Scientist , Manufacturing Science & Technology

Responsible for successfully transferring processes into GMP-compliant Production from Process Development to Commercial Manufacturing including creation and/or revision of technical documentation and execution of defined processes. These may include analytical methods, technology transfers and cGMP manufacturing. This position requires strict attention to detail, high quality customer service skills and the ability to work collaboratively within a project team.

Commit to and abide by the character of Bio Bridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE). Support, communicate and reinforce the mission and vision of the enterprise.

Provide world class customer service by capturing and being responsive to the voice of the customer (internal or external, including donors for select positions) through multiple feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes.

• Develop, draft, revise training documents, validation/verification plans, test cases, validation/verification summaries and review completed validations.
• Collaborates with operational unit SMEs in developing and drafting production documents, e.g. policy, standard operating procedures (SOPs) work instructions, forms, job aids, Master Batch Records, material product specifications.
• Ensure on‑time delivery/readiness of technology transfer (TT) campaigns, collaborating with cross‑functional teams and clients.
• Develop strategies to ensure all production-readiness requirements are met.
• Communicate with stakeholders to ensure all biomanufacturing requirements are met.
• Lead, manage and oversee designated activities for cGMP-compliant analytical testing and cGMP/Clinical‑scale Manufacturing including aseptic processing/manufacturing in the clean rooms as needed.
• Provide technical expertise and problem‑solving support.
• Identify areas of improvement and develop solutions.
• Ensure compliance with all change control procedures, regulatory standards and industry best practices.
• Collaborates with Quality Assurance SMEs to produce and maintain documents supporting the Quality Systems as they pertain to BBGAT Process Development and Manufacturing, e.g. Quality investigation Reports/ CAPAs, Validations, Risk Assessments/FMEAs.
• Develop, draft, revise scientific communications such as abstracts, case studies, book chapters, white papers and journal articles to advance BBGAT Biomanufacturing capabilities.
• Submit scientific communications to local and national conferences for poster and podium presentations.
• Demonstrate:
  Respect for co‑workers and management staff Excellent customer service [for both internal and external customers] Adherence to all safety, regulatory, and quality requirements Continuous improvement

Performs other duties as assigned.

• Assist in other recruitment areas as directed.
• Administrative support.
• Mentoring and training.
• Collaborative projects.
• Efficiency improvements.

Requires a Bachelor’s Degree from an accredited college or university with major course work relative to the field of assignment.

Prefer a Master’s Degree from an accredited college or university.

• Valid United States Driver’s License.

• If Bachelor’s Degree is attained, three or more years of experience in regenerative medicine or biomanufacturing exclusive of academic experience.
• If Master’s Degree is attained, requires two or more years of experience in all aspects of human cell culture and/or analytical testing relevant to…