Manufacturing Biotechnologist

Notes:

• This role is a Night Shift.
• This means they will alternate weeks:
• One week: Monday, Tuesday, Friday, Saturday, Sunday
• Next week: Wednesday, Thursday
• Night shift timing: 18:30 – 06:30
• This role will work on the floor primarily in the Buffer Prep area in Mid-Scale.
• Workers will be working on Concentrates and with P11.

Job Description

The Manufacturing Associate Level I is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. The role involves executing process recipes, following standard operating procedures (SOPs), monitoring equipment and processes, and performing basic laboratory tasks such as pH, conductivity, and sampling. The associate is also responsible for routine sanitization of equipment and maintaining facility standards while developing a foundational understanding of cGMP compliance under close supervision.

Key Responsibilities:

• Set up, operate equipment, and monitor production processes including CIP (Clean-in-Place) and SIP (Steam-in-Place) operations; document activities per GMP and GDP requirements
• Attain qualification for all assigned tasks and maintain an individual training plan
• Perform basic laboratory tasks such as monitoring pH, conductivity, and testing product samples
• Handle material movements including transfer of raw materials and chemicals across production areas
• Maintain facility and equipment through routine cleaning and sanitization; support 6S initiatives
• Perform administrative duties such as shift handovers, attending meetings, email communication, and project participation
• Perform additional duties as assigned

Work Location

• Production Suite

Key Stakeholders

• Manufacturing Team
• Manufacturing Supervisor
• Manufacturing Manager

Supervision

• Close Supervision – Work is performed according to specified procedures with detailed instructions and frequent review

2. Qualifications

Education

• Required: High School Diploma or equivalent
• Preferred: Associate’s or Bachelor’s degree in a science-related discipline

Experience

• Entry Level: 0–4 years of manufacturing experience

Skills & Competencies

• Strong logical thinking and decision-making ability
• Critical thinking skills
• Effective written and verbal communication

Core Competencies

Agility

• Demonstrates willingness to learn and adapt
• Treats errors as learning opportunities
• Supports process improvement initiatives

Business Acumen

• Understands business impact of actions
• Contributes ideas for improvement
• Makes timely and informed decisions

Collaboration

• Works effectively within a team
• Shares knowledge and information
• Respects diverse perspectives

Customer Focus

• Understands customer requirements
• Responds to feedback constructively
• Works to improve customer satisfaction

Driving Results

• Delivers goals while maintaining quality
• Demonstrates persistence and accountability
• Plans and prioritizes work effectively

Leadership

• Takes responsibility for safety and actions
• Seeks continuous improvement
• Contributes positively to the team environment

Responsibilities

People

• No direct reports

Budget

• Ensure accurate timesheet completion
• Support cost-saving initiatives
• Handle materials and equipment responsibly

Quality

• Adhere to cGMP standards at all times
• Report deviations, defects, and compliance issues promptly

Safety

• Follow all safety procedures and training
• Promote a safe work environment
• Report hazards, incidents, or injuries immediately

3. Essential Job Functions

Work Schedule

• Rotating manufacturing schedule (day or night shifts)

Travel

• Less than 10%

Work Environment

• Production floor environment
• Requires PPE including gowning, safety shoes, and safety glasses

Physical Demands

• Frequent standing, bending, kneeling, and reaching
• Occasional walking, sitting, and fine motor tasks
• Lifting requirements: up to 25–50 lbs

Mental Requirements

• Ability to understand process flow and identify influencing factors
• Follow SOPs and policies accurately
• Perform basic manufacturing tasks independently
• Identify and communicate non-routine events
• Operate automated equipment and tools effectively

Safety & Quality Responsibility

• Maintain compliance with all safety policies
• Ensure adherence to cGMP standards
• Take ownership of quality and compliance in all tasks