Job Description

Department Details
Role Summary
RESPONSIBILITIES:
1. Define the vision, strategy, and roadmap for the Center of Excellence (CoE) in downstream recovery and process optimization.
2. Establish the CoE as a hub of innovation, technical expertise, and best practices in biologics manufacturing.
3. Evaluate, recommend, and champion advanced technologies and methodologies to improve process robustness, efficiency, and product quality.
4. Lead identification, planning, and execution of proof-of-concept (PoC) studies for novel technologies and ensure successful integration into manufacturing.
5. Build partnerships with technology providers, academic collaborators, and internal teams to drive innovation.
6. Continuously monitor and review downstream processes to identify gaps, resolve issues, and maintain a validated state of control.
7. Drive process improvement initiatives including:
a. Process optimization and debottlenecking
b. Scale-up and technology transfer of improved processes
c. Productivity enhancement and cost reduction
8. Collaborate effectively with manufacturing, quality, regulatory, supply chain, and R&D teams to align CoE initiatives with business objectives.
9. Lead or contribute to cross-functional forums for root cause analysis, problem-solving, and risk management of complex technical issues.
10. Author and review high-quality process, QMS, and regulatory documents ensuring technical accuracy and compliance.
11. Support regulatory submissions with robust scientific and technical justifications.
12. Collect, analyze, and interpret complex process data using advanced analytics and digital tools to guide decisions and demonstrate CoE value.
13. Build, mentor, and lead a team of experts, fostering a culture of excellence, innovation, and continuous learning.
14. Ensure effective knowledge transfer and capability development within the team and across the organization.
15. Ensure ongoing compliance with regulatory, quality, and data integrity requirements.
16. Proactively identify potential risks, develop mitigation plans, and ensure audit readiness for internal and external audits.
Key Responsibilities
RESPONSIBILITIES:
1. Define the vision, strategy, and roadmap for the Center of Excellence (CoE) in downstream recovery and process optimization.
2. Establish the CoE as a hub of innovation, technical expertise, and best practices in biologics manufacturing.
3. Evaluate, recommend, and champion advanced technologies and methodologies to improve process robustness, efficiency, and product quality.
4. Lead identification, planning, and execution of proof-of-concept (PoC) studies for novel technologies and ensure successful integration into manufacturing.
5. Build partnerships with technology providers, academic collaborators, and internal teams to drive innovation.
6. Continuously monitor and review downstream processes to identify gaps, resolve issues, and maintain a validated state of control.
7. Drive process improvement initiatives including:
a. Process optimization and debottlenecking
b. Scale-up and technology transfer of improved processes
c. Productivity enhancement and cost reduction
8. Collaborate effectively with manufacturing, quality, regulatory, supply chain, and R&D teams to align CoE initiatives with business objectives.
9. Lead or contribute to cross-functional forums for root cause analysis, problem-solving, and risk management of complex technical issues.
10. Author and review high-quality process, QMS, and regulatory documents ensuring technical accuracy and compliance.
11. Support regulatory submissions with robust scientific and technical justifications.
12. Collect, analyze, and interpret complex process data using advanced analytics and digital tools to guide decisions and demonstrate CoE value.
13. Build, mentor, and lead a team of experts, fostering a culture of excellence, innovation, and continuous learning.
14. Ensure effective knowledge transfer and capability development within the team and across the organization.
15. Ensure ongoing compliance with regulatory, quality, and data integrity requirements.
16. Proactively identify potential risks, develop mitigation plans, and ensure audit readiness for internal and external audits.
Educational Qualifications
Required Education Qualification: M.Sc
Required Experience: 8 - 12 years