Group Leader - PTD - Pharma

Position Title - Group Leader

Job Location - Paonta Sahib

Reports to - Director PTD

Supervises - PTD scientists/ executives/officers

Qualifications - MPharm / PhD in Pharmaceuticals or Chemical Engineering

Experience - 10+ years of experience

Accountabilities:

- The position will be responsible for overseeing the planning and successful and timely execution of scale up and exhibit batches at the plant.

- The role holder will also be responsible for guiding a group of scientists to ensure creation of appropriate technology transfer documentation and securing sign off from PTT.

Shared Accountabilities :

- Logistics planning for timely execution of EB for respective location, (shared with Mfg.), ensure availability of raw materials (shared with GSC).

- Making recipe and recipe revisions in SAP (shared with PTT).

- Ensuring uniform code creation and specs across different sites (shared with PDR).

- Support and collaborate with AD for analytical method validation/ transfer for analytical transfer documentation availability (shared with AD).

- Support to regulatory audits and addressing audit deficiencies by providing necessary documentation (shared with RA, QA).

- Drive continuous improvement to strengthen tech transfer processes, manage and report shared metrics for TT success (shared with PTT).

- Act as repository of technical expertise and support PTT team in investigation and resolution of technical issues during pre-validation, validation stage.

Job Profile and Expected Key Outcomes:

- Responsible for ensuring timely and successful execution of scale-up and EB, conduct of hold time studies as well as driving timely resolution of any technical issues.

- Planning for scale-up and EB slotting including EB calendar for respective location.

- Responsible for timely completion of all scale-up and EB documentation such as QMS task assigned in Track-wise and DCM.

- Share all scale-up/ EB scheduling plans and changes with PM team, GSC and Mfg.

- Ensure compliance to cGMP, regulatory requirements and SAP and continuous up gradation of systems.

- Ownership for creating relevant technology transfer documents and securing signoff from PTT/ Mfg.

- Test batch monitoring report, intended manufacturing instructions, PTD documents, process design summary report etc.

- Champion a Quality mindset- enable process robustness and implement Quality by Design.

- Budgeting and procurement of PTD requirements at location.

- Responsible for communicating change of composition to AD.

- Share back scale-up/ EB learning with PDR.

- Undertake source variation of API.

Nidhi Dhyani
+91.11.43138644