Hands-on experience with various size bioreactors (both single-use bioreactor (SUB) and traditional SS tank) and applying the previously mentioned techniques across those scales is desired. The ...
Hands-on experience with various size bioreactors (both single-use bioreactor (SUB) and traditional SS tank) and applying the previously mentioned techniques across those scales is desired. The ...
Upstream Process Engineer II
Redmond, WA ยท On-site
Solid understanding of upstream processing including hands on experience in single-use bioreactor operations and perfusion technology either at Manufacturing scale or in process development of ...
Upstream Process Engineer II
Redmond, WA ยท On-site
Solid understanding of upstream processing including hands on experience in single-use bioreactor operations and perfusion technology either at Manufacturing scale or in process development of ...
Hands-on experience with perfusion and single use bioreactor systems at various scales from benchtop to pilot/production scale and technologies that enable closed and automated cell therapy ...
Hands-on experience with perfusion and single use bioreactor systems at various scales from benchtop to pilot/production scale and technologies that enable closed and automated cell therapy ...
Upstream Process Engineer II
Redmond, WA ยท On-site
Solid understanding of upstream processing including hands on experience in single-use bioreactor operations and perfusion technology either at Manufacturing scale or in process development of ...
Upstream Process Engineer II
Redmond, WA ยท On-site
Solid understanding of upstream processing including hands on experience in single-use bioreactor operations and perfusion technology either at Manufacturing scale or in process development of ...
Senior Director, Late Stage Cell Therapy Process Development
Cambridge, MA ยท On-site
$250K - $300K/yr
Hands-on experience with perfusion and single use bioreactor systems at various scales from benchtop to pilot/production scale and technologies that enable closed and automated cell therapy ...
Senior Director, Late Stage Cell Therapy Process Development
Cambridge, MA ยท On-site
$250K - $300K/yr
Hands-on experience with perfusion and single use bioreactor systems at various scales from benchtop to pilot/production scale and technologies that enable closed and automated cell therapy ...
Equipment Validation Engineer
Moorpark, CA ยท On-site
$99K - $120K/yr
... single-use bioreactor systems that enable scalable, high-performance processes for life-saving therapies. As a fast-growing biotechnology company, we are committed to delivering cutting-edge ...
Quick apply
Equipment Validation Engineer
Moorpark, CA ยท On-site
$99K - $120K/yr
... single-use bioreactor systems that enable scalable, high-performance processes for life-saving therapies. As a fast-growing biotechnology company, we are committed to delivering cutting-edge ...
Equipment Validation Engineer
Moorpark, CA ยท On-site
$99K - $120K/yr
... single-use bioreactor systems that enable scalable, high-performance processes for life-saving therapies. As a fast-growing biotechnology company, we are committed to delivering cutting-edge ...
Quick apply
Equipment Validation Engineer
Moorpark, CA ยท On-site
$99K - $120K/yr
... single-use bioreactor systems that enable scalable, high-performance processes for life-saving therapies. As a fast-growing biotechnology company, we are committed to delivering cutting-edge ...
Scientist, Viral Vector Process Development, Upstream
Gaithersburg, MD ยท On-site
$92K - $138K/yr
Bioreactor Operations & Scale Translation: Execute unit operations across seed, production, and ... Experience with single use systems, process automation/PAT,and digital lab systems (ELN/LIMS ...
Scientist, Viral Vector Process Development, Upstream
Gaithersburg, MD ยท On-site
$92K - $138K/yr
Bioreactor Operations & Scale Translation: Execute unit operations across seed, production, and ... Experience with single use systems, process automation/PAT,and digital lab systems (ELN/LIMS ...
Manufacturing Engineer III- Viral Vector Clinical Operations
Santa Monica, CA ยท On-site
$81K - $105K/yr
Vial thaw, shake flask, pooling operations within proper aseptic technique in a biosafety cabinet, and single use bioreactor units. * Proficiency and routine maintenance of auxiliary equipment ...
Manufacturing Engineer III- Viral Vector Clinical Operations
Santa Monica, CA ยท On-site
$81K - $105K/yr
Vial thaw, shake flask, pooling operations within proper aseptic technique in a biosafety cabinet, and single use bioreactor units. * Proficiency and routine maintenance of auxiliary equipment ...
