Scientist I, Quality Control

1 month ago

Columbus, Ohio, United States Forge Biologics Full time

About Forge

Our mission at Forge Biologics, is to enable access to life changing gene therapies and help bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.

About The Team

The Quality Control team is a dedicated group responsible for ensuring the safety and efficacy of our advanced gene therapies through rigorous analytical testing. Committed to adherence to regulatory standards, this team performs comprehensive testing on AAV gene therapy products, evaluating vector potency, identity, purity, and stability. With a focus on data integrity and continuous improvement, our QC team plays a crucial role in delivering high-quality products that positively impact patients' lives.

About The Role

The Scientist I, Quality Control (Analytical) will play an active effort in method development and validation. This position will take ownership of complex testing procedures, collaborating on strategic quality initiatives, and providing technical guidance to junior staff. This role provides an opportunity for career growth as you gain experience in the evolving field of gene therapy. This role provides an opportunity to play a significant impact in the success of client gene therapy programs.

What You'll Do

  • Perform in process, release, and stability testing for our most advanced AAV-based (viral vector) therapeutic candidates generated from PD, research, and GMP laboratories.
  • Lead and perform advanced analytical testing quality control assays, including qPCR, ELISA, SDS-PAGE, Western blot, and HPLC, to assess the quality, potency, and safety of AAV vector products.
  • Supports internal process transfer activities and serves as Subject Matter Expert (SME) to troubleshoot processes/assay. May also represent QC as a SME during audits and inspections.
  • Maintain detailed records of experimental procedures, outcomes, and observations following Good Documentation Practices (GDP).
  • Contribute to authoring and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, and justification of specifications.
  • Conducts thorough investigations to determine root cause of OOS investigations and other non-conforming results and implements appropriate corrective and preventative actions in a timely manner.
  • Schedule equipment maintenance, calibration, and qualification activities.
  • Lead sample coordination for contract testing, ensuring proper paperwork is completed and shipping procedures are followed.
  • Drive the development, optimization, and validation of novel analytical methods to enhance quality control processes.
  • Provide technical guidance and mentorship to junior team members, promoting their personal growth and skill development.
  • Compile data with minimal oversight, generating reports, and archiving assay data; responsible for performing the analysis and interpretation of assay results.
  • Draft and revise process documents, assay methods, and sampling plans.

What You'll Bring

  • Bachelor's Degree in Molecular Biology, Biotechnology, Biochemistry, or related field.
  • Experience in mass spectrometry analysis in biological molecules.
  • Advanced knowledge of HPLC, LC-MS and/or LC-MS/MS, as well as any of the following: cell-based assays, PCR, ELISA, SDS-PAGE, CGE, or molecular biology techniques.
  • Experience with the analytical methods used for gene therapy in-process testing, release testing and characterization, with an emphasis on LC-MS, LC-MS/MS and HPLC.
  • Proven ability to execute, troubleshoot, and optimize analytical assays.

Work Environment and Physical Demands

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Life at Forge

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.

  • HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.
  • OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.
  • PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.
  • ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals.

We've Got You Covered

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.

  • Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
  • Unlimited PTO (plus 14 paid company holidays)
  • Annual bonus for all full-time employees
  • Equity-incentive plan
  • 401(K) company match
  • Fully-stocked kitchen with free food/drinks
  • 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care
  • Employee Assistance Program
  • Wellness benefits (financial planning services, mental health counseling, employer paid disability)
  • Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches

  • Quality Control Scientist I

    2 weeks ago

    Columbus, Ohio, United States Forge Biologics Full time

    Position OverviewAbout Forge BiologicsForge Biologics is at the forefront of making transformative gene therapies accessible to patients in need. We work closely with pioneers in the gene therapy sector to expedite the development and production of innovative medical solutions. Our commitment to patients drives us to establish new collaborations and...

  • Scientist I, Quality Assurance and Control

    2 weeks ago

    Columbus, Ohio, United States Forge Biologics Full time

    Job OverviewAbout Forge BiologicsForge Biologics is committed to enhancing access to transformative gene therapies, transitioning innovative concepts into reality. We partner with pioneers in the gene therapy sector to expedite the development and production of groundbreaking medicines. Our focus on patient needs drives us to establish new collaborations and...

  • Quality Control Scientist II

    4 weeks ago

    Columbus, Ohio, United States Actalent Full time

    Job Title: Quality Control Scientist II Job Description 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...

  • Analytical Scientist I, Quality Assurance

    2 weeks ago

    Columbus, Ohio, United States Forge Biologics Full time

    Job OverviewAbout Forge BiologicsForge Biologics is committed to facilitating access to transformative gene therapies, turning innovative concepts into reality. We partner with leaders in the gene therapy sector to expedite the development and production of groundbreaking medicines. Our patient-centric philosophy drives us to establish new collaborations and...

  • Laboratory Scientist I

    2 weeks ago

    Columbus, Ohio, United States Actalent Full time

    Position Title: R&D Scientist IJob Overview:The R&D Scientist I plays a crucial role in the analytical support of pharmaceutical product development. This position involves conducting comprehensive chemical and physical analyses to ensure the manufacturability of a multisource pharmaceutical product. The scientist will provide essential analytical backing...

  • Analyst I, Quality Control

    2 months ago

    Columbus, Ohio, United States Forge Biologics Full time

    About Forge Our mission at Forge Biologics, is to enable access to life changing gene therapies and help bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table,...

