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Post : Team Lead - Formulation Development
Job Description
Position Purpose
The role of the Team Lead is to provide scientific leadership, lead, plan, and coordinate all formulation and process development activities associated with the formulation of xxx, as well as to ensure that the requirements of projects, internal customers and external customers are met in terms of quality, cost and timeliness. These activities will be performed in alignment with the Department Head.
Major Accountabilities
Responsible for providing scientific leadership and project management for multiple projects. Plan, coordinate, implement and take full responsibility for all designated tasks associated with formulation development. Develop detailed plans and timelines with the manager, develop formulation strategies and plans for designated projects from development to cGMP manufacture. Ensure accurate, speedy reports are produced to enable regulatory filings. In cooperation with the manager, ensure designated projects are provided with sufficient resources to enable them to proceed to plan. Assist in the preparation of the annual budget for the group. Process characterisation, optimisation and validation of process systems utilizing appropriate statistically sound experimental design. Manage the identification, development and training of equipment and formulation technologies that support advancements in the development of new and improved pharmaceutical products and processes. Provide and check raw data documentation, evaluation and results interpretation. Provide input for the selection of next experiments / project steps. Address and solve problems. Optimize existing and develop more efficient and robust processes for the manufacture of drug products. Support as deputy during absences of other team leads and department head in case required Manage a team of scientists and technicians. Coach and develop them and create a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify and communicate competency gaps. Ensure tailored training and development plans are in place. Identify, verify and implement action to improve performance of the croup and actively support operational excellence work stream. Liaising with project leaders, Department Heads, Quality Managers and external collaborators Interact/collaborate with other departmental members/groups /functions to facilitate transfer of knowledge and deliveries of oncology generic and super-generic products. Perform and supervise the successful technological transfer of our processes to production sites according to global and local procedures. Generate scientific documents (e.g. development report) to hand over to internal and/or external partners and support generation of international registration documents under moderate supervision.
Candidate Profile
M.S. or PhD Degree in Pharmaceutical sciences or similar with a strong rele-vant industry experience Fluent in English (written and spoken) Extensive experience minimum 8 years in the pharmaceutical industry (MNC pre-ferred) In-depth understanding of generic drug product development and good understanding is a plus Track record in leading, motivating a small team In-depth knowledge of c-GMP standards Strong scientific skills allowing the drawing of accurate assump-tions from limited data to assess the next step in a development program on restricted timelines Understanding of analytical techniques and various formulation and process technologies Computer literate especially with suite of PC software packages at SDC. Good people management, communication and presentation skills. Have excellent resource planning and scheduling skills. Ability to excel in highly pressured environment Ability to liaise across teams to ensure common goals are achieved Affable, personable, diplomatic and open in communication.
Additional Information
Experience : 5+ years
Qualification : M.S. or PhD Degree
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 10th July, 2019
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