Columbus, OH, 43201, USA
6 days ago
Gene Therapy QC Scientist I
We are currently hiring for a Quality Control Scientist to support the testing and analysis of cGMP produced viral vectors and cells for one of the largest Gene Therapy manufacturing companies in the area! This role will be primarily performing hands on laboratory testing in addition to documentation per necessary regulations. This is a long-term, career opportunity for someone looking to break into the industry! An ideal candidate will have a Bachelors Degree in a scientific field and strong biological laboratory experience from outside of just class (can include industry work, research projects, etc.). Responsibilities + The individual will work primarily in the Quality Department to support the testing and analysis of cGMP produced viral vectors and cells + Works in close collaboration with the QC manager and senior QC staff to cultivate and enact strategic direction to the GMP area + Under the guidance of senior staff, duties will include: performance of QC methods, development of methods, analysis of microbiological environmental monitoring samples, writing/revising SOP’s, equipment maintenance and monitoring, and materials management of QC and Production supplies. + Lab testing will include PCR, qPCR, ddPCR, Dilutions, Gel Electrophoresis, Ph, and more. + Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF. + Ensure all product samples are adequately labelled and all aspects of sample allocation and transition are appropriately documented in the respective format and systems. + Ensure full accountability for product as it is allocated across sample requirements and storage conditions. + Evaluate processes associated with sample management to identify gaps and implement improvements. + Ensure documentation is completed, reviewed, filed and archived according to Standard Operating Procedures (SOPs). + Maintain compliance with applicable regulatory requirements for cellular and gene therapy products. + Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed + Works under close supervision of senior staff and leadership. + Functional working in diverse and collaborative team environment utilizing clear communication to deliver high productivity. + Documentation of all activities performed according to SOPs. Qualifications: + Must have a Bachelors Degree in a scientific field. + Must have biological related laboratory experience outside of just a general laboratory class (such as industry experience, or even research projects from school may suffice). Pay and Benefits The pay range for this position is $24.00 - $24.00 Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Columbus,OH. Application Deadline This position will be accepting applications until Dec 27, 2024. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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