(CW) QC Analyst Contract

BioSpace; Novato (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

BioMarin is seeking a Quality Control Analytical In-Process (QCA-IP) Analyst to perform analytical tests on in-process intermediates and drug products under cGMP. The role supports manufacturing for clinical and commercial therapeutics, including protein determination, enzyme activity, UV, HPLC/UPLC, and method validation.

The ideal candidate has a BS degree and up to 3 years of relevant lab experience, with strong documentation and communication skills, and familiarity with BINOCS or SAP

Qualifications

• Bachelor of Science degree.
• 0-3 years of relevant laboratory experience; QC experience preferred.
• Experience with quality management systems, cGMP, and QC principles.
• Demonstrated working knowledge of certified functional activities.
• Strong writing and verbal communication skills is essential.
• Ability to perform most tasks with minimal supervision.
• Proficiency with Microsoft Word and Excel.
• BINOCS or SAP familiarity is preferred.

Responsibilities

• Timely facilitation of incoming sample receipt and accessioning.
• Execute analytical methods for in-process testing under cGMP guidelines.
• Evaluate assay validity, summarize results, and assist trend analysis.
• Maintain lab housekeeping and readiness for inspections.
• Monitor inventory of laboratory supplies and reagents.
• Provide training for specified methods to staff.
• Escalate compliance risks and document investigations promptly.
• Support method validation, investigations, and transfer protocols.
• Participate in team meetings and propose infrastructure improvements.
• Identify opportunities to improve operational efficiency.
• Perform other duties as needed.

Skills

Attention to detail

Written communication

Verbal communication

Minimal supervision

Education

Bachelor of Science

Tools

BINOCS

SAP

Microsoft Word

Microsoft Excel

Job description

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world‑class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting‑edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

THIS A CONTRACT ROLE

Shift: Wednesday - Saturday (Onsite 4 days), swing shift (1pm-11:30 pm)

PURPOSE

The Quality Control Analytical In-Process (QCA-IP) Analyst is responsible for performing analytical test methods on in-process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics. This role will involve knowledge that includes but is not limited to the following analyses and concepts: Protein determination by A280, Bradford, UV Absorbance, Enzyme activity, HPLC/UPLC, and method validation.

CHARACTERISTICS

Functional activities may include: performing a wide variety of analytical assays, maintaining test sample throughput, monitoring lab supplies, preparing reagents, contributing to process and method validation studies, supporting investigations and equipment validation, and brainstorming further development or improvement ideas for procedures. Work assignments will vary by degree of complexity. Employee is expected to follow SOPs, make appropriate decisions in daily activities with minimal needs for intervention, and be able to recognise deviations from routine practices. Incumbent must accurately complete tasks on time to achieve lab goals, meanwhile limiting GMP / procedural errors, and be capable of accepting and incorporating feedback. Must also demonstrate the ability to both manage time and prioritise routine work effectively. Employee must be able to interpret results against defined criteria, begin to apply critical thinking to routine work. He/she should demonstrate an ability to evaluate results against trend reports, serve some degree of troubleshooting and capacity as trainer, and embrace an active role in following up on atypical results or issues. Communication of relevant information must be made to appropriate audiences, and attendance of necessary team meetings with some participation in discussions is essential. Employee should also be actively engaged in his/her role, exhibit frequent volunteerism as the work schedule flow permits and maintain a positive attitude.

Responsibilities

• Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with best practices.
• Execute analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers.
• Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.
• Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
• Assist with monitoring and the control of laboratory supply and critical reagent inventories.
• Qualify as trainer for specified methods, provide training to less experienced staff.
• Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes.
• Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
• Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
• Identify areas to improve operational excellence by reducing non-value-added activities and increasing process efficiency.
• Perform other responsibilities as deemed necessary.

Qualifications

• Bachelor of Science degree.
• 0-3 years of relevant laboratory experience; QC specific experience is preferred.
• Experience with quality management systems, current Good Manufacturing Practices, and QC principles.
• Demonstrated working knowledge with respect to certified functional activities.
• Good documentation, written and verbal communication skills are essential.
• Must possess the ability to perform most tasks with minimal supervision.
• Computer literacy is required, with proficiency in Microsoft Word and Excel, and
• Familiarity with BINOCS or similar scheduling systems is preferred.
• Familiarity with SAP or similar enterprise systems is preferred.
• Must have a quality service attitude and focus, exhibit flexibility and willingness to work

Experience In Microsoft PowerPoint Preferred.

• Familiarity with BINOCS or similar scheduling systems is preferred.
• Familiarity with SAP or similar enterprise systems is preferred.
• Must have a quality service attitude and focus, exhibit flexibility and willingness to work

Additional Hours To Meet Production Or Laboratory Process Requirements.

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 Employer/Veterans/Disabled

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.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.