Manufacturing Engineer III- Viral Vector Clinical Operations
Santa Monica, CA ยท On-site
$81K - $105K/yr
Vial thaw, shake flask, pooling operations within proper aseptic technique in a biosafety cabinet, and single use bioreactor units. * Proficiency and routine maintenance of auxiliary equipment ...
Manufacturing Engineer III- Viral Vector Clinical Operations
Santa Monica, CA ยท On-site
$81K - $105K/yr
Vial thaw, shake flask, pooling operations within proper aseptic technique in a biosafety cabinet, and single use bioreactor units. * Proficiency and routine maintenance of auxiliary equipment ...
Process Development Associate I/II
Durham, NC ยท On-site
$55K - $75K/yr
... 200 L Xcellerex single-use bioreactors). * Performs calculations for growth data, specific productivity, bioreactor agitation and gassing scale up/scale down. Assist in data analysis using ...
Process Development Associate I/II
Durham, NC ยท On-site
$55K - $75K/yr
... 200 L Xcellerex single-use bioreactors). * Performs calculations for growth data, specific productivity, bioreactor agitation and gassing scale up/scale down. Assist in data analysis using ...
Senior Manufacturing Associate
Oceanside, CA ยท On-site
$92K - $120K/yr
Maintain mammalian cell culture in flasks, CellSTACK chambers and single use bioreactor systems. * Review and sign off batch records for completeness, accuracy, and compliance. * Participate in and ...
Senior Manufacturing Associate
Oceanside, CA ยท On-site
$92K - $120K/yr
Maintain mammalian cell culture in flasks, CellSTACK chambers and single use bioreactor systems. * Review and sign off batch records for completeness, accuracy, and compliance. * Participate in and ...
This position requires technical expertise in bioreactor operations, cell biology and knowledge of ... Experience working with single use manufacturing consumables such as bags, tube sets, columns and ...
This position requires technical expertise in bioreactor operations, cell biology and knowledge of ... Experience working with single use manufacturing consumables such as bags, tube sets, columns and ...
Bioreactor experience is a plus * Experience operating single-use bioprocessing equipment and unit operations such as perfusion, continuous centrifugation, automated magnetic cell separation, buffer ...
Bioreactor experience is a plus * Experience operating single-use bioprocessing equipment and unit operations such as perfusion, continuous centrifugation, automated magnetic cell separation, buffer ...
This position requires technical expertise in bioreactor operations, cell biology and knowledge of ... single use manufacturing consumables such as bags, tube sets, columns and process manifolds.
This position requires technical expertise in bioreactor operations, cell biology and knowledge of ... single use manufacturing consumables such as bags, tube sets, columns and process manifolds.
Continuation Engineer
Minneapolis, MN ยท On-site
C3 also manufactures, distributes and services AcuSyst perfusion bioreactor systems. Our advantage ... and single-use disposables that are manufactured in a QSR, ISO, or similar environment.
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Continuation Engineer
Minneapolis, MN ยท On-site
C3 also manufactures, distributes and services AcuSyst perfusion bioreactor systems. Our advantage ... and single-use disposables that are manufactured in a QSR, ISO, or similar environment.
Continuation Engineer
Minneapolis, MN ยท On-site
C3 also manufactures, distributes and services AcuSyst perfusion bioreactor systems. Our advantage ... and single-use disposables that are manufactured in a QSR, ISO, or similar environment.
Continuation Engineer
Minneapolis, MN ยท On-site
C3 also manufactures, distributes and services AcuSyst perfusion bioreactor systems. Our advantage ... and single-use disposables that are manufactured in a QSR, ISO, or similar environment.
Perform and monitor critical processes (i.e., Single use bioreactor operations, perfusion, chromatography, product filtration, and solution preparation) * Supporting the introduction of new products ...
New
Perform and monitor critical processes (i.e., Single use bioreactor operations, perfusion, chromatography, product filtration, and solution preparation) * Supporting the introduction of new products ...
New
Senior Manufacturing Associate
$92K - $120K/yr
Maintain mammalian cell culture in flasks, CellSTACK chambers and single use bioreactor systems. * Review and sign off batch records for completeness, accuracy, and compliance. * Participate in and ...
Senior Manufacturing Associate
$92K - $120K/yr
Maintain mammalian cell culture in flasks, CellSTACK chambers and single use bioreactor systems. * Review and sign off batch records for completeness, accuracy, and compliance. * Participate in and ...
