3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow replacement of each individual patient's parts with tissues designed and created specifically for them. 3DBio has developed unique capabilities toward the creation of living tissue implants for therapeutic applications. The technology platforms include a full suite of features to meet the FDA's requirements for therapeutic manufacturing, including novel and proprietary: 3D-bioprinter (GMPrint™), bio-ink (ColVivo™), and cell processes. In pre-clinical studies the platform has demonstrated the ability to generate functioning living tissues.
The Senior Process Engineer will be responsible for the development and scale up of internal manufacturing processes to support the growth and advancement of 3D Bio's regenerative medicine products as well as supporting development and engineering activities associated with outsourced manufacturing.
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 develop and scale processes, equipment and packaging in support of 3D Bio's regenerative medicine products.
Work with Development to ensure appropriate equipment and processes are used for internal manufacturing.
Identify, implement and develop equipment to support scale up of internal manufacturing of intermediates.
Manage, directly or via peer leadership, junior process engineering staff. Ensure that staff goals are clear, and issues are identified and addressed or escalated as necessary.
Identify / develop appropriate primary and shipping packaging for biological tissues and products. Manage external packaging vendors, as appropriate.
Provide support for manufacturing facility development, buildout, commissioning and qualification. May include management of contractors involved in these activities.
Support development of systems for equipment calibration, certification and qualification and ensure compliance with systems.
Support development of relevant manufacturing metrics, data collection, reporting and process improvements.
Support the development of regulatory CMC documentation and partner due diligence.
Work with the Quality organizations as necessary to help investigate any excursions, deviations, CAPAs, etc and develop appropriate corrections.
Stay current with current industry standards, new trends and all applicable regulations.
Develop and maintain external relationships with subcontractors, and service providers.
A minimum of 10 years in biopharmaceutical manufacturing engineering / development.
Degree in biomedical engineering, chemical engineering, or similar related field required.
Proven experience in improving and scaling up / out manufacturing processes and systems to support biopharmaceutical development.
Experience with the development of Biologics, cell based therapies, and/or Advanced Technology Medicinal Products preferred.
Results oriented: Ability to meet develop expectations and priorities, and meet clear goals. Flexible and creative problem-solving skills.
Strategic Thinker: Can see the big picture, able to constantly think ahead about ways to do things better. Thinks logically, develops and evaluates options, identifies pros and cons. Able to challenge current processes, practices and strategy and uncover alternative approaches, solutions or methods.
Peer leader: Proven track record of supporting, and preferably leading, high performance cross-functional teams. Experience delivering results in a small, fast paced organization.
Communicator: Excellent communication and interpersonal skills with success in working across organizational boundaries at all levels to bring together people of diverse backgrounds and skill-sets to create, influence and negotiate win-win solutions.
Strong interpersonal skills: Has the ability to motivate others, influence without authority, and navigate conflict situations. Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
Self-directed: Individual who is able to work effectively with limited direction in a complex, fast-paced environment.
To learn more about 3DBio, please visit our website: https://3dbiocorp.com/