  • Medical Lab Scientist

    2 days ago

    Columbus, Ohio, United States Travel Nurses, Inc. Full time

    Job Title: Medical Lab Scientist - Travel NurseWe are seeking a highly skilled Medical Lab Scientist to join our team as a travel nurse. As a Medical Lab Scientist, you will be responsible for performing laboratory tests and analyzing results to aid in the diagnosis and treatment of patients.Job Summary:Perform laboratory tests and analyze results to aid in...

  • Medical Lab Scientist

    1 day ago

    Columbus, Ohio, United States Travel Nurses, Inc. Full time

    Job Title: Medical Lab Scientist - Travel NurseWe are seeking a highly skilled Medical Lab Scientist to join our team as a travel nurse. As a Medical Lab Scientist, you will be responsible for performing various laboratory tests and procedures to aid in the diagnosis and treatment of patients.Job Summary:Perform laboratory tests and procedures to aid in the...

  • Medical Lab Scientist

    2 days ago

    Columbus, Ohio, United States Travel Nurses, Inc. Full time

    Job Title: Medical Lab Scientist - Travel NurseWe are seeking a highly skilled Medical Lab Scientist to join our team as a travel nurse. As a Medical Lab Scientist, you will be responsible for performing various laboratory tests and procedures to aid in the diagnosis and treatment of patients.Job Summary:Perform laboratory tests and procedures to aid in the...

  • Junior Research Scientist

    1 week ago

    Columbus, Ohio, United States Actalent Full time

    Position Title: R&D Scientist IJob Overview:The R&D Scientist I is responsible for performing chemical and physical evaluations to aid in the formulation of a manufacturable multisource pharmaceutical product. This role includes providing analytical assistance for the release of registration materials necessary for regulatory submissions.Key...

  • Quality Control Analyst

    2 weeks ago

    Columbus, Ohio, United States Keurig Dr Pepper Full time

    Quality Technician I As a Quality Technician, you will be responsible for conducting various tests on samples to ensure they meet established specifications and are suitable for production and quality assurance. You will meticulously record and review results, issuing notifications for any samples that do not meet specifications. In cases of significant...

  • Materials Scientist I

    2 days ago

    Columbus, Ohio, United States Battelle Memorial Institute Full time

    About the RoleBattelle Memorial Institute is seeking a highly skilled Materials Scientist to join our Advanced Materials and Energetics Group. As a key member of our team, you will be responsible for conducting laboratory experimentation, data compilation and analysis, and literature searches under the guidance of a senior scientist.Key...

  • Materials Scientist I

    5 days ago

    Columbus, Ohio, United States Battelle Memorial Institute Full time

    About the RoleBattelle Memorial Institute is seeking a highly skilled Materials Scientist/Engineer to join our Advanced Materials and Energetics Group. As a key member of our team, you will be responsible for conducting laboratory experimentation, data compilation and analysis, and literature searches under the guidance of a senior scientist.Key...

  • Quality Control Supervisor

    1 week ago

    Columbus, Ohio, United States Jobot Full time

    Position Overview:This role is hosted by Jobot. We are seeking a dedicated Quality Assurance Manager to enhance our dynamic team.About Us:We pride ourselves on fostering a positive workplace culture that values collaboration and excellence.Compensation and Benefits:- Competitive salary range: $75,000 - $95,000 annually- Comprehensive health benefits-...

  • Lead Scientist, Manufacturing Science

    2 weeks ago

    Columbus, Ohio, United States Forge Biologics Full time

    Job OverviewAbout Forge BiologicsAt Forge Biologics, our mission is to facilitate access to transformative gene therapies, turning innovative ideas into reality. We collaborate with pioneers in the gene therapy sector, including scientists, healthcare professionals, biotech and pharmaceutical companies, and patient advocacy groups. Our expertise in gene...

  • Quality Control Engineer

    2 weeks ago

    Columbus, Ohio, United States NDX Human Capital Solutions Full time

    Objective:The role is designed to deliver technical Quality Assurance expertise to the Quality, Engineering, and Manufacturing sectors within an automotive production environment. This position encompasses the management of the Quality Laboratory by formulating procedures, as well as setting up and calibrating measurement instruments. Furthermore, it...

  • Quality Control Specialist

    1 week ago

    Columbus, Ohio, United States AstrixTechnology LLC Full time

    Job OverviewAstrix Technology LLC is a prominent player in the manufacturing sector, known for its exceptional range of dips and sauces that are staples in households across the nation. The company is committed to being a premier employer, ensuring a rewarding experience for its workforce. With a focus on product innovation and production excellence, the...

  • Lead Bioanalytical Scientist

    1 week ago

    Columbus, Ohio, United States B2S Life Sciences LLC Full time

    Position OverviewThe Lead Bioanalytical Scientist plays a crucial role within the Assay Development division, focusing on the formulation and execution of assays that enhance the company's proficiency in specialized critical reagents. This enables clients to make informed, data-driven choices for superior analytical results in the realm of biotherapeutic...

  • Packaging Quality Control Specialist

    2 weeks ago

    Columbus, Ohio, United States Amerisource Health Services LLC Full time

    Join Our Team at Amerisource Health Services LLCAt Amerisource Health Services LLC, our team members are integral to our mission of fostering healthier futures. Every individual plays a crucial role in our commitment to enhancing the well-being of both people and animals.Your Role:As a Packaging Quality Control Specialist, you will be working the 2nd Shift,...

  • Lead Scientist, Manufacturing Science

    2 weeks ago

    Columbus, Ohio, United States Forge Biologics Full time

    Job OverviewAbout Forge BiologicsAt Forge Biologics, our commitment is to facilitate access to transformative gene therapies, turning innovative concepts into reality. We collaborate with pioneers in the gene therapy sector, including researchers, healthcare professionals, biotech and pharmaceutical companies, and patient advocacy groups. Our expertise in...