Scientist, Upstream Process Development

DELIVERY FOCUS: On time delivery of upstream process development experiments as independent contributor and by coordinating team efforts

To coordinate team activities on day-to-day basis as senior member of the team

• Participation in execution of experiments for 25% of self work hours

• Supporting Leads in designing experiments by providing data in appropriate format.

• Explaining the approved DOE/OFAT experiment designs to the RAs.

• Resource management for experiments for flawless execution by ensuring availability of equipment, raw materials and consumables.

• Daily review of ongoing experimental data

• Collaborating with the purification for clarification of harvest materials and for NTEL generation. Coordinating with analytical and Bio-analytical teams for sample submission and analytical feedback.

• Oversees lab operations and equipment maintenance and participates in the smooth running of lab meetings and contributes to troubleshooting for potential causes for experimental failures and process performance aspects as relevant.

• Suggests corrective action in case of any deviation, and if required brings it to the notice of Leads.

• Deviation management: logging the deviation in to the Quality Management System, leading the investigation, proposing CAPA and timely closure of the investigation.

• Maintaining inventory of experiments and ensuring completion and drawing proper conclusion of each experiment.

DOCUMENTATION & REVIEW: Formatting raw data, Reviewing and Authenticating generated raw data, drafting descriptive documents

* Reviewing experimental data (LNBs/ ELN/ DRSs) as per the norms of the quality systems. Ensuring that the lab records are completed, and reviewed as per SOP.

* Ensuring accuracy and availability of the recorded raw data. Ensuring data integrity (correctness of data).

* Reviewing functional SOPs, SDPs and DRSs.

* Collabrating with PDQA for review, data authentication and archival of LNBs, DRSs, campaign plan/ protocols/ reports.

* Data collation and presentation in a comprehensive manner for further analysis.

* Generation of technical presentations elaborating each experimental outcome in order to communicate technical information within the function.

* Drafting descriptive scientific reports facing team deliverables (e.g., Process development summary, Tech Memo, Process Description Summary, BOM, campaign planning and protocols, etc.) maintaining global quality and as per regulatory standards with necessary and appropriate support from RAs and Leads.

LAB MANAGEMENT, SAFETY & QUALITY: Overseeing lab operations, equipment maintenance, safety and quality

* Ensuring compliance of the team with safety and quality standards and systems for smooth lab functioning.

* Coordinating with 'Lab-Ops' and 'Engineering' teams in case of equipment break-down to minimise the downtime.

* Ensuring the availability of RMs and consumables required for project.

* Escalating lab issues, if any, for technical/ engineering/ facility/ administrative support.

* Ensuring inventory updation by responsible personnel.

* Trouble-shooting problems related to equipment.

PEOPLE DEVELOPMENT: Creation of training modules, providing training to tech trainees and lateral hires

* Establishing function-specific training modules to support employee performance.

* Providing training to the Tech Trainees and lateral hires.

* Supporting junior team members to achieve their full potential.

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