Location: Jupiter, FL
Reports To: CSO
Reporting to the CSO, the Lab Operator executes the Company’s enzyme manufacturing projects according to customer-driven timelines and internal prioritization. We are seeking a highly motivated Lab Operator to join the Fermentation Team in pursuit of maintaining production schedules. As an integral member of the team, the successful candidate will focus on operating and maintaining the equipment used in the manufacturing of protein enzyme products in compliance with the FDA’s 21 CFR 211/820 design control requirements. She/he is an experienced scientist with outstanding organizational skills and an attention to detail. The ability to follow SOP’s while maintaining a real-time electronic notebook are crucial skills for a successful candidate. Alphazyme maintains a commitment to Quality and a culture of continuous improvement, the Lab Operator shall periodically recommend efficiency improvements to the Company’s development process team and management.
Job performance will involve a variety of activities including:
- General operations such as bioreactor building/sterilization, cleanup and turnover of bioreactors to maintain a set run schedule
- Offline sample analysis including: Optical Densities, Cell counting, and metabolite analysis
- Collaborate with multiple areas to execute data mining efforts in support of long-term project management
- Maintain records and test results following strict manufacturing guidelines
- Work independently and efficiently
- Document work clearly and perform procedures accurately
- Work well with other team members
- Work will include periodic evening and/or early morning weekday hours as well as periodic weekend hours
- Communicate results at team meetings, contribute to project and experiment planning
- Follow SOP and WI protocols, operational processes, and safety best practices
- Follow safety, quality control and quality assurance procedures
- Identify technical issues, troubleshooting, solve problems and achieve clear resolution
- Maintain laboratory documentation in accordance with applicable scientific, regulatory, and intellectual property requirements
- Maintain clean work areas and equipment
- Perform Preventative Maintenance schedules with supervision as needed
- Other duties as needed
- Bachelor’s/Masters Degree in Microbiology, Biochemistry, Chemical Engineering or related field is preferred.
- Some industrial experience is preferred.
- Must have excellent sterile technique.
- Ability to record data, compile, analyze and communicate results is required.
- Ability to manage and prioritize multiple projects within a fast-paced environment.
- Exceptional attention to detail and passion for problem-solving.
- Ability to work a flexible schedule, as required, to meet development and maintenance scheduling needs.
- Excellent organizational, interpersonal and communication skills.
- Team player, results oriented and able to work in multidisciplinary teams.
- Creativity, strong problem solving and critical thinking skills.
- Computer skills (Proficiency with MS Word, PowerPoint, Excel, and Access is expected).
- Experience in a Good Manufacturing Practice (GMP) or ISO 13485 environment is desired.
- Ability to organize tasks and work cooperatively; ability to communicate effectively orally and in writing; ability to use science literature and reference texts; ability to keep accurate records; ability to work safely.
- Minimum Bachelors of Science with two years industry experience, or Masters/PhD degree with an emphasis on: Microbiology, Biotechnology, Biology, Bioprocessing or related fields.
Alphazyme was founded in 2018 by experts in the field of enzyme development and production with a track record of success and a passion for supporting innovators in molecular science. Our mission is to be the world’s premier partner for custom, industrial-scale molecular biology enzymes. We partner with the manufacturers of nucleic acid therapies and detection platforms to develop and produce affordable, reliable enzymes which meet the specifications of the rapidly expanding market for custom DNA and RNA molecules, genomic medicines and genetic tests. Consistent quality, scalable production, and compatibility with regulatory requirements are the hallmarks of our business.