Manufacturing Associate II Swing Shift- Wed-Sat
Redmond, WA ยท On-site
$28 - $36/hr
Perform and monitor critical processes (i.e., Single use bioreactor operations, perfusion, chromatography, product filtration, and solution preparation) * Supporting the introduction of new products ...
Manufacturing Associate II Swing Shift- Wed-Sat
Redmond, WA ยท On-site
$28 - $36/hr
Perform and monitor critical processes (i.e., Single use bioreactor operations, perfusion, chromatography, product filtration, and solution preparation) * Supporting the introduction of new products ...
Single Use Bioreactor information
What is the difference between Single Use Bioreactor vs Bioprocess Engineer?
| Aspect | Single Use Bioreactor | Bioprocess Engineer |
|---|---|---|
| Credentials | Biotech or chemical engineering degree, relevant certifications | Biotech or chemical engineering degree, process validation certifications |
| Work Environment | Laboratory and manufacturing facilities, cleanroom settings | Research labs, manufacturing plants, process development areas |
| Industry Usage | Biopharmaceutical manufacturing, biotech production | Process development, scale-up, manufacturing oversight |
Single Use Bioreactors are specialized equipment used in biopharmaceutical production, focusing on cultivation of cells in disposable bioreactor systems. Bioprocess Engineers design, optimize, and oversee these processes. While both roles operate within the biotech industry and require similar credentials, the Single Use Bioreactor role is more equipment-focused, whereas the Bioprocess Engineer handles overall process development and validation.

Full-time
Posted 26 days ago
Job description
Work Location - Cranbury NJ
Job Summary
Reporting to the Head of Manufacturing, the Head of Upstream will play a pivotal role in establishing the Manufacturing Department initially during start-up by supporting operational readiness and providing operations input to ensure the facility design meets end-user requirements and latterly, post-start-up, by leading the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs). The Upstream Lead will work closely with the management team and MSAT (Material Science & Technology) teams to ensure the effective and efficient tech transfer of products and processes to the MFG11 Facility
Responsibilities
- Key member of the Manufacturing leadership team for MFG11. Will play an important role in the strategy and business planning processes, ensuring cross-functional collaboration and leadership execution.
- Support the execution of the overall Manufacturing strategy aligned with the facility's strategic business plans.
- Lead a team of Shift Leads, Specialists, and engineers to execute routine manufacturing activities in the commercial scale manufacturing of therapeutic proteins in a mammalian cell culture facility.
- Supervise daily Upstream manufacturing activities and ensure production timelines are met.
- Collaborate with the management team and MSAT groups on technical transfer and process validation
- Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
- Provides working knowledge and technical leadership in cell culture operations.
- Schedule and/or deliver training to manufacturing personnel to ensure staff can perform manufacturing operations safely and compliantly.
- Motivate, retain, develop existing group members and recruit new staff to build a strong Upstream manufacturing team
- Contribute to continual improvement of all manufacturing documentation (SOP MBRs, OJTs) to ensure they are current, accurate, and clear.
- Communicate operational status regularly to senior management, as required, at the appropriate level of detail.
- Assist the Head of Manufacturing in coordinating the work between the Upstream groups and other functional groups to meet the production objectives and timelines.
- Perform all duties by GMP requirements, SOPs, and controlled documents
- Will be flexible to take on additional tasks and responsibilities at the discretion of the MFG Lead
- Will act as a role model for the Manufacturing function and the wider organization in adherence to the WuXi corporate core values and PROUD culture.
Qualifications
- BSc, MSc or PhD in Chemical Engineering, Bioscience, or Biotechnology. Masters level qualification would be advantageous.
- More than 10 years in biopharmaceutical manufacturing with extensive experience in Upstream processing.
- Experience in dealing with FDA, and/or EMA and have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control.
- Experience in CIP, SIP, clean room and water system (Purified Water, pure steam, and WFI).
- Ideally, experienced in establishing a Manufacturing department and building a team in a 'greenfield' context of similar size and scale
- A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant.
- A strong background in cellular metabolism, and various mammalian cell lines, and be scientifically minded. Hands-on experience with various size bioreactors (both single-use bioreactor (SUB) and traditional SS tank) and applying the previously mentioned techniques across those scales is desired. The individual needs to have a good understanding of DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification).
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 based on disability