- Perform the cleaning and sanitization of GMP manufacturing facilities and equipment, ensuring compliance with SOPs and cGMP regulations.
- Assist in media and buffer preparation under supervision, adhering to schedules, and maintaining accurate documentation.
- Assist in tube set preparation under supervision, adhering to specific procedures and documentation practices.
- Replenish cleaning and consumables supplies required for manufacturing operations, setting reorder points, and placing orders as per forecast demand.
- 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.
- Contribute to process improvement initiatives, providing feedback and suggestions to enhance department related processes and improve efficiency.
- Follow safety procedures and maintain a clean workspace.
- High school diploma required.
- Prior experience in a manufacturing or laboratory environment is preferred.
- Exposure to facility or equipment cleaning and sanitization, media and buffer preparation, or equipment building and setup is preferred.
- Experience following SOPs or other protocols/work instructions.
- Basic computer skills and the ability to learn and use manufacturing software.
- Must be self-motivated, a team player, organized and proactive.
- Ability to work hours necessary to support production and/or product transfer activities.
- 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
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GMP Manufacturing Support Technician - Grove City, United States - Forge Biologics
Description
Job Description
Job DescriptionAbout 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 sanitization of GMP equipment and facilities, preparing tubing sets, and contributing to media and buffer formulation. This position offers an opportunity to gain foundational experience in the multifaceted support activities crucial for the production of AAV gene therapy products.
What You'll Do:
What You'll Bring:
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.
