Appia Bio, Inc.
TechOps Associate Scientist / Scientist I; Analytical Sciences Culver City
Appia Bio, Inc., Los Angeles, California, United States, 90079
Associate Scientist / Scientist I; Analytical Sciences
Culver CityAbout our CompanyAppia Bio is a preclinical stage biotech company founded in 2020 with the mission to bring innovative off-the-shelf cell therapies to cancer patients. Our goal is to discover and develop allogeneic cell therapies across a broad array of cancer indications with a scalability that increases access for patients.REPORTING RELATIONSHIP: Reports to Principal Scientist, Analytical DevelopmentPOSITION SUMMARYAppia’s Analytical Sciences team is seeking a passionate and innovative Associate Scientist / Scientist I. The candidate will be responsible for developing cell-based analytical methods aligned with vector and allogeneic cellular therapy product quality attributes to enable process development, product characterization, stability and release testing of Appia Bio’s novel engineered cell therapy products.RESPONSIBILITIESEmploy quality by design (QbD) and design of experiment (DOE) approaches to quickly identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines.Execute and document analytical method development activities and assay execution for the following techniques (depending on candidate’s expertise) towards enabling process development and product understanding:
cell culture/passagingimmunophenotyping using multi-parametric flow cytometryplate-based immunoassaysdroplet digital PCR
Work with Process Development in executing and documenting analytical methods as part of experimental study plans supporting the process development of Appia’s novel cell therapy platforms.Author, review, and edit accurate technical documents related to method development & qualification, equipment usage, and training.Assist in technology transfer of analytical methods to contract manufacturing and development organizations and/or external business partners.Participate in group and department meetings by presenting scientific data and communicating expertise in areas of responsibility.Maintain, calibrate, and operate analytical equipment and instrumentation that is used routinely in the execution of assays.Ensure that departmental area is maintained per 5S guidelines.Other duties as assigned.EXPERIENCE AND QUALIFICATIONSMS in Immunology, Cell Biology, or related discipline with 6-8+ years of industry experience or an advanced degree (Ph.D.) with 0+ years of experience.Demonstrate expertise with developing and/or executing any or all of the following analytical methods:
plate-based immunoassays (e.g. ELISA, MSD, Luminex, AlpaLISA)multi-parametric flow cytometrymammalian cell-based potency assays (e.g co-culture, cytotoxicity, proliferation)droplet digital PCR using the QX200 (Bio-Rad)
Experience with Good Documentation Practices and analytical method development for execution in a GMP environment.Excellent skills in Microsoft Office and data analysis software (e.g. Prism, JMP, FlowJo, CytExpert, SoftMax Pro).Ability to think critically and demonstrate troubleshooting and problem-solving skills.Excellent interpersonal, verbal, and written communication skills.Experience and aptitude in working in a multidisciplinary, fast-paced laboratory environment with moderate supervision.Preferred Qualifications
Demonstrate knowledge of process development of cellular therapy products and analytical method development for GMP.Experience in development and qualification of immunoassays, multi-parameter flow cytometry, and potency methods for release in a QC/regulated environment.Knowledge of QbD approaches to analytical method development including gap and risk assessments, DOE and statistical analysis.Appia Bio requires COVID-19 vaccination for all employees. As required by applicable law, we will consider reasonable accommodations.Culver City Pay Range: $99,189 - $130,295 USDCompetitive Compensation Packages | Cost Sharing for Health Insurance Premiums | Flexible Work Environment | Untracked PTO | 401(k) Retirement Savings Plan Match | Life Insurance & Disability | Awesome Culture | Challenging & Fulfilling Work | Equity Options | and more.Appia Bio is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
#J-18808-Ljbffr
Culver CityAbout our CompanyAppia Bio is a preclinical stage biotech company founded in 2020 with the mission to bring innovative off-the-shelf cell therapies to cancer patients. Our goal is to discover and develop allogeneic cell therapies across a broad array of cancer indications with a scalability that increases access for patients.REPORTING RELATIONSHIP: Reports to Principal Scientist, Analytical DevelopmentPOSITION SUMMARYAppia’s Analytical Sciences team is seeking a passionate and innovative Associate Scientist / Scientist I. The candidate will be responsible for developing cell-based analytical methods aligned with vector and allogeneic cellular therapy product quality attributes to enable process development, product characterization, stability and release testing of Appia Bio’s novel engineered cell therapy products.RESPONSIBILITIESEmploy quality by design (QbD) and design of experiment (DOE) approaches to quickly identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines.Execute and document analytical method development activities and assay execution for the following techniques (depending on candidate’s expertise) towards enabling process development and product understanding:
cell culture/passagingimmunophenotyping using multi-parametric flow cytometryplate-based immunoassaysdroplet digital PCR
Work with Process Development in executing and documenting analytical methods as part of experimental study plans supporting the process development of Appia’s novel cell therapy platforms.Author, review, and edit accurate technical documents related to method development & qualification, equipment usage, and training.Assist in technology transfer of analytical methods to contract manufacturing and development organizations and/or external business partners.Participate in group and department meetings by presenting scientific data and communicating expertise in areas of responsibility.Maintain, calibrate, and operate analytical equipment and instrumentation that is used routinely in the execution of assays.Ensure that departmental area is maintained per 5S guidelines.Other duties as assigned.EXPERIENCE AND QUALIFICATIONSMS in Immunology, Cell Biology, or related discipline with 6-8+ years of industry experience or an advanced degree (Ph.D.) with 0+ years of experience.Demonstrate expertise with developing and/or executing any or all of the following analytical methods:
plate-based immunoassays (e.g. ELISA, MSD, Luminex, AlpaLISA)multi-parametric flow cytometrymammalian cell-based potency assays (e.g co-culture, cytotoxicity, proliferation)droplet digital PCR using the QX200 (Bio-Rad)
Experience with Good Documentation Practices and analytical method development for execution in a GMP environment.Excellent skills in Microsoft Office and data analysis software (e.g. Prism, JMP, FlowJo, CytExpert, SoftMax Pro).Ability to think critically and demonstrate troubleshooting and problem-solving skills.Excellent interpersonal, verbal, and written communication skills.Experience and aptitude in working in a multidisciplinary, fast-paced laboratory environment with moderate supervision.Preferred Qualifications
Demonstrate knowledge of process development of cellular therapy products and analytical method development for GMP.Experience in development and qualification of immunoassays, multi-parameter flow cytometry, and potency methods for release in a QC/regulated environment.Knowledge of QbD approaches to analytical method development including gap and risk assessments, DOE and statistical analysis.Appia Bio requires COVID-19 vaccination for all employees. As required by applicable law, we will consider reasonable accommodations.Culver City Pay Range: $99,189 - $130,295 USDCompetitive Compensation Packages | Cost Sharing for Health Insurance Premiums | Flexible Work Environment | Untracked PTO | 401(k) Retirement Savings Plan Match | Life Insurance & Disability | Awesome Culture | Challenging & Fulfilling Work | Equity Options | and more.Appia Bio is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
#J-18808-Ljbffr