The Manufacturing Associate will be responsible for the development of manufacturing documentation and performance of internal manufacturing operations to support the growth and advancement of 3D Bio’s regenerative medicine products. This individual may also provide support to other groups such as Quality Control, Quality Assurance and Research & Development.
This position will report to the Director of Manufacturing and will will work closely with key stakeholders including Development, Quality, Manufacturing and external manufacturers to perform and document processes, support GMP facility operations and upkeep and maintain cGMP compliance.
Responsibilities to include:
- Work with Development to implement and document appropriate equipment and processes used for internal manufacturing.
- Perform internal manufacturing, testing, labelling and packaging of intermediates. Serve as primary operator or as secondary verifier.
- Perform monitoring of facility, equipment and utilities to ensure uninterrupted operations.
- Ensure clear, documentation of all activities in accordance with current Good Manufacturing Practices.
- Identify any issues and escalate to leadership and Quality Assurance. Work with leadership and team to address issues in a timely fashion.
- Support the ordering, handling, labelling and documentation of raw materials used for manufacturing of internal products.
- Provide support for manufacturing facility development, buildout, commissioning and qualification activities.
- Support development and perform equipment calibration, certification and qualification, as appropriate, and maintain compliance with systems.
- Support the compilation manufacturing metrics, data collection, reporting and process improvements.
- Provide support to other groups as requested by leadership.
- Work with the Quality organizations as necessary to help investigate any excursions, deviations, CAPAs, etc and develop appropriate corrections.
- Stay current with company SOPs, batch records and industry standards, and all applicable regulations.
- 2-5 years in aseptic biopharmaceutical manufacturing, preferably in biologics / cell therapies.
- Degree in biology, biomedical engineering, or similar related field.
- Attention to detail and ability to develop and follow clear written documentation.
- Strong ethical foundation
- Experience with the aseptic operations and/or manufacturing of Advanced Technology Medicinal Products preferred.
- Results orientation: Ability to meet clear goals and expectations and identify deviations / non-conformances from written requirements. Flexible and creative problem-solving skills.
- Teamwork and Peer Support: Able to work on high performance cross-functional teams and deliver results in a small, fast paced organization.
- Communications: Excellent oral and written communication and interpersonal skills and the ability to work communicate well with all levels and diverse backgrounds.
- Strong ethical base: Comfort with identifying and communicating issues quickly and supporting resolution to ensure the safety of patients.
- Self-directed: Individual who is able to work effectively with limited direction in a complex, fast-paced environment.