Scientist (Sunday - Wednesday)
Production & Laboratory Operations
-Culture and test bacterial spores used in the biological indicator manufacturing process in accordance with cGMPs and approved SOPs
-Execute advanced production activities including:
- Spore inoculation and propagation;
- Agar pour plate preparation and testing;
- Sampling, testing, and data generation
-Prepare, review, and verify batch records and production documentation in accordance with cGDP requirements
-Provide technical support for both new and existing products during routine manufacturing and scale‑up activities
Troubleshooting, Investigations & Technical Support
-Investigate and troubleshoot product deviations, process excursions, and production issues using appropriate scientific and technical diagnostic methods
-Support problem investigations, inspections, and root cause analyses as directed
-Apply standard scientific principles, theories, and concepts to evaluate data, identify root causes, and recommend corrective actions
-Exercise judgment within established practices and procedures when selecting methods and techniques to resolve technical issues
Process Development & Improvement
-Contribute to the origination, design, and execution of experiments, including:
- Development of methodologies;
- Review, analysis, and interpretation of data;
- Preparation of technical summaries and reports
-Support test method development, validation, and optimization activities
-Participate in process improvement initiatives, including Kaizen, 5S, and efficiency projects
Systems & Area Ownership
-Own and manage assigned laboratory or operational systems, including:
- PMs and calibrations oversight;
- Inventory management and SAP transactions;
- Change Orders (COs), Nonconformances (NCs), Laboratory Investigations (LIs), and CAPAs
-Coordinate activities across cross‑functional teams including Quality, R&D, Production Planning, and Manufacturing Engineering
-Maintain clear and complete technical documentation for projects and assigned systems
Training, Leadership & Communication
-Train, coach, and certify junior‑level employees on manufacturing procedures, test methods, and standard work
-Coordinate and manage independent projects under the guidance of process leaders and project facilitators
-Communicate technical risks, business issues, and improvement opportunities to management
-For individuals with supervisory responsibilities, ensure adherence to Health, Safety, and Environmental requirements
Education and Experience Requirements
2–4 years of relevant experience in a regulated laboratory or manufacturing environment; or
0–3 years of experience with a Master’s degree; or
High School Diploma or equivalent with 8+ years of relevant industry experience.
Bachelor’s Degree in Biology, Microbiology, or a related scientific discipline preferred
Required Knowledge & Skills
-Strong knowledge of cGMP and cGDP requirements
-Experience working in an FDA‑regulated environment
-Laboratory experience in aseptic techniques and biologics manufacturing
-Ability to summarize, interpret, and report scientific data
-Proficiency with spreadsheet and database applications
-Effective written and verbal communication skills
-Ability to work collaboratively in cross‑functional teams
Preferred qualifications
- Experience with SAP inventory or laboratory systems
- Experience with statistical tools (e.g., Minitab)
- Yellow Belt or Green Belt certification
- Train‑the‑Trainer or Training Within Industry (TWI) experience
Work Environment & Physical Requirements
- Schedule may include weekend work
- Domestic travel may be required (0–10%)
- Ability to lift 31–50 lbs
- Ability to wear required PPE
- Ability to work in a manufacturing laboratory environment
Integrated Resources
Thermo Fisher Scientific
agcbio
Vagas Grupo Sabin