Production Associate, Biologics
Cue Health (Nasdaq: HLTH) is a mission-driven healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India’s Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit www.cuehealth.com.
Cue Health Inc. is seeking to hire a full-time Production Associate, Biologics. Assists with manufacturing techniques and/or methodologies to create products or processes, optimize current products or processes, and supports the transfer and scale up efforts of new products or processes from laboratory development to operations units. Supports the development, optimization, confirmation of processes, and validation and manufacturing of products. Utilizes bio-analytical methods (analytical chemistry, biochemistry, biotechnology, immunology, microbiology, molecular biology, or virology), independently or through collaboration with internal departments or contract labs, to provide analysis and testing support to bioprocessing projects, to aid in troubleshooting biologic quality controls (BioQC) and manufacturing issues, and/or to improve analyses used in products and bring in innovative chemical tests.
Perform manufacturing processes according to GMP documentation
Under supervision, performs QA/QC activities
Exercise considerable judgment and take initiative required to resolve problems and make recommendations
Document experimental data, presenting data, conclusions and interpretations
Follow established protocols and good laboratory practices
Conduct validation studies and shelf life studies as assigned
Review operations documentation for technical content, accuracy, and completion in accordance with GMP
Perform process characterization studies to understand process parameters contributing to acceptable product performance (e.g. mixing studies or incubation time/temperature studies)
Assist with transfer documentation such as material specifications, equipment qualifications, work instructions, and quality control procedures
Modify existing R&D procedures for production purposes (e.g. trehalose solution assay and mitigations for bacterial growth)
Other duties as required
BS degree in Biology, Chemistry, Molecular Biology or related field; MS preferred
2+ years experience in a lab environment for assay development or molecular biology
Proficient in downstream purification using the Unicorn system with AKTA instruments
Experience in process development, validation and implementation
Experience with E. coli-based protein expression a plus
Experience with fermenters and industrial experience are a plus
IVD experience preferred
Knowledge of GMP and GDP lab practices
Excellent verbal and written communication skills
Experience in characterization of proteins by SDS-PAGE, Western blot, Nanodrop, and HPLC
Experience in TFF (ultra-filtration, diafiltration), depth filtration and chromatography is preferred
Environment and Physical Activities/Requirements:
You will work in an indoor laboratory environment, which may occasionally be noisy, subject to climate and humidity requirements, and hazardous substances. This position requires the following physical activities and/or requirements:
Remaining in a stationary or sedentary position, often standing and/or sitting for prolonged periods of time
Moving about to accomplish tasks or moving from one worksite to another, including possibly tight or confined spaces
Reaching, crouching, or stooping
Repeating motions that may include the wrists, hands, and/or fingers
Gross and/or fine manipulation of items with hands and fingers
Adjusting, moving, carrying, lifting, pushing or pulling objects up to 50 pounds
Operating machinery and/or heavy laboratory equipment
Communicating with others to exchange information
Visual acuity (far and near), including peripheral vision
Your contribution will set the pace and have an impact in the technology, health, and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, and a competitive salary.
Cue Health Inc. is an equal opportunity employer, consistent with applicable laws. Individuals seeking employment are considered without regards to race, color, religion (including religious accommodations), creed, sex (including pregnancy, childbirth and related medical conditions), gender (including gender identity and expression), sexual orientation, marital status, national origin (including language use restrictions), ancestry, mental and/or physical disability, medical condition (cancer, genetic information and characteristics, requests for medical and family care leave), age, military or veteran status, and any other classification protected by applicable federal, state, and local laws.
The estimated base compensation range for this role is shown below. This range is based upon current market data and other factors, all of which are subject to change. Individual pay will be determined in accordance with a candidate's location, skills, expertise, background, experience, and other relevant factors. Applicants are always welcome to direct questions regarding this range to the Talent Acquisition specialist recruiting for this position.
Base Compensation Range:$43,500.00 - $72,500.00