Senior Lyophilization Process Chemist
Mesa Biotech is a fast growing, ISO certified, FDA approved, medical device company that has achieved a dramatic simplification in the complexity of DNA and RNA molecular testing. Our patented technology provides everything needed to conduct rapid molecular tests at the point-of-care. The palm-sized, reusable dock and disposable test cassette form a user-friendly system for use anywhere, from the physician’s office to the patient’s home.
We are seeking a motivated and independent Senior Lyophilization Process Chemist who will be responsible for developing, scale up and optimizing the dispensing and lyophilization process. Accountable for producing critical product components to include lyophilization, dispensing process and chemical formulation to achieve successful manufacturing of robust diagnostic products. This position is responsible for set up, scale up and performance optimization of large scale Bioreagent lyophilization components and processes to achieve highest quality and efficiency. Participates in day-to-day operations with responsibilities in optimizing manufacturing process improvements, validation and cost optimization, quality testing, inventory management and labor accountability.
We are looking for someone who has experience in:
- Develop, set up and scale up and optimize formulations, and manufacturing processes.
- Develop the operating protocols and documents that meets ISO 13485 and cGMP standards.
- Support the implementation of automation processes to improve manufacturing throughput.
- Adhere to the OSHA safety code and company policies
- Work directly with QA personnel to support ISO 13485 and cGMP certification.
- Lead and develop capacity plan to support production requirements and meet R&D and commercial needs.
- Support internal and external audits when necessary.
- Training junior manufacturing personnel to implement efficient manufacturing work flow
- Equipment Management (Specifications, IQ/OQ/PQ, Calibration and Preventive Maintenance)
You will need to have:
- Bachelor’s degree plus a minimum of 8 years of experience in an in-vitro diagnostic industrial setting.
- Direct knowledge of manufacturing processes.
- Thorough understanding of dispensing processes.
- Direct knowledge of lyophilization, conjugation, formulation of IVD diagnostic products.
- Thorough knowledge of cGMP requirements to ensure adherence to compliance policies and regulations.
- Through knowledge of ISO 13485 regulations and certification.
- Ability to perform project management activities and lead small teams.
- Thorough knowledge of non-conforming material, corrective and preventive action processes
- Knowledge on how to perform process investigations per FDA and ISO standards
- Knowledge of risk analysis per FDA and ISO standards
- Ability to read, write and speak English.
- Experience in setting up, operate, and maintain large scale lyophilizers
- Strong written and oral communication skills.
- Demonstrates team working competencies and ability to lead the project to meet production schedules.
We offer a competitive salary, comprehensive benefits including: medical, dental, vision, flex plan, life/disability insurance, 10-paid holidays, 15-days PTO and a 401(k) plan.
If you like the start-up environment, have a problem driven mindset, want autonomy working for an innovative company; get ready to roll-up your sleeves and join our team of collaborative people!