Scientist I, Manufacturing Science & Technology

General Summary
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 BioBridge 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.

Major Duties and Responsibilities

Essential Tasks

• 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 cleanrooms 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.

Non-Essential Tasks

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

Required Minimum Education
Requires a Bachelor’s Degree from an accredited college or university with major course work relative to the field of assignment. Preferred Education
Prefer a Master's Degree from an accredited college or university. Licenses and/or Certifications

• Valid United States Driver’s License. Experience

Required Minimum Experience

• 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 regenerative medicine or biomanufacturing.• If Ph.D. is attained, requires some experience in all aspects of human cell culture and/or analytical testing relevant to regenerative medicine or biomanufacturing.• Experience may be inclusive of academic training. Preferred Experience

• Prefer experience in cGMP principles, Quality Management Systems and cGMP analytical testing. Experience Exception to Education
In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge


Knowledge

• Must have a specific understanding of the following subject matter areas is strongly preferred: cell biology analytical development, human cell culture, process engineering.• Must have a working knowledge of tissue and cell culture.• Must maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies.• Must maintain familiarity of regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc.• Must have a working knowledge and understanding of FDA regulations and current Good Manufacturing Practices (cGMPs). Skills

Skills

• Must demonstrate the ability to solve technical and/or clinical problems with biotechnology-based solutions required.• Must have basic library and literature-based research skills.• Must have excellent written and oral communication skills.• Must have excellent interpersonal and public speaking skills.• Must be capable of evaluating, interpreting and reporting accurate/valid test results by current testing methodologies.• Must maintain competency in laboratory skills for liquid and material handling.• Must have strong computer skills.• Must be capable of operating motor vehicles in all types of weather conditions.• Must have experience biological laboratory benchtop techniques Abilities

Abilities

• Must be able to conduct experiments and correctly interpret test results.• Must be able to develop operational schedules of various activities; including raw materials procurement, tech transfer activities, process development activities, manufacturing events, and product testing.• Must be able to train and supervise junior staff.• Must have a team‐oriented leadership style.• Must be neat in appearance and well groomed.• Must be professional, detail oriented, self-motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently.• Must be able to keep information confidential.• Must be a self-starter and self-directed worker.• Must be able to meet deadlines, and perform accurate laboratory testing.• Must perform well in repetitive work situations.• Must be able to work independently as well as in a team environment.• Must be able to present data to management. Working Environment & Travel Requirements


Working Environment & Travel Requirements
Works in a well-lighted air conditioned and heated laboratory/department. May be exposed to electrical, mechanical and chemical hazards and other conditions common to a laboratory environment. May be exposed to blood borne pathogens and other conditions common to a clinical laboratory environment. May have bodily exposure to refrigerator/freezer temperature, especially hands and face. May be required to work any time of the day, evening or night during the week or weekend. Occupational Exposure Assignment - Category I Travel Requirements
Ability to use personal motor vehicle for company business required. Physical Requirements

Physical Requirements
Must be able to drive on behalf of the organization. Will sit, stand, walk, and bend during working hours. Required to carry up to 25 lbs. and occasionally lift up to 50 lbs. Requires manual and finger dexterity and eye-hand coordination. Requires normal or corrected vision and hearing corrected to a normal range. Will be required to stand for a long period of time. Requires the ability to sit for long periods of time. Requires ability to work in confined or tight spaces.