BioMarin Pharmaceutical Inc.
(CW) QC Quality Control Analytical In-Process (TEMPORARY)
BioMarin Pharmaceutical Inc., Novato, California, United States, 94949
Who We Are
BioMarin Pharmaceutical Inc. is a company founded in 1997 and based in San Rafael, CA that specializes in the development of therapeutics for serious and often life‑threatening rare diseases. The company has become the first to commercialize treatments for mucopolysaccharidosis (MPS) and phenylketonuria (PKU). The Quality Control Process Monitoring group works in tandem with the manufacturing suites at the Novato, CA production facility to evaluate how well all major stages meet their quality parameters and ensure consistency of each final product line.
Contract Role Details Shift: 4×10. Sunday–Wednesday but may change due to business need (Shifts are Sunday–Wednesday Day (0700‑1800) / Swing (1300‑0000) or Wednesday–Saturday Day (0700‑1800) / Swing (1300‑0000)). Pay: up to $27 per hour.
Position Overview The Quality Control Analytical In‑Process (QCA‑IP) Analyst performs analytical test methods on in‑process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines to support the manufacturing of commercial and clinical therapeutics. The role involves protein determination (A280, Bradford, UV absorbance), enzyme activity, HPLC/UPLC, and method validation.
Key Characteristics and Functional Activities
Perform a wide variety of analytical assays and maintain test sample throughput.
Monitor lab supplies, prepare reagents, and contribute to process and method validation studies.
Support investigations, equipment validation, and brainstorm further development or improvement ideas for procedures.
Work Assignments and Expectations Employees are expected to follow SOPs, make appropriate decisions with minimal intervention, recognize deviations from routine practices, and accurately complete tasks on time to achieve lab goals while limiting GMP/procedural errors. They must interpret results against defined criteria, apply critical thinking, and provide troubleshooting as a trainer. Effective time management, prioritization, proactive communication, and a positive attitude are essential.
Responsibilities
Timely facilitation of incoming sample receipt and accessioning flow, deciphering batch assignments across all assay types.
Execute analytical methods to facilitate in‑process testing under applicable cGMP guidelines.
Evaluate completed assay validity, calculate and summarize results, and assist with trend analysis reports.
Perform housekeeping activities and ensure systems for laboratory maintenance are adequate.
Monitor and control laboratory supply and critical reagent inventories.
Qualify as a trainer for specified methods and provide training to less experienced staff.
Communicate compliance risks and deviations, initiate investigation records within required timeframes.
Provide input or assay support for test method validation, investigations, technical studies, and method transfer protocols.
Attend team huddles and department meetings, generating ideas for laboratory infrastructure improvements and method optimization.
Perform other responsibilities as deemed necessary.
Qualifications
Bachelor of Science degree.
0–3 years of relevant laboratory experience; QC-specific experience preferred.
Experience with quality management systems, current Good Manufacturing Practices, and QC principles.
Demonstrated knowledge of certified functional activities.
Good documentation, written and verbal communication skills.
Ability to perform most tasks with minimal supervision.
Computer literacy with proficiency in Microsoft Word and Excel; experience with PowerPoint preferred.
Quality service attitude, flexibility, and willingness to work additional hours.
Note This description is not intended to be all‑inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Statement An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Salary & Benefits In the U.S., the salary range for this position is $15 to $30 per hour, with the base pay determined by internal equity and may vary depending on candidate's experience, qualifications, and geographic location. The role may also be eligible for a discretionary annual bonus, stock‑based long‑term incentives, paid time off, and a benefits package that includes company‐sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit:
benefits page .
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Contract Role Details Shift: 4×10. Sunday–Wednesday but may change due to business need (Shifts are Sunday–Wednesday Day (0700‑1800) / Swing (1300‑0000) or Wednesday–Saturday Day (0700‑1800) / Swing (1300‑0000)). Pay: up to $27 per hour.
Position Overview The Quality Control Analytical In‑Process (QCA‑IP) Analyst performs analytical test methods on in‑process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines to support the manufacturing of commercial and clinical therapeutics. The role involves protein determination (A280, Bradford, UV absorbance), enzyme activity, HPLC/UPLC, and method validation.
Key Characteristics and Functional Activities
Perform a wide variety of analytical assays and maintain test sample throughput.
Monitor lab supplies, prepare reagents, and contribute to process and method validation studies.
Support investigations, equipment validation, and brainstorm further development or improvement ideas for procedures.
Work Assignments and Expectations Employees are expected to follow SOPs, make appropriate decisions with minimal intervention, recognize deviations from routine practices, and accurately complete tasks on time to achieve lab goals while limiting GMP/procedural errors. They must interpret results against defined criteria, apply critical thinking, and provide troubleshooting as a trainer. Effective time management, prioritization, proactive communication, and a positive attitude are essential.
Responsibilities
Timely facilitation of incoming sample receipt and accessioning flow, deciphering batch assignments across all assay types.
Execute analytical methods to facilitate in‑process testing under applicable cGMP guidelines.
Evaluate completed assay validity, calculate and summarize results, and assist with trend analysis reports.
Perform housekeeping activities and ensure systems for laboratory maintenance are adequate.
Monitor and control laboratory supply and critical reagent inventories.
Qualify as a trainer for specified methods and provide training to less experienced staff.
Communicate compliance risks and deviations, initiate investigation records within required timeframes.
Provide input or assay support for test method validation, investigations, technical studies, and method transfer protocols.
Attend team huddles and department meetings, generating ideas for laboratory infrastructure improvements and method optimization.
Perform other responsibilities as deemed necessary.
Qualifications
Bachelor of Science degree.
0–3 years of relevant laboratory experience; QC-specific experience preferred.
Experience with quality management systems, current Good Manufacturing Practices, and QC principles.
Demonstrated knowledge of certified functional activities.
Good documentation, written and verbal communication skills.
Ability to perform most tasks with minimal supervision.
Computer literacy with proficiency in Microsoft Word and Excel; experience with PowerPoint preferred.
Quality service attitude, flexibility, and willingness to work additional hours.
Note This description is not intended to be all‑inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Statement An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Salary & Benefits In the U.S., the salary range for this position is $15 to $30 per hour, with the base pay determined by internal equity and may vary depending on candidate's experience, qualifications, and geographic location. The role may also be eligible for a discretionary annual bonus, stock‑based long‑term incentives, paid time off, and a benefits package that includes company‐sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit:
benefits page .
#J-18808-Ljbffr