About Stelis
Stelis Biopharma is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), with a complete and integrated end-to-end offering. We work side-by-side with our clients as true partners, with customer-centric collaboration and communication. We provide world-class process development and manufacturing infrastructure for both drug substance (mammalian and microbial-based therapeutic proteins and viral vectors) and drug product (lyophilized vials, liquid vials, pre-filled syringes, cartridges and devices). Our highly experienced quality and regulatory personnel help us meet global quality standards, ensure compliance and guide our clients through the regulatory approval process. Our three state of the art facilities are staffed by over 700 highly talented professionals. As the most agile CDMO in the industry, Stelis Biopharma is a trusted CDMO partner of choice. To learn more, visit www.stelis.com
Primary responsibilities
- Accountable for the overall functioning of upstream area of microbial or mammalian facilities
- Commission and qualify facility and equipment in coordination with the projects team
- Accountable for scale-up and tech transfer for clinical / commercial manufacturing
- End-to-end facility management for upstream, ensure GMP compliance and safety for upstream activities and people
- Prepare / review GMP documents such as SOPs, BMRs, protocols / reports for GMP compliance
- Responsible for QMS for change management and deviation management
- Maintain QMS during internal / external audits
- Accountable for protocols / reports for process validation / cleaning validation, campaign summary reports, etc.
- Prepare and track annual budgets as per the production plan
- Responsible for preparing production plan, execution, monitoring and compliance
- Recruit, onboard and develop team members
- Responsible for continuous improvement in USP manufacturing and periodically update self and the team on latest technologies
Key requirements
- Bachelor’s in biotechnology / chemical engineering or master’s in biotechnology with minimum 12 years of relevant experience
- Deep understanding of fermentation and bioprocess upstream equipment, abilities to perform fermentation, harvest, centrifugation, homogenization TFF for varied applications with integrated knowledge on all aspects of downstream processing
- Knowledge of cGMP and regulatory requirements of the biologics industry
- Demonstrated abilities to build and lead teams, collaborate with cross-functional teams and internal & external stakeholder management
Reference code: GLDSU01