Formulation Development Director or above
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.
- Contribute to growth of formulations business by using existing contacts and establishing contacts with new customers.
- Have independent business development responsibility for revenue targets for contribution to department revenues.
- Build new capabilities (like modified release) 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.
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 teams and prioritize the workload to meet the pre-determined timelines.
- Individuals will be expected to accomplish their work assignments by interacting closely with project team leaders and by developing cooperative working relationships with other personnel inside the company and communicate effectively with customers.
- 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
- MS or 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 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.
Any applications, pls contact: firstname.lastname@example.org; email@example.com