Head of Analytical

Philadelphia, PA

Apply Apply with LinkedIn

Type: Direct-Hire

Experience: 0

Category: Scientific & Clinical

Brand: Joule

Job ID: 300243

Date Posted: 09/15/2023

Shortcut: http://jobs.systemone.com/TafTjh

  Title: Head of Analytical - Cell and Gene Therapy
Location: Philadelphia, PA
Type: Direct Hire
Start date: ASAP

Our client is a CDMO whose focus is in the Cell and Gene Therapy field. They are looking for a Director of QC and Analytical Services to develop laboratory procedures and build out Laboratory Services. Ideal candidates will have a working knowledge of bioassay analytical development, QC, and assay technical transfers within the cell and gene therapy space, as well as experience creating laboratory SOPs, GMPs and other requirements, processes and procedures.  


  • Supporting a build-out of a facility and team of scientists conducting analytical development, quality control, and assay technical transfer (molecular team, biochemical team, bioassay team, physical/chemical team, and quality control (QC) team
  • Oversee analytical development and testing activities as well as ensure appropriate training and documentation for bioassays 
  • Authoring and reviewing development and technical reports, SOPs and test records, study reports, qualification reports, and relevant sections of regulatory submissions and participating in the establishment of electronic information systems
  • Overseeing QC functions, including QC testing, analytical testing, and stability programs
  • Oversee the development, conduct, and qualification as necessary of assays to evaluate viral vector drug substance and drug product concentration purity, identity, and infectivity
  • Oversee the conduct of analytical studies such as biodistribution and shedding and testing for stability studies. Analytical testing may be conducted as research testing or as GLP/GMP testing with Quality Assurance oversight
  • Build and manage strong relationships with vendors and external suppliers in support of technical and clinical operations.

  • Bachelor’s/Master’s degree with 10-15 years of experience or Ph.D. with 8-10 years
  • Working knowledge of methods and assays such as ddPCR, qPCR, ELISA, TCID50, and RCAAV to oversee development and testing activities as well as ensure appropriate training and documentation (technical reports, test records)
  • Strong Technical writing skills
  • Must have knowledge of molecular and/or biochemical and/or cell-based assays for the characterization of biological products
  • Must have a thorough understanding of GxP and of CMC regulatory guidance for the manufacturing and testing of gene therapy products
Our client provides a comprehensive benefits package; competitive salaries plus bonus, medical, dental, vision, PTO 

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

  • Analytical Lab Tech

    Philadelphia, PA

    Job Title: Analytical Laboratory Technician Location: Philadelphia PA Hours/Schedule: Monday- Friday, 8:00am-5:00pm Type: Direct Overview Our client a company in the field of development and manufacturing of viral vectors, is looking to add an Analytic...

    Date Posted: 09/19/2023 Recommended

  • Research Assistant III / Team lead

    Rockville, Maryland

    Job Title: Research Assistant III/Team Lead Location: Rockville, MD Hours/Schedule: M-F, 8:30am – 5 PM Type: Temporary to Hire Overview: Our client is a nonprofit organization dedicated to advancing military medicine. They serve military, medical, acad...

    Date Posted: 09/15/2023 Recommended

  • Senior Research Associate

    Bridgewater, New Jersey

    Title: Senior Research Associate Location: Bridgewater, NJ Schedule: Monday-Friday, 8am-5pm with flexible start / end times Start: ASAP Responsibilities: The candidate will support the research team to investigate therapeutics for the treatment of infl...

    Date Posted: 09/15/2023 Recommended

  • Scientist

    Tarrytown, NY

    Job Title: Scientist Location: Tarrytown, NY Hours/Schedule: M-F Full Time Compensation: $55 - $60 per hour Type: Contract Overview Our client is a reputable pharmaceutical company whose focus is on the research and development of life-transforming med...

