
Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.
