X-Therma technology greatly improves cold-chain logistics and is an FDA Breakthrough Device to end the organ waiting list in a long-overlooked market. This is a paradigm shift that could make worldwide organ sharing possible and eliminate organ discard. Immediately, the technology could resolve current bottlenecks in Regenerative Medicine biomanufacturing and processing and allow “off-the-shelf" living medicines in this hyper-growth space.
To strengthen our growing team in Hercules, we are looking for anAnalytical Chemist to ensure the quality and integrity of our molecules and processes by conducting analytical tests and experiments.
What’s in it for you?
What you will do:
- Design and develop analytical methods for the analysis of live-saving molecules
- Validate and optimize processing methods and recommend alternatives and suggestions to ensure accuracy, precision, and reliability.
Sample Analysis:
- Perform routine and non-routine analyses from samples from various sources to provide information on compounds or quantities of compounds present.
- Ensure adherence to quality control standards and regulatory requirements.
Data Analysis and Recording:
- Analyze and interpret analytical data, preparing detailed reports for internal and external stakeholders.
- Maintain detailed records of results which may include collecting, extracting, and entering data via both electronic and paper files (i.e., notebooks, logbooks, batch records, etc.)
- Collaborate with cross-functional teams to communicate findings and contribute to decision-making processes.
Instrumentation:
- Perform instrumentation techniques such as gas chromatography (GC), high performance liquid chromatography (HPLC), ion chromatography, electrochromatography, liquid chromatography-mass spectrometry (LC-MS) and spectroscopy (infrared and ultraviolet, amongst others), to investigate chemical compositions.
- Troubleshoot instrument issues and coordinate with the maintenance team for repairs.
- Calibrate and maintain laboratory instruments and equipment in accordance with standard operating procedures (SOPs) to ensure accuracy and reliability of test results.
Quality and Quality Control:
- Conduct a variety of tests and analyses on raw materials, intermediates, and finished products using standard laboratory techniques and equipment.
- Perform quality control of final compounds and solutions in accordance with established specifications.
- Contribute to quality assurance programs by participating in audits, maintaining documentation, and ensuring compliance with relevant standards.
- Contribute to quality assurance programs by preparing MBRs, SOPs, and other documentation.
Research and Development:
- Validate methods and equipment for regulatory agency submission
- Stay abreast of industry trends and advancements in analytical techniques.
- Collaborate with R&D teams to support the development of new products or improvements to existing ones.
- Master’s degree in Analytical Chemistry, Chemistry, or a related field. Ph.D. is a plus.
- 2+experience in analytical method development and validation.
- Proficiency in operating and troubleshooting analytical instruments.
- Strong analytical and problem-solving skills.
- Excellent communication and teamwork abilities.
- Familiarity with GMP regulatory requirements and quality assurance standards.
- Prior responsibility for developing technical SOPs, Batch Production Records (BPR) and technical reports is a plus
- Competitive base salary: $88,000- $95,000 per year
- Employee Stock Option Plan
- Health, vision, and dental benefits
- 401(k) savings plan
- 5-Day marriage leave policy
- And more!
X-Therma is an Equal Opportunity Employer. X-Therma does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.