Lead Technical Operations/ Technology Transfer (Formulations)

Walter Bushnell; Haridwar; Vor Ort; INR 900.000 - 1.300.000; Vollzeit

Zusammenfassung

Walter Bushnell seeks a professional to drive New Product Technology Development and support seamless transfer from development to commercial scale while ensuring quality, compliance, cost-efficiency, and supply continuity. The role covers technology transfer, process scale-up, cross-functional collaboration, analytical support, and leadership development to uphold cGMP and regulatory readiness.

You will coordinate with R&D, manufacturing, QA, regulatory, and purchase teams, supervise budgeting,

Aufgaben

• New Product Technology Development: New Product Introduction (NPI) support; Scale up from Development Lab to Pilot and Exhibit Stage; Equipment selection, budgeting and scale-up strategy development; Coordinate RM, PM & Tooling for technology transfer; Risk assessment and scale-up protocols/reports; Cross-functional coordination with R&D, Manufacturing, Quality, PMO, Purchase, Regulatory and Engineering teams for timely registration batches; Trouble shooting during scale-up and Exhibit batch execution; Technology development documentation and compliance; Support Regulatory Dept. in filing dossiers.

Jobbeschreibung

Role & responsibilities

Seamless transfer of Product, Process, Technology and knowledge from Development Lab. to Commercial Scale, while maintaining quality, compliance, cost-efficiency and supply continuity

1. New Product Technology Development :

• - New Product Introduction (NPI) support
• - Scale up of process from Development Lab. to Pilot and Exhibit Stage
• - Equipment selection, Budgeting and Scale-up strategy development
• - Coordinate RM, PM & Tooling for technology transfer
• - Risk assessment and mitigation planning, Scale-up protocols and reports
• - Cross-functional coordination with R&D, Manufacturing, Quality, PMO, Purchase, Regulatory and Engineering teams for timely execution of Registration batches
• - Trouble shooting during scale-up and Exhibit batch execution
• - Technology Development documentation and compliance
• - Support Regulatory Deptt. in filing of dossiers

2. New Product Launch and Commercial Manufacturing support :

• - Planning Process Evaluation and Process Validation batches along with Mfg. team
• - Support to mfg. for timely new product launches, Life-cycle management and site transfers
• - Process performance monitoring during initial commercial batches
• - Process optimization and productivity improvement initiatives
• - Management of post approval changes
• - Trouble shooting & timely intervention to avoid disruption in market supply
• - Support alternate vendor development for API & Excipients and participate in cost saving projects
• - Support investigations of OOT, OOS, Deviations, Market or Customer complaints & CAPA
• - Ensure compliance with cGMP, Quality Policy, EHS and SOPs. Identify and assess potential Occupational and Process safety hazard and take appropriate action

3. Analytical and Quality support

• - Analytical Method Transfer co-ordination
• - Ensure timely communication to ensure QC Laboratory readiness and qualification
• - Stability Program support
• - OOS/ OOT Investigation support
• - Analytical method trouble shooting and optimization

4. Leadership & Development

• - As a go-to resource for R&D/ Manufacturing for Process Knowledge and Scale-up strategy and keep upgrading the skill set continuously
• - Budgeting for Technology Transfer activities
• - Hiring, training, development and retention of team
• - Developing best systems and practices for the function