Manufacturing Biotechnologist 1

Key Accountabilities: Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment.

Job Title: Manufacturing Biotechnologist 1
Job Location: Portsmouth, NH
Job Duration: 6 months on W2
Shift: 1st week (Mon, Tues, Fri, Sat, Sun), 2nd week (Wed, Thur) from 6:00 AM - 6:00 PM

Job Description:

• The Manufacturing Associate Level I is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.

Key Accountabilities:

• Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate.
• Attain qualification for all assigned tasks and maintain individual training plan.
• Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc.
• Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.
• Maintain facility and equipment through routine cleaning and sanitization, support 6S programs.
• Administrative tasks attending shift exchange, meetings, sending/receiving emails, participating in projects.
• Perform other duties as assigned.

Qualifications:
Degree Required: High School Diploma
Degree (preferred): AS/BS
Years of Experience: 0-4 Years

Competencies & Behaviors :
Agility:

• Demonstrates an ability and desire to learn from experience
• Treats errors as a learning opportunity
• Is willing to take on new challenges
• Takes steps to adapt thinking and behavior to support change
• Supports a culture of process improvement and problem solving
• Demonstrates an openness to trying new approaches

Business Acumen:

• Seeks to understand the corporate strategy and how his/her business area contributes to the company s success
• Understands the impact of his/her own actions on his/her business area
• Expresses ideas that will improve his/her business area
• Uses knowledge of his/her business area to make accurate and timely decisions

Collaboration:

• Works as an active member of his/her team
• Generously shares information and knowledge with others on team
• Demonstrates an openness to different perspectives by balancing listening and speaking
• Treats all co-workers and customers professionally and with respect

Customer Focus:

• Understands what internal and/or external customers need from him/her to deliver in his/her respective role
• Demonstrates an openness to receiving customer feedback
• Takes action to enhance customer satisfaction within the scope of his/her role

Driving Results:

• Consistently delivers goals while monitoring KPIs with supervisor
• Demonstrates persistence and motivation to overcome obstacles and challenges
• Ensures quality standards are maintained while delivering results
• Plans, prioritizes, and organizes work to deliver on time

Leadership:

• Takes responsibility for his/her safety and that of others
• Takes responsibility for personal choices and behaviors
• Seeks feedback and reflects on his/her development needs in order to continuously improve
• Contributes to a positive work environment
• Acts as a reliable and dependable member of the team

Responsibilities:
Budget:

• Accurate and timely completion of timesheets. Contribute ideas for cost savings where applicable, handle equipment and materials properly to mitigate potential damage / cost.

Quality:

• Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

Safety:

• Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Employee owns their own safety and the safety of others.

Skills:

• Proven logic and decision making abilities, critical thinking skills
• Strong written and verbal communication skills are required