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Responsibilities:-

• Head of KTC must make sure the following activities in his area of responsibilities:
  • Execution of Technical Projects.
  • Introduction of new products / formulation
  • Implementation of CI Projects.
  • Improvement in current manufacturing process like replacement of existing coating with better polymers as CIP and improve cGMP.
  • R&D Lab team activity monitoring.
  • Monitoring of GXP in R&D Lab area.
• Responsible for all the activities taking place in R&D Lab.
• Responsible for technical problem resolution in R&D Lab.
• Review of daily planning of R&D Lab (based on FIFO and priorities) considering attendance of the day. Also review the pending of the monthly projects.
• Responsible for writing, implementation and updating Standard Operating Procedures (SOP) for all manufacturing equipment/system used in R&D Lab.
• Periodic performance review of goals for current year against agreed upon goal and yearly review for all R&D group members for purpose of annual raises. Also discuss and set goals and growth plans for R&D staff for next year as per department/company strategies in annual PEx process.
• Plan, implement and monitor training certification schedule for all R&D Lab members.
• To provide help to subordinates in planning / organizing / leading and controlling activities, in their respective and assigned projects and to discuss with Director Operations, action taken and help provided in case of anticipated crossing of lead time so as to bring it with in the agreed upon lead time.
• To assist Director Operations, Head Count Calculation, identification of Capital items and budget preparation for R&D Lab.
• Responsible for R&D Lab Highlights preparation on weekly and monthly basis (As required).
• Technical support to affiliate for Continuous Improvement Projects when required.
• Help R&D Lab, analytical section for validation/verification of analytical methods via manufacturing of product’s placebo and product trials.
• Technical support to Abbott TPMs for the technicality transfer, FLQR package, Batch Size Enhancement and other technical matters.
• Help affiliate to develop new vendor as per affiliate vendor approval procedure.
• Help QC team for on-site audit request, risk assessment and other tasks related to new vendor approval (as required).
• To provide support to Analytical group for technical project.
• Responsible for new product development, Bill of Material, Manufacturing Directions, standard Test Methods, Master manufacturing formula, Packaging Approval Note and trial lot manufacturing. Preparation and sending of Drug Code Request (DCR), First Lot Quality Review Package.
• To check the Technical Packages prepared in R&D Lab, regarding Formula Change, Process Change and Method Development and Validation.
• Responsible for Raw Material and direct contact commodities vendor evaluation for new product.
• Responsible for determination of qualitative/ quantitative formula for all the ingredients used in new formulations.
• Evaluation for selection of suitable solvent system to be used in coating solution.
• Assistance to affiliate for evaluation of bioavailability (Bioequivalence) of new products (if required).
• Evaluation of color matching of the tablets as per commercial need, when developing new formula/changing in the formula (CIP).
• Selecting suitable method for conventional method to automated techniques according to the characteristics of actives/excipients used in new formulation/process improvement, e.g.: tray dryer to FBD, batch size increase etc.
• Any other activity as directed by Director Operations.

Knowledge & Experience:

• Knowledge of Documentation, Validation, Stability, Technical Problem Resolution and other activities taking place in R&D Lab.
• More than 15 years of experience in relevant filed.

Competencies required:

• Good computer skills
• Good Communication and interpersonal skills
• Negotiation Skills
• Leadership Skills
• Product Development and Analytical Skills
• Building organization and inspire people
• Technical skill to resolve formulation issues

Minimum Qualifications:

• B Pharm / Pharm D / M-Phil
• Preferably PhD in related field