- Communication Skills
- Data Collection
- FDA Regulations
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 BioProcess 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 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.
Lead contributor in late stage process development for transferring new products and processes to manufacturing
Selection of appropriate components and equipment based on analysis of specifications reliability and regulatory requirements for aseptic manufacturing
Identify, implement and develop equipment to support scale up of internal manufacturing of intermediates.
Analyze equipment to establish operating data, conduct experimental test and result analysis.
Ensure that all activities are completed and documented in accordance with procedures
Support development of systems for equipment calibration, certification and qualification and ensure compliance with systems, including MSA studies.
Participate in PFMEA and other process risk based process evaluations.
Designing and executing equipment and process qualifications and validation studies and implementation of new processes and products.
Drafting equipment and materials specification, operating SOPs, Work Instruction and provide training for manufacturing team members.
Ensure quality of process and product as defined in the appropriate equipment operation and material specifications
Support manufacturing facility development, buildout, commissioning and qualification.
Support development of relevant manufacturing metrics, data collection, reporting and process improvements.
Support the development of regulatory CMC documentation.
Work with the Quality organizations as necessary to help investigate any excursions, deviations, CAPAs, etc and develop appropriate corrections.
B.S. Degree in biomedical engineering, chemical engineering, or similar related field required.
A minimum of 5 years in biopharmaceutical manufacturing engineering / development required.
Knowledge of FDA, GMP and ICH requirements
Proven experience in improving quality and scaling up / out manufacturing processes and systems to support biopharmaceutical development.
Experience with process development for Biologics, cell based therapies, and/or Advanced Technology Medicinal Products preferred.
Strong communication skills with the ability to effectively work cross-functionally and externally as required.
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