59 applicants

Company

Original Job Post

Cellares · 3 days ago

Senior Process Engineer

South San Francisco, CA

Full-time

Onsite

Senior Level

$90K/yr - $210K/yr

4+ years exp

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BiotechnologyLife Science

H1B Sponsorship

Growth Opportunities

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Responsibilities

Lead the transfer of cell therapy analytical methods to QC from internal Cellares AD or directly from customers

Author assay qualification protocols and training QC team for protocol execution

Evaluate analytical methods for feasibility, method improvement, remediation, and/or troubleshooting

Support analytical method transfer and trending with statistical analysis

Responsible for the authoring, review, approval, and oversight of analytical method procedures, method - reports, method validation, training and tech transfer protocols and reports for internal and external analytical methods

Participate and contribute towards regulatory submissions

Lead continuous cGMP analytical improvement projects. This includes, but may not be limited to, constant state of validation, improvement of methods and sustaining compliance with global requirements

Work as the MSAT Analytical Specialist representative on client projects

Prepare and present data associated with QC processes to internal and external clients

Define and provide user requirements for QC equipment for the testing of manufactured cell therapies

Work with the software team on integration solutions for the QC process and data management, including MES, QMS, and LIMS

Provide technical leadership to QC and other departments associated with GMP QC operations

Accountable to comply with GxP regulations, guidelines, procedures, and practices governing analytical methods for release and stability testing.

Collaborate with internal and external groups cross-functionally as a subject matter expert to ensure compliance, OOS/OOE/OOT investigations, deviations, change controls and CAPAs

Collaborate and work effectively with other MSAT groups, as well as other departments such as QC, QA, AD colleagues, to investigate and troubleshoot the manufacturing process

Provide input when troubleshooting processes on the QC floor

Additional duties as assigned

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Biologics/gene therapyAnalytical method testingCDMO experienceQC principlesCell therapy characterizationFlow cytometryELISACell-based assaysQPCRDdPCRPotency methodsAnalytical transferQualificationValidationStatistical methodsGMP documentationCGMP regulationsQbDICH Validation of analytical proceduresFDA regulationsAuthoring technical documentsProtocolsSOP’sDeviationsCAPAsRegulatory filingsRapidly evolving organizationTechnology advancementSupporting projectsPrioritizing projects

Required

Bachelor's degree in science, engineering, or related field required

4+ years experience in biologics/gene therapy with a primary focus on analytical method testing and/or transfer for cell therapy products. CDMO experience is a plus

Knowledge of QC principles, concepts, industry practices, and standards

Knowledge of and experience in relevant cell therapy characterization analytical methods including flow cytometry, ELISA, cell based assays, qPCR and ddPCR

Exposure to one or more advanced potency methods, such as cytotoxicity or cytokine characterization

Understanding of analytical transfer, qualification, and validation, and statistical methods

Experience writing, reviewing and approving GMP documentation

Understanding of cGMP and regulations/guidance, can interpret guidance documents and make technical recommendations. (QbD, ICH Validation of analytical procedures, FDA regulations)

Excellent oral and written communication skills to effectively communicate with internal/external stakeholders, and to author technical documents (protocols, reports, SOP’s, investigations, deviations, CAPAs, regulatory filings)

Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level

Self-motivated and passionate about advancing the field of cell therapy

Excellent planning, organization, technical writing, and time-management skills including the ability to support, problem-solve, and prioritize multiple projects and deadlines

Self-awareness, integrity, authenticity, and a growth mindset

Benefits

Medical, Dental, and Vision Plans

401(k) Matching

Free EV Charging

Onsite lunches

Stock options

Company

Cellares

Cellares is a life sciences technology company that develops the Cell Shuttle to automate cell therapy manufacturing.

Founded in 2019

South San Francisco, California, USA

51-200 employees

https://www.cellares.com

H1B Sponsorship

Cellares has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (2)

2022 (1)

2020 (1)