The key to our success is our team of dedicated and talented employees, employees that are driven to deliver novel, quality diagnostic products.
Senior Process Chemist (Lyophilization)
Location: San Diego, CA
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 with experience in:
* Developing, set-up, scale-up and optimizing 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.
Research / Manufacturing Technician - PCR
Location: San Diego, CA
We are seeking a motivated and independent molecular biology Research/Manufacturing Technician to support the development of point-of-care molecular diagnostic kits in a demanding, fast-paced environment.
The successful candidate will work closely with other scientists to develop and validate sample preparation methods as well as aid in the optimization of amplification methodologies.
Additional duties may include device testing and verification as well as aiding in the QC process. Attention to detail and the ability to write and follow SOPs is critical.
The ideal candidate will have demonstrated biochemistry and molecular biology expertise and experience with PCR and Real Time-PCR technology.
Experience working with infectious agents in a BSL-2 environment is desired.
* Must have direct knowledge and experience of PCR, real time PCR, DNA sequencing, and formulation of IVD diagnostic products.
· Hands-on experience with PCR assay development and optimization
· Isolation of nucleic acids from a variety of sources
· Direct knowledge of dilution and analytical processes utilized in the manufacture of enzyme solutions.
· Ability to work in a multidisciplinary team environment
· Good communication skills
· Excellent team working and communication skill
· Hands on experience with handling BSL-2 pathogens
* Testing activities including quality control tasks to determine bead and/or strip suitability.
* Able to fill out batch records and follow cGMP compliance.
* Make solutions, formulate assays using volumetric solutions
* Use balances, pipetting equipment, spectrophotometric and pH instruments to make and test solutions.
* Work directly with QA personnel to insure the components meet or exceed product specifications.
* Maintain and set-up documentation and control procedures that meet or exceed ISO 13485 and FDA requirements.
* Develop SOPs, specifications, IQ/OQ/PQ, calibration, and preventative maintenance documents.
· 2+ years previous Biochemistry or Molecular Biology experience and Industrial or CLIA laboratory experience
· Bachelor’s in Biology, or related field
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!
Please email resume to firstname.lastname@example.org