Cell Therapy Manufacturing Specialist
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Job Location:
Monthly Salary:
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
The Cell Therapy Manufacturing Specialist is responsible for executing critical manufacturing operations to support the daily production of sterile clinicalgrade cell therapy products. This role operates predominantly within a cleanroom environment under current Good Manufacturing Practices (cGMP) and requires strong aseptic technique attention to detail and commitment to quality.
Key Responsibilities
Aseptic Processing & Cell Culture Operations
- Perform advanced aseptic processing activities including media exchanges vessel passaging harvest and cryopreservation of mammalian cells according to the production schedule.
- Complete and maintain qualifications in aseptic gowning aseptic process execution and cleaning/disinfection.
- Prepare media buffers and reagents as needed to support manufacturing activities.
- Operate maintain and perform basic troubleshooting on production equipment.
- Conduct equipment cleaning disinfection and preventative maintenance tasks in accordance with SOPs.
Documentation Compliance & Quality
- Execute review and contribute to the revision and authorship of SOPs and Master Batch Records (MBRs) under cGMP guidelines.
- Open investigate and close quality records including deviations CAPAs and change controls.
- Initiate and support simple change controls; complete associated tasks in a timely manner.
- Ensure accuracy and compliance of all documentation in accordance with data integrity standards and company policies.
- Achieve PowerUser proficiency in supporting electronic systems (e.g. MasterControl).
Operational Support & Collaboration
- Perform inventory management activities for consumables media cryovials and other materials.
- Assist with material procurement receipt and traceability.
- Train colleagues on foundational process steps equipment operation and support tasks.
- Maintain a safe and compliant working environment ensuring adherence to all SOPs and industry best practices.
- Participate in continuous improvement initiatives and process optimization projects.
- Effectively manage time and multitask to meet production and documentation deadlines.
Qualifications :
Education
- Bachelors degree in a scientific discipline or equivalent direct industry experience.
Experience & Skills
- 2 years of industry experience in mammalian cell culture within a GMP-regulated biopharmaceutical cell therapy or biotechnology manufacturing environment.
- Demonstrated proficiency in aseptic technique and common laboratory skills (pipetting cell handling media preparation) gained through real-world manufacturing or industrial lab experience.
- Strong understanding of mammalian cell biology and its application to cell therapy production environments.
- Comfort working fully gowned in a cleanroom environment with direct experience in classified cleanroom operations.
- Familiarity with 21 CFR Part 11 GxP expectations and industry regulatory standards for manufacturing.
- Excellent verbal and written communication skills.
- Strong interpersonal skills; able to work effectively in a team-oriented production-focused setting.
- Willingness to work evenings weekends and holidays as manufacturing demands require.
Additional Information :
What to Expect in the Hiring Process:
- 10-15 Minute Phone Interview with Region Recruiter
- 45-60 Minute Virtual Interview with Manager and/or Group Leader
Additional Details:
This is a full-time onsite position based on a first-shift schedule (Monday through Friday 8:00am to 5:00pm) with overtime required as needed. Candidates located within a commutable distance to Exton PA are strongly encouraged to apply.
Excellent full-time benefits include:
- comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Ready to take the next step in your career
Apply today and join a team thats making a difference in science every day.
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
