Technician I, GMP Manufacturing Support

2 weeks ago

Inver Grove Heights, Minnesota, United States Forge Biologics Full time
Job Description Job Description

About Forge:

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping 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. 

About The Team:

The GMP Manufacturing Support Technician performs a wide range of functions crucial to AAV gene therapy production. This position is responsible for cleaning and sanitizing GMP equipment and facilities, stocking supplies, and assisting with tubing set preparation. This is a great opportunity to gain hands-on experience in a regulated manufacturing setting and contribute to the production of life-changing gene therapy products.

What You'll Do:

  • Clean and sanitize GMP manufacturing areas and equipment following standard operating procedures (SOPs) and current Good Manufacturing Practices (cGMP) regulations.
  • Assist in tube set preparation under supervision, adhering to specific procedures and documentation practices.
  • Monitor and restock cleaning supplies and consumables, maintaining inventory levels and placing orders as needed.
  • Maintain real-time and accurate documentation; perform the manufacturing review of logbooks, MPR's, and associated documents.
  • Assist in troubleshooting and resolving minor equipment or process-related issues under the guidance of senior team members.
  • Collaborate with cross-functional teams, including GMP Manufacturing, Quality Assurance, Quality Control, and Product Development, to support efficient manufacturing operations.
  • Assist in equipment setup, inventory management, and material requests for cleaning and manufacturing activities.
  • Adhere to strict GMP gowning procedures, including the use of sterile coveralls, boots, hair net, face covering, goggles, and gloves to prevent contamination and ensure compliance with regulatory standards for cleanroom environments.
  • Participate in process improvement initiatives by identifying opportunities to enhance efficiency and compliance.

What You'll Bring:

  • High school diploma required.
  • Experience with cleaning and sanitization, equipment setup, or media preparation is preferred.
  • Ability to follow written instructions, such as SOPs or work instructions.
  • Basic computer skills and the willingness to learn new systems.
  • Must be self-motivated, a team player, organized and proactive.
  • Comfortable performing repetitive tasks and standing for extended periods.
  • Ability to properly wear and maintain sterile coveralls, boots, hair net, face covering, goggles, and gloves in accordance with GMP gowning protocols.
  • Experience in a GMP, manufacturing, laboratory, or cleanroom setting is a plus but not required.
  • Willingness to work hours necessary to support production and/or product transfer activities.

Physical Requirements:

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
  • Competitive Paid Time Off plan
  • 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)
  • Onsite fitness facility
  • Professional & Personal development resources

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