    Date Posted: 09/27/2023 Recommended

  • Scientist

    Bethesda, Maryland

    Title: Scientist _ Immunology Location: Bethesda, MD Schedule: M-F 8am-5pm Type: 12-month contract Renewable Nationally recognized Research Center is looking for a Biologist in Bethesda, MD! Responsibilities: Plan and execute research experiments in th...

    Date Posted: 10/01/2023 Recommended

  • Senior Manager of Manufacturing-Cell & Gene Therapy

    Philadelphia, PA

    Title: Senior Manager of Manufacturing-Cell & Gene Therapy Location: Philadelphia, PA Schedule: Monday – Friday (8am-5pm) Type: Direct Hire Start date: Immediate Overview: Our client is a CDMO start-up company whose focus is in the Cell and Gene Therap...

    Date Posted: 09/21/2023 Recommended

  • Biologist

    Bethesda, Maryland

    Title: Biologist - Cell Culture Location: Bethesda, MD Schedule: M-F 8am-5pm Type: 12-month contract Renewable Nationally recognized Research Center is looking for a Biologist in Bethesda, MD! Responsibilities: Prepare cell cultures for virus inoculati...

    Date Posted: 10/01/2023 Recommended

  • Research Associate-Scientific

    Seattle, WA

    Job Title: Research Associate-Scientific Location: Seattle, WA Hours/Schedule: Second shift will range from 12-8pm to 2-10pm but will mostly be 12-8pm. The weekly schedule would be Monday to Friday with approximately one Sunday per month. Compensation:...

    Date Posted: 09/19/2023 Recommended

  • Research Associate III

    Bothell, WA

    Title: Research Associate III Location: Onsite Start date: ASAP Pay Rate Range: 38-43 The Company is seeking a Research Associate to participate in the development of drug programs. This role is within the target discovery team and entails cell and mol...

    Date Posted: 09/28/2023 Recommended

  • Assistant QC Scientist

    New Brunswick, New Jersey

    Job Title: Assistant QC Scientist Location: New Brunswick/Summit, NJ Type: Contract Overview A Leading Global pharmaceutical company, with a location in NJ is looking to bring on an Assistant QC Scientist to join their team. Candidates with a backgroun...

    Date Posted: 09/14/2023 Recommended

  • Senior Scientist

    Groton, Connecticut

    Job Title: Senior Scientist Location: Groton, CT Type: Contract Join one of the worlds premiere Biopharmaceutical company which prioritizes the health and well-being of people and the planet to deliver breakthroughs around the world in a responsible wa...

    Date Posted: 09/27/2023 Recommended

  • Associate Scientist

    Tarrytown, NY

    Title: Associate Scientist (Neuroscience) Location: Tarrytown, NY Schedule: M-F Full Time Type: Contract Responsibilities Dedicated to collaborative research to develop new delivery technologies and therapeutic strategies for nervous system diseases. I...

    Date Posted: 09/11/2023 Recommended

  • Research Associate III, Antibody Discovery

    Bothell, WA

    Title: Research Associate III, Antibody Discovery Location: Bothell, WA Start date: ASAP Pay Rate Range: $38 - 43/hr We are seeking a collaborative and independent Research Associate III (RA III) to participate in development of antibody-based oncology...

    Date Posted: 09/22/2023 Recommended

  • Senior Associate Scientist

    Brisbane, CA

    Join the leading team working with the power of science to address some of the most challenging diseases of our time. Focusing on these unmet needs during a remarkable time, with unprecedented scientific breakthroughs are advancing the treatment of dis...

    Date Posted: 10/02/2023 Recommended

  • Training & Development Specialist

    Summit, NJ

    Job Title: Training & Development Specialist Location: Summit, NJ Hours/Schedule: Evening Shift (2nd shift): Need to be flexible for alternate hours and weekends as well. Shift may be 3PM-11PM or 5PM-1AM, possibility of morning, OT/weekends. Type: Cont...

    Date Posted: 09/27/2023 Recommended