About the Role
The role involves leading manufacturing science and technology activities for upstream bioprocesses, driving process understanding, supporting regulatory filings, and providing technical leadership during investigations and process improvements.
Responsibilities
- Lead technical investigations for deviations, out-of-specification results, and process anomalies in upstream biomanufacturing
- Support process performance evaluations and continuous improvement initiatives
- Conduct root cause analyses and implement corrective and preventive actions
- Collaborate with manufacturing and process development teams to resolve technical challenges
- Provide scientific expertise during technology transfer activities
- Develop and review technical reports and regulatory documentation
- Monitor and analyze process data to ensure product quality and process consistency
- Support process validation and process characterization studies
- Lead or contribute to process optimization projects
- Ensure compliance with cGMP regulations and internal quality standards
- Participate in risk assessments and process risk management activities
- Interface with external partners and contract manufacturing organizations
- Train personnel on technical processes and investigation methodologies
- Maintain up-to-date knowledge of industry trends and regulatory expectations
- Support inspection readiness and regulatory audits
- Drive adoption of data analytics tools for process monitoring
- Contribute to the development of process control strategies
- Assist in the scale-up and tech transfer of upstream processes
- Evaluate new technologies and equipment for process enhancement
- Ensure documentation accuracy and adherence to quality systems
Compensation
Competitive salary and benefits package
Work Arrangement
On-site with limited flexibility for remote work
Team
Part of the Upstream Process Development and Manufacturing team within Technical Operations
Why Join Us
- Opportunity to work on innovative biologic therapies with global impact
- Collaborative environment focused on scientific excellence and patient outcomes
- Career development and mentorship within a growing technical team
Our Commitment to Diversity
We value diverse perspectives and foster an inclusive workplace for all employees
