BioBridge Global Scientist I in San Antonio, Texas
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 at http://gencure.org/ , 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.
Provide analytical support and cell culture technical expertise for GenCure Biomanufacturing Center (GBC) Process Development and Manufacturing including: analytical methods development and tech transfer, transition of analytical methods for cGMP/QC testing as well as managing relationships with outside vendors and Contract Research and Testing Organizations. This position requires strict attention to detail and high quality customer service skills.
Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE).
Major Duties and Responsibilities
Under guidance of the Process Development Team Lead, with expectations for exercising independent technical judgment, specific responsibilities will include:
Lead efforts in the development and phase-appropriate validation of analytical test methods for the characterization and release testing of cell therapy clinical materials. Independently manage technology transfer of research analytical methods by collaborating with client technical teams. Following approved technology transfer protocols; this person will optimize existing methods and validate them as appropriate for QC release testing. This includes generation of all relevant documentation.
Following FDA GMP regulations and guidelines, this individual will collaborate in the clinical-scale GMP manufacturing, in process testing and QC release testing of cell therapy products. This will include operational scheduling of various activities; including analytical/QC supply procurement, product testing, facility cleaning and environmental monitoring, calibration, preventative maintenance and validation activities.
Manage relationships with outside analytical supply vendors and contract testing laboratories, as appropriate. Establish and maintain relationships with technical representatives concerning testing of clinical trial materials.
This individual will be responsible for authoring all relevant technical reports detailing analytical methods transfer, testing of development batches, preclinical safety/toxicology batches and GMP-grade clinical batches.
Provide cell culture expertise to GBC Manufacturing Team as needed, for cGMP manufacture of Cell Banks, Final Cell Product, Extracellular Vesicles, etc.
- PhD or Master’s degree (minimum of 5 years of experience) in a scientific or engineering discipline is required with experience in mammalian cell culture, analytical cell biology and analytical biochemistry.
Experience in all aspects of mammalian cell culture and stem cell characterization (ELISA, Flow cytometry, PCR, microbiology testing and control, viral testing and control, differentiation, enzyme assays, etc).
Experience in cGMP principles, Quality Management Systems and cGMP analytical testing is desired.
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 maintain a knowledge of cGMP (current Good Manufacturing Practices), cGTP (current Good Tissue Practices), and CLIA regulations.
Must have a specific understanding of two or more of the following subject matter areas is strongly preferred: wound healing biology, bone biology, cell-based therapeutics and/or applied regenerative medicine.
Must have excellent hands-on laboratory skills.
Must have excellent interpersonal and public speaking skills.
Must demonstrate the ability to solve technical and/or clinical problems with biotechnology-based solutions required.
Must be able to commit to project delivery timelines and budget.
Must be able to keep information confidential.
Must be energetic, enthusiastic and 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 maintain a good working rapport with co-workers.
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. 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.
Will sit, stand, walk, and bend during working hours.
Requires manual and finger dexterity and eye-hand coordination.
Required to lift and carry relatively light materials.
Requires normal or corrected vision and hearing corrected to a normal range.
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
• Variable Compensation Plan
• 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
• Shift Differentials
• Group Health Medical Plan w/prescription coverage
• Paid Holidays
• Variety of Voluntary Supplemental Insurances
• Leaves of Absence
• Voluntary Dental Coverage
• Educational Assistance Program
• Voluntary Vision
• Professional Development Plan (PDP)
• 100% Employer Paid Pension Plan
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 at http://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf . GenCure maintains a Tobacco & Drug-Free Workplace.