The Opportunity
Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
The position of Bioconjugation Chemist II is within our Toxicology business unit located in Pomona, California. This position is responsible for technical manufacturing operations and performing laboratory analytical tasks.
The Chemist will support Technical Operations (Manufacturing) and / or Design Development as required. This position is a key member of the Bioconjugation Chemistry Laboratory.
What You’ll Work On
- Follows SOP and batch records for conjugation of small molecules to enzymes, proteins and peptides for production of reagents for ELISA, HEIA, SEFRIA and LFIA diagnostic product platforms.
- Performs purification of enzyme conjugates for ELISA, HEIA, SEFRIA and LFIA using gel filtration chromatography, dialysis and HPLC techniques.
- Performs in-process performance testing of enzyme conjugates for ELISA, HEIA and SEFRIA platforms using absorbance readers and chemistry analyzers.
- Assists in qualification and transfer of analytical methods from R&D to technical operations, including assay execution and preparation of reports as required.
- Analyzes and maintains data per applicable SOPs.
- Documents activities in a cGMP manner.
- Performs investigation and resolution of out-of-spec events
- Prepares buffers, reagents, and solutions as necessary to conduct analyses.
- Performs routine maintenance of laboratory equipment
- Performs daily temperature monitoring.
- Works as part of inter-departmental teams as required
- Demonstrates commitment to the development, implementation, and effectiveness of the Company Quality Management System per ISO, FDA, and other regulatory agencies.
- Understands and is aware of the quality consequences that may occur from the improper performance of their specific job;
has awareness of device defects that may occur in their area of responsibility, including product design, verification, validation, manufacturing, and testing activities.
Responsible for exhibiting professional behavior with both internal / external business associates that reflects positively on the company and is consistent with the company’s policies and practices;
builds productive internal / external working relationships.
- Carries out duties in compliance with established business policies.
- Other duties as assigned, according to the changing needs of the business.
Required Qualifications
- B.S. in Chemistry / Biochemistry / Biology with 2-5 years of experience in a laboratory OR M.S. in Chemistry / Biochemistry and 1-3 of related experience.
- Previous work experience in a chemical diagnostics laboratory position.
- Previous work experience in a cGMP environment.
- Strong verbal and written communication skills.
- Proficient with Microsoft Windows and Excel, Word, PowerPoint, andAccess.
- Pipetting and sample handling.
- Using scientific notation to convert units of mass, volume, and molarity.
- Knowledge of Database and laboratory software.
PREFERRED QUALIFICATIONS :
- Product knowledge in medical devices or diagnostics.
- Ability to work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
- Experience in exercising judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.