BBG Advanced Therapies is a full-service biomanufacturing organization that delivers comprehensive, cell and cell-based manufacturing solutions for advanced therapies. Leveraging its showcase facility designed to be compliant with FDA, EMEA, and PMDA production requirements, BBG Advanced Therapies focuses on translating and refining early-stage processes to scale for commercial readiness.
Job Title: Manufacturing Associate I, BBG Advanced Therapies Manufacturing
Revision: 0001
Job Code: 704410
Shift: Day Shift
FLSA: OT Eligible
Hybrid? N
Dept.: BBG Advanced Therapies Manufacturing
Business Unit: BBG Advanced Therapies
CPF Level: TB2
General Summary
The successful Manufacturing Associate I will be an integral part of the GenCure GMP Manufacturing team. They will be responsible for all phases of Allogenic and Autologous GMP operations in the GMP Manufacturing suite.
The Manufacturing Associate I will be required to maintain knowledge of all current Standard Operating Procedures (SOPs) required to perform effectively.
They will ensure all products are processed in accordance with all relevant SOPs and governing regulatory standards.
The major duties for the successful candidate include maintaining accurate records and documentation as well as resolving discrepancies.
Maintaining excellent communication with the department and throughout the organization is paramount for the Manufacturing Associate I to excel in their role.
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.
It is essential that the incumbent have a valid driver's license and be at least 18 years old with a good driving record to meet organization driving standards.
Major Duties and Responsibilities
Essential Tasks
Perform process unit and support operations described in standard operating procedures (SOPs) and batch records including media and solution preparation; drug substance preparation; and drug product fill operations.
Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc.
Perform accurate and timely completion of documentation required by protocols, SOPs, and batch records.
Maintain aseptic technique during processing of products to ensure the integrity, viability and sterility of cell therapy products from vial thaw to final formulated drug product cryopreservation.
Perform tasks in a manner consistent with safety policies, quality systems, and cGMP regulations. ? ??
Timely completion of training assignments to ensure the necessary technical skills and knowledge are applied compliantly during GMP operations.
Assist in setting up manufacturing areas and equipment, including complex automated cell processing, cell expansion and filling equipment.
Assist in updating and revising manufacturing operating procedures as required, promote effective and efficient operations, and comply with cGMP regulations. ? ??
Document and maintain activity records according to cGMP regulations. ? ??
Routinely monitor, clean, prepare and operate processing and analytical equipment in Grade B/C areas. Follow all cleaning and gowning procedures for the facility.
Perform error free calculations of media component and cell concentration, dilution, viability during production.
Must maintain and apply knowledge regarding donor information, screening and testing, labeling and product acceptability and release criteria.
Maintain the confidentiality of proprietary company information.
Be flexible and adaptable to schedule and procedural changes to ensure timely preparation of products with highest quality.
Maintain current inventory of supplies kept in specified kitting and staging areas and cell culture processing suites.
Performs other duties as assigned.
Education
Requires a high school diploma or GED and specialized or technical training.
Prefer sixty (60) hours from an accredited college or university or Associate Degree from an accredited college or university.
Preferred degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field.
Licenses and/or Certifications
Biotechnology certification preferred Valid United States Driver's License
Experience
Requires one year or more of job related experience.
Prefer GMP experience.
Prefer Aseptic Processing in Grade A/B Biosafety Cabinets experience.
Knowledge
Must obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies.
Must have previous work experience with Microsoft Office, to include Outlook, Word, Excel, Visio and PowerPoint.
Must obtain a working knowledge and understanding of FDA regulations and current Good Manufacturing Practices (cGMPs).
Must obtain a working knowledge in all aspects of technical procedures of a clinical laboratory.
Must recognize and facilitate resolution of unusual results or difficulties encountered in all phases of laboratory work.
Skills
Must be capable of operating motor vehicles in all @types of weather conditions.
Must maintain competency in laboratory skills for liquid and material handling.
Must be capable of operating laboratory and/or other job related equipment.
Must be capable of performing, evaluating, and reporting on laboratory systems.
Must be capable of evaluating, interpreting and reporting accurate/valid test results by current testing methodologies.
Must have excellent written and oral communication skills.
Must have excellent interpersonal and public speaking skills.
Abilities
Must be able to keep information confidential.
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 have the ability to establish and maintain effective relationships with the general public, employees and management staff.
Must have the ability to meet time deadlines, connect and interrelate disparate ideas and thoughts, pay attention to detail, and work effectively with varying constituencies.
Working Environment
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.
Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
Ability to wear personal protective equipment including safety goggles, sterile gown, head cover, mask, safety shoes and gloves.
No makeup or jewelry can be worn when working in the cleanroom environment.
Will work extended hours during peak periods. May be required to work any time of the day, evening or night during the week or weekend.
Occupational Exposure Assignment-Category I
Physical Requirements
Requires manual and finger dexterity and eye-hand coordination.
Will require walking, bending, and prolonged sitting and/or standing during work hours.
Required to carry up to 25 lbs. and occasionally lift up to 50 lbs.
Requires normal or corrected vision and hearing corrected to a normal range.
Requires ability to work with onsite equipment and observing work processes.
Must be able to drive on behalf of the organization.
We invest in our people by offering competitive compensation, excellent benefits, and the opportunity to work with the first blood center in America to receive the ISO 9002 accreditation!
All Full Time Positions Qualify for an Affordable and Competitive Benefits Package to include:
Competitive salary
100% Employer Paid Life Insurance
401(k) with Employer Contribution
100% Employer Paid Long-term Disability Plan
Paid Time Off (PTO)
100% Employer Paid AD&D
Extended Illness Benefits (EIB)
100% Employer Paid Employee Assistance Program
Incentive Compensation Plan
Group Health Medical Plan with prescription coverage
Shift Differentials
Variety of Voluntary Supplemental Insurances
Paid Holidays
Voluntary Dental Coverage
Educational Assistance Program
Voluntary Vision
BBG Advanced Therapies, a subsidiary of BioBridge Global, is proud to be an Equal Opportunity Employer committed to providing employment opportunities. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. For more information about your EEO rights as an applicant under the law, please click here . BBG Advanced Therapies maintains a Tobacco & Drug-Free Workplace.
