Our organization is unique in that we are a nonprofit community resource that saves lives by working with volunteer donors to provide the highest quality blood & tissue components to patients. By using cutting-edge technology, our team of dedicated professionals has helped save hundreds of thousands of lives for more than 35 years. Over 200,000 components of life-saving blood and tissue from volunteers throughout South Texas are collected and tested each year. We are internationally recognized for the quality of our services and research. Donors are essential because patients are in constant need of blood, blood components, and/or tissue. It's about life! Share our excitement and join our team!
GenCure, a subsidiary of BioBridge Global, applies advances in regenerative medicine to help heal patients suffering from trauma, disease or the aging process. Using processed tissue and cell-based therapies, GenCure works to connect needs with solutions. GenCure is both a direct supplier to healthcare providers and a partner with commercial and non-profit organizations providing regenerative medicine treatments to patients.
Job Title: Manufacturing Associate III, GenCure
Revision: 0000
Job Code: 704415
Shift: Monday-Friday, 9am - 5pm
FLSA: OT Eligible
Hybrid? N
CPF Level: TB3
Location: San Antonio
Dept.: GenCure Manufacturing
Business Unit: GenCure
General Summary
The successful Manufacturing Associate III 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 III 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 III 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.
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.
Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs. Provide SME knowledge for Manufacturing processes and equipment as assigned.
Demonstrate mastery of equipment by performing troubleshooting. Demonstrate ability to train others on equipment and documentation systems.
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.
Write and revise manufacturing operating procedures as required, promote effective and efficient operations, and comply with cGMP regulations.
Document and maintain activity records according to cGMP regulations and assist in ensuring junior team members are trained.
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.
Support and promote the implementation of Point Kaizens in the facility in conjunction with updating all applicable GMP documentation if required.
Identify areas, documents and processes for improvement and apply Lean Manufacturing / 6S principles for implementation in Manufacturing Operations.
Provide support to QA and MSAT on manufacturing investigations. 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
Six Sigma Green Belt certification preferred
Experience
Requires four or more years of relevant work experience.
If Associate's Degree is attained, requires two or more years of relevant work experience. Requires one or more years of GMP environment experience.
Knowledge
Must have 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.
Must obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies.
Must have a working knowledge and understanding of FDA regulations and current Good Manufacturing Practices (cGMPs).
Must have previous work experience with Microsoft Office, to include Outlook, Word, Excel, Visio and PowerPoint.
Skills
Must be capable of performing, evaluating, and reporting on laboratory systems.
Must maintain competency in laboratory skills for liquid and material handling.
Must be capable of evaluating, interpreting and reporting accurate/valid test results by current testing methodologies.
Must have excellent interpersonal and public speaking skills.
Must have excellent written and oral communication skills.
Must be capable of operating laboratory and/or other job related equipment.
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.
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
GenCure, a subsidiary of BioBridge Global, is proud to be an Equal Opportunity Employer committed to providing employment opportunities to minorities, females, veterans, and disabled individuals. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, genetic data, sexual orientation, gender identity, or any other legally protected characteristics. For more information about your EEO rights as an applicant under the law, please click here. GenCure maintains a Tobacco & Drug-Free Workplace.