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Cell Therapy Manufacturing Specialist II
2 months ago
Location: United States, Portsmouth (New Hampshire)
Company Overview:
Lonza is a leading global entity in the life sciences sector, operating across multiple continents. Our success is driven by our talented workforce collaborating to generate innovative solutions that empower businesses to enhance human health. We believe in allowing our employees to take charge of their careers, fostering an environment where every idea contributes to making a positive impact on the world.
Shift Schedule:
The shift pattern is organized from 7pm to 7am on a rotating weekly basis:
- Week 1: MON/TUE/FRI/SAT/SUN
- Week 2: WED/THUR
- Weekend work includes shift differentials.
- Each week incorporates 8 hours of overtime.
- New hires will undergo a 2-week training period on the day shift, Monday to Friday.
Role Overview:
The Cell Therapy Manufacturing Specialist II will play a crucial role in ensuring a safe and controlled work environment across various operational areas. This position requires proficiency in specific domains (e.g., Cell Growth, Drug Product Filling) and collaboration within a team during manufacturing processes (e.g., harvest, fill/finish, visual inspection).
Key Responsibilities:
- Engage with customer Subject Matter Experts (SMEs) to integrate and sustain client processes within the production facility.
- Organize and deliver effective training for manufacturing personnel regarding new equipment or systems related to Cell Therapy.
- Work alongside the Cell Therapy Manufacturing Leadership team to implement process enhancements for new customer operations.
- Assist in identifying necessary equipment and materials for manufacturing processes.
Operational Readiness:
Support the establishment and execution of Operational Readiness Activities for Cell Therapy projects, including:
- Development of manufacturing procedures in collaboration with Quality Assurance to align with existing and new operations.
- Contribute to building and training the manufacturing team through involvement in the recruitment and onboarding processes.
- Facilitate the delivery of clinical and commercial materials as needed.
Technical Transfer Support:
Assist in defining and executing Technical Transfer activities for Cell Therapy projects, including:
- Providing operational insights into material requirements and process execution.
- Supporting the execution of manufacturing activities related to Technical Transfer.
- Ensuring timely achievement of Technical Transfer milestones.
- Authoring and reviewing documentation for accuracy and completeness.
- Contributing to suite readiness tasks in compliance with Environmental Health and Safety (EHS) standards.
Collaboration:
As a project contributor, work with the Cell Therapy Manufacturing Leadership Team to ensure:
- Accurate tracking of project metrics.
- Progression of purchase requisitions and orders.
- Effective communication with both internal and external stakeholders.
Qualifications:
- Minimum of a High School Diploma or equivalent; AS/BS degree preferred.
- Preferred fields of study include science-related disciplines, particularly Genetics.
- Prior experience in a cleanroom or sterile environment is advantageous.
- Familiarity with Aseptic Techniques and gowning procedures is preferred.
- Experience in a manufacturing environment, particularly in a cGMP setting, is ideal.
- Ability to adhere to documentation protocols in a regulated industry.
- Strong critical thinking and decision-making skills.
- Excellent written and verbal communication abilities.
- Demonstrated adaptability to changing business priorities and a willingness to seek feedback for performance improvement.
At Lonza, we are committed to making a positive impact on millions of lives through our products and services. We uphold the highest ethical standards in achieving our business goals, valuing both our people and the environment.
Lonza is an equal opportunity employer, and we welcome applications from all qualified individuals without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability status, protected veteran status, or any other characteristic protected by law.
