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Analyst I, Quality Control (Analytical)
Forge Biologics Columbus, OH
$75k-96k (estimate)
Full Time | Durable Manufacturing 1 Month Ago
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Forge Biologics is Hiring an Analyst I, Quality Control (Analytical) Near Columbus, OH

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

Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality. Forge has a 200,000 ft2 facility in Columbus, Ohio, “The Hearth,” to serve as their headquarters. The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. 

About The Role

The Analyst I, Quality Control (Analytical) will execute routine quality control tests, maintaining meticulous records, and ensuring the accuracy of data for AAV gene therapy products. This position is responsible for working with senior team members, adhering to established protocols and contributing to the efficiency of quality assessments. This entry-level position offers an excellent opportunity to gain hands-on experience in the field of gene therapy.

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.
  • Execute routine analytical tests and quality control assays, such as qPCR, ELISA, SDS-PAGE, Western blot, and HPLC, to assess the purity, potency, and safety of AAV vector products.
  • Utilize molecular biology techniques including DNA and RNA extraction, gel electrophoresis, and PCR to support product characterization.
  • Maintain detailed records of experimental procedures, outcomes, and observations following Good Documentation Practices (GDP).
  • Adhere to established Standard Operating Procedures (SOPs), cGMP guidelines, and regulatory requirements during all tasks.
  • Collaborate with cross-functional teams to address quality-related issues and ensure timely product release.
  • Assist in equipment maintenance, calibration, and qualification activities to ensure reliable test results.
  • Assist in sample coordination for contract testing, ensuring proper paperwork is completed and shipping procedures are followed.

What You'll Bring

  • Bachelor's degree in a relevant scientific field (e.g., biology, biochemistry, molecular biology).
  • Experience with molecular biology, biochemistry, or cell biology techniques and analytical methods (e.g., qPCR, Elisa, Western Blot).
  • Familiarity with basic data analysis tools and software (e.g., Excel).
  • Strong attention to detail and the ability to follow standard operating procedures (SOPs).
  • Demonstrated teamwork and communication skills within a laboratory setting.

Work Environment and Physical Demands 

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.

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
  • Flexible PTO (plus 14 paid company holidays)
  • Annual bonus for all full-time employees
  • 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

Job Summary

JOB TYPE

Full Time

INDUSTRY

Durable Manufacturing

SALARY

$75k-96k (estimate)

POST DATE

03/05/2024

EXPIRATION DATE

05/04/2024

WEBSITE

forgebiologics.com

HEADQUARTERS

GROVE CITY, OH

SIZE

50 - 100

FOUNDED

2020

TYPE

Private

CEO

TIMOTHY MILLER

REVENUE

<$5M

INDUSTRY

Durable Manufacturing

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About Forge Biologics

Forge is an Ohio-based CDMO firm that provides gene therapy manufacturing, preclinical validation and related solutions for the pharmaceutical industry.

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