QC Control Associate (Flow Cytometry) (Contractor)

Genentech; Oregon, Hillsboro (IL, OR); On-site; USD 60,000 - 80,000; Full time

Job summary

Join a forward-thinking company as a Quality Control Associate, where you'll play a vital role in ensuring the quality and consistency of groundbreaking cell and gene therapies. This position offers the chance to work with innovative technologies and methodologies in a collaborative environment. You'll be part of a dedicated team focused on analytical development, ensuring compliance with industry regulations while supporting the clinical development of life-changing therapies. If you're passionate about quality control and analytical testing, this opportunity could be your next big step.

Qualifications

• 2 years experience or a graduate degree with 1 year experience.
• Knowledge of cGMPs and analytical testing procedures.

Responsibilities

• Conduct analytical testing for cell and gene therapies.
• Ensure compliance with cGMP regulations and quality standards.

Skills

Flow Cytometry

Analytical Testing

cGMP Regulations

Data Analysis

Education

Bachelor's Degree

Graduate Degree

Job description

The Position

This position is part of Genentech's Pharma Technical - Hillsboro Innovative Therapies (HIT) team working on various individualized and non-individualized cell and gene therapies based in Hillsboro, Oregon.

As a member of the HIT Analytical Development and Testing (ADT) team, you will be implementing various analytical methods to enable the manufacturing of DNA/RNA and cell therapeutics. You'll be part of the consolidated analytical development team responsible for supporting the development of new modalities in the newly created Pharma Technical Cell and Gene Therapy (PTC) organization. PTC focuses on the development of cell and gene therapies for the treatment or cure of various diseases.

Pay Rate - $33-$37/hour (depends on experience)
Shift: Day Shift: 8:00 am to 4:30 pm

Contract duration: 12 months (possible extensions up to 36 months)

The Opportunity

TheQuality Control Associatewill be responsible for the establishment of processes for, and execution of, analytical testing to enable the manufacturing of cell and gene therapies. In this role, you will perform Quality Control operations according to established processes to ensure production consistency and product quality as well as support analytical development for the clinical development of cell and gene therapies. Additionally, you will:

• Ensure compliance with cGMP regulations
• Conduct analytical testing for process development, cleaning validation, investigations, extended characterization, in-process control, and product release
• Perform and support analytical activities, including assay transfer and validation, to meet project timelines
• Conduct technical reviews of data, comparing with established acceptance criteria
• Write or reviewqualification/maintenancelifecycle documents, method implementation documents, and procedures with senior team member input
• Participate in project teams, process improvement initiatives, internal and external audits, and regulatory inspections
• Identify, communicate, and address potential quality or regulatory issues impacting product quality or compliance

Who you Are

• You have a bachelor's degree and two years of experience OR a graduate degree plus one year of experience
• You have experience performing flow cytometry assays and analysis
• You have demonstrated knowledge of cGMPs or equivalent regulations
• You have demonstrated knowledge and application of scientific theories, principles, and techniques used in analytical or biological test procedures
• You have experience working in an office and laboratory environment

Preferred:

• Degree in Biology, Biochemistry, Molecular Biology
• Experience in pharmaceutical or biopharmaceutical industry

Work Environment/Physical Demands/ Safety Considerations:

• Prolonged periods of standing/sitting at lab bench top
• Frequent lifting (up to 25 lbs), bending, reaching, twisting
• Use of stepladders and pushcarts
• Must be able to pass a visual screening assessment

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.