Bioprocess Technician - Clinical Supply Center

The Clinical Supply Center Bioprocess Technician is an integral member of the Clinical Supply Center (CSC) team in South San Francisco (SSF). The SSF CSC is a state-of-the-art large molecule drug substance facility which supports GMP production for phase 1, 2 and early phase 3 clinical trials. The CSC employs a ballroom design, utilizing single-use technology, new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility. We are looking for individuals to support this facility who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical Behaviors, and have an agile mindset. Ability to collaborate is crucial as success will be measured as a member of a team, not just as an individual. Ideal candidates would have experience in a broad range of functional roles in support of biopharmaceutical production.

In this role the qualified individual will be part of the CSC Main Operation team as the point of contact for all operation activities that will execute the production schedule. The candidate will establish relationships with customer groups and peers by seeking opportunities for collaboration, proactively communicating and becoming proficient on the end to end process from Upstream to Downstream. Candidates are initially expected to have a fundamental understanding of the cell culture and purification process and will develop additional expertise over time through a combination of role assignments and coaching.

This position requires an on-site presence in order to perform the essential operation activities and operational responsibilities of the role.

The Opportunity:

• Execute main operation activities associated with Downstream operations (e.g. harvest, chromatography, viral filtration, UFDF, and bulk filtration).

• Accountable for ensuring that production timeline are met

• Perform a variety of tasks to ensure that all the materials, recipes and consumables are available when needed. (e.g. ASPIRE/ SAP, 5S)

• Experience in single used technology and single used consumables

• Initiate and support assessments for deviations as it arises

• Perform accurate real-time documentation on all required work.

• Operation and understanding of automation/process systems. (e.g. Syncade, DeltaV, MES, Single LIMS)

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

• Outline, develop, publish, and train on SOPs.

• Able to perform routine cell culture monitoring and sampling during routine operation.

• Use problem-solving skills to report and help address anomalies or deviations found on the floor.

• Proactive communication with management, researchers and peers to provide feedback on operations.

• Contribute to the planning, scheduling and execution of process/workflow improvements.

• Exercise good independent judgment and provide potential solutions to problems based on experience with GLP, cGMP, QMS, Lean Manufacturing principles.

• Ability to work with minimal supervision.

• Be a driving force on the team to meet production deadlines while maintaining a safe, efficient, and positive lab environment.

• Perform other related duties as assigned including supporting operations in Solution Prep.

This position requires strong adherence to compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents. As with any position in a manufacturing environment, the job requires an ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule.

NOTE- weekendwork and or shift work may be required

Operational Responsibilities:

• To ensure operation activities are executed on time and according to procedures.

• Drives continuous improvement in our process to gain efficiency.

• Collaborates proactively with peers and support groups (e.g. Automation, Quality, Vendor, and Facility) to ensure robust communication.

• Understands Drug Substance process parameters and is able to recognize when there is an issue.

• Escalate Basecamp recipe issues and ensure they are being addressed in a timely manner.

• Creates training materials to improve increased learning and the onboarding process.

Who You Are:

• 1-3 years of experience OR a Bachelor Degree

• Ability to execute Process Equipment projects in a GMP environment.

• Understand current GMP requirements and regulations

• Strong strategic thinker

• Possess excellent interpersonal and communication skills

• Strong problem solving and critical thinking skills

PREFERRED: Downstream experience

Relocation benefits are not available for this position.

The expected salary range for this position based on the primary location of California is $61,600 to $114,40 for Associate Technician level (MT4) and $76,510 to $142,090 for Technician level (MT5). 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.

Benefits

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.