QC Associate II (Chromatography)

At Genentech, we are passionate about improving patients' lives and creating healthier communities for all. We foster a culture of inclusivity, integrity, and creativity while boldly pursuing answers to the world's most complex problems. We believe diversity and inclusion drives innovation and contributes to equitable healthcare access for all. At Genentech, different backgrounds and perspectives are essential. We believe every employee makes a difference. 

The focus of Oceanside Operations is Drug Substance bulk manufacturing. We have a passion for science, technology, innovation, professional development, and diversity and inclusion. Our vision is to have a greater overall impact and benefit to the patient. We hope you consider joining our team and being part of one of the best biotechnology facilities in the world.

The Opportunity

Genentech is looking for a Quality Control Associate II in Oceanside, California.  This position is primarily responsible for sample management, reagent preparation, compendial method testing, and Bulk Drug Substance testing for biopharmaceutical products. Additional responsibilities include equipment management and maintenance, and laboratory duties.

Job Responsibilities

• Proficient in GMP, GLP, GDP, and Data Integrity

• Prepare reagents to support routine testing

• Perform routine compendial testing (pH, osmolality, color) per SOPs and GMP

• Perform Bulk Drug Substance testing (HPLC, UPLC, Potency)

• Perform sample management and aliquoting

• Perform chemical assays according to established procedures

• Perform inventory checks and stock laboratory supplies as needed

• Maintain laboratory in an inspection ready state

• Perform laboratory equipment maintenance

• Perform calibration and standardization of equipment

• Able to work independently with little supervision

• Follow established safety and environmental guidelines and procedures for all work performed

Supplementary Responsibilities

• Act as designee in cross-site and/or interdepartmental meeting

• Facilitate team meetings as required. Attends department and corporate meetings

• Attends seminars and/or classes to enhance technical or professional skills

Who you are

Education and Experience

• Bachelor’s Degree in Biology, Microbiology, Biochemistry, Chemistry or other relevant discipline

• 5-6 years of related experience  

Knowledge, Skills, and Abilities 

• Advanced knowledge and experience with Liquid Chromatography preferred

• Basic knowledge of Gas Chromatography preferred

• Knowledge of Empower, GSMP, and Other Software

• Excellent interpersonal, written and verbal communication skills

• Must be agile and able to work independently in a fast paced environment

• Proficient in time management with little to no oversight

• Experience in audits and inspections with presenting topics to auditors

• Computer skills – LIMS, Microsoft Office, Google Workspace 

Work Environment/Physical Demands/Safety Considerations

• Work in office and laboratory environment

• Able to stand, sit, and walk for extended periods of time

• Able to lift up to 30lbs

• Work with analytical instruments that may involve exposure to hazardous chemicals (corrosive, toxic, flammable, etc)

• Ability to perform repetitive tasks including frequent hand and finger manipulations, grasping pushing and pulling

• Available to work over-time, weekends, and holidays as needed

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of California is $66,200 (min) - $94,500 (mid) - $122,900 (max) annual.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.