Bioprocess Technician - Clinical Supply Center

Roche; South San Francisco (CA); Vor Ort; USD 61.000 - 128.000; Vollzeit

Zusammenfassung

Roche in South San Francisco, CA seeks a Bioprocess Technician to join the CSC Main Operations team. The role involves end-to-end process execution from Solution Preparation to Downstream, supporting both upstream and downstream operations on a standard day shift with potential for weekend work.

Strong collaboration, problem-solving, and GMP rigor are essential. Ideal candidates have a BA/BS in a life science or engineering field and at least three years of related experience.

Qualifikationen

• Bachelor's degree in life sciences or engineering preferred; 3+ years of relevant work experience.
• Experience in GMP environments and pharmaceutical operations.
• Ability to work in fast-paced, dynamic settings and collaborate across groups.

Aufgaben

• Accountable for ensuring production timelines are met.
• Execute upstream/downstream operations and support solution preparation as needed.
• Perform routine sampling, EMS verification, and in-process documentation.
• Communicate proactively with management, researchers, and peers.
• Operate automation/process systems (e.g., Syncade, DeltaV, MES, LIMS).
• Identify issues, escalate, and propose solutions based on GMP/Lean principles.
• Work with minimal supervision and adapt to agile environments.
• Support a flexible schedule, including day, weekend, and swing shifts.

Kenntnisse

GMP experience

Lean/Agile mindset

Problem solving

Communication

Team collaboration

Ausbildung

Bachelor's degree in life science or engineering

Tools

ASPIRE

SAP

DeltaV

MES

Single LIMS

Jobbeschreibung

The Bioprocess Technician is a member of the Operations, Process Support and Process Engineering (OPP) team for the Clinical Supply Center (CSC) Drug Substance (DS) Manufacturing in South San Francisco (SSF).

The Bioprocess Technician will be 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.

In this role the Bioprocess Technician will be part of the CSC Main Operation team that executes all operation activities on the production schedule. The candidate will establish relationships with customer groups and peers by seeking opportunities for collaboration, proactively communicating and become proficient on the end to end process from Solution Preparation 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.

Monday to Friday day shift

NOTE- Weekend work, off hours and swing shift work may be required

The Opportunity:

• Accountable for ensuring that production timelines 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)

• Execute main operation activities associated with Upstream and Downstream operations (e.g. inoculation, batch and prep, harvest, chromatography, viral filtration). Will also support Solution Prep activities as needed.

• Perform routine EM and WFI sampling and EMS verification.

• Perform accurate real-time documentation on all required worksheets and software.

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

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

• 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.

• Strong behaviors aligned with Pharma Technical (PT) expectations including Lean/Agile, collaboration, speaking up, decision making and continuous improvement

• Ability to work in an agile and ambiguous environment

• Commitment to quality and excellence

• Growth mindset with a passion for taking on challenges in order to deliver business value while developing

• Entrepreneurial spirit within a GMP environment

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.

• Facilitates communication and information transfer between different groups.

Who You Are:

• BA/BS in a life science, engineering or equivalent is preferred with at least three years of relevant work experience

• Ability to work in fast paced dynamic work environment

• Experience using single use technology

• Ability to prioritize project assignments, to meet deadlines, be flexible in workload priorities, and to recognize and accurately report problems

• Proven excellent in customer service and ability to problem-solve and make decisions

• Working conditions include extensive walking/standing, ability to lift, push and pull up to 30 pounds

• Be able to work a flexible schedule (e.g Day, Weekend and Swing Shift Schedule)

Relocation benefits are not available for this position.

The expected salary range for this position based on the primary location of California is $61,300 to $113,900 for MT3 and $68,740 to $127,660 for MT4. 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.