- This role is responsible for providing technical oversight and direct support to manufacturing operations. In addition, supports troubleshooting equipment-related issues and develops process solutions to address identified problems. Acts as Manufacturing lead for tech transfer activities. Reports to a Manufacturing Manager.
About the role:
- Provides technical support for the manufacture of a gene therapy product. Supports troubleshooting equipment-related issues and develops process solutions to address identified problems.
- Writes/revises standard operating procedures (SOPs), training documents (OJTs) and batch records (BPRs).
- Acts as system owner to support equipment qualification / re-qualification
- Leads deviation investigations to adequately identify the root cause and implements appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence. Employs standardized root cause analysis, investigational tool, and methodologies. – Take on Majors only moving forward
- Identifies and implements continuous improvement projects to improve yield, reliability, and/or process robustness.
- Writes and implements change controls for the manufacturing area.
- Participate in tech transfer of new products into the facility.
- Provides training and technical development for the manufacturing team.
- Responsible for coordinating activities to support manufacturing (i.e. raw materials and BPR issuance) as needed.
- Ensures manufacturing goals are achieved through robust safety practices and quality compliance.
- Develops and maintains departmental metrics and key performance indicators (KPIs).
- Work closely with Manufacturing and Quality to continually improve all aspects of operations.
- Provide on-the-floor support during manufacturing operations.
- Bachelor's degree with 5 years of progressive experience in roles involving cGMP biologics, cell therapy, and or gene therapy manufacturing
- Expertise in relevant Manufacturing production activities
- Proven ability to effectively plan and coordinate activities based on capacity, priorities, and commitments
- Prior experience in quality investigations and deviation writing in a manufacturing environment is highly desirable.
- Effectively lead and facilitate functional and cross-functional teams
- Thrive working in a highly matrixed, fast-paced, cross-functional team environment
- Capable of influencing without authority, exercising cultural sensitivity, and effectively communicating in a variety of settings
- Ability to prioritize, balance work from multiple individuals, and provide clarity and focus
- Adept in transforming preliminary or ambiguous information, ideas, or problems into well-defined plans and solutions
- Capable of distilling complex business issues into simple problem statements to quickly grasp the scope of the issues, recommend solutions, and drive for resolutions
- Ability to be flexible and adjust plans rapidly to meet changing business needs
- Independently motivated, detail oriented, with strong problem-solving knowledge and capabilities
- Ready and excited to embrace the Resilience phenotype!