Aseptic Processing Technician
2 weeks ago
TWO SHIFT OPTIONS:
1ST SHIFT: TUES-FRIDAY 7AM-5PM
2ND SHIFT: 5PM-3AM
Overview
As an Aseptic Processing Technician, you will focus on the documentation for our processes. The ideal candidate will have a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to ensure the manufacturing process is completed.
Essential Functions and Responsibilities
- Complete training sessions and ensure training documentation is maintained.
- Proficiently carry out procedures to achieve a consistent, error-free execution of daily job assignments
- Work as part of a team to produce each lot accurately and fully complete batch records, forms, and documentation.
- At all times, understand and comply with quality standards and safety guidelines.
- Perform materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
- Identify errors and report them promptly to lab management. Participate in root cause analysis and implement corrective actions.
- Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
Travel - Up to 5% of travel
Required Education, Skills, and Knowledge
- Minimum AS degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
- 0-2 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
- Able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
- Able to accurately perform basic math, including fractions, decimals, and percentages.
- Able to work effectively with team members and show initiative to assist others on the team.
- Able to work successfully in a fast-paced, team-oriented environment.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
Preferred Qualifications:
- Demonstrated technical knowledge of aseptic processing in cleanroom environments.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
For the Visual Inspection Program, the technician must be able to pass a Vision Exam that includes the following:
- Must not be color blind.
- Must have 20/20 near vision in both eyes (can be corrected)
Physical Demands and Activities Required:
- Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish
- Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
- Must meet requirements for and be able to wear a half-face respirator.
- Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
- Ability to crouch, bend, twist, reach, and perform activities with repetitive motions
- Ability to lift 45 lbs.
Mental:
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment:
This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
-
Aseptic Processing Professional
5 days ago
Philadelphia, Pennsylvania, United States Proclinical Staffing Full timeAs an Aseptic Processing Professional, you will play a critical role in executing GMP cell therapy manufacturing processes in our Philadelphia, PA facility.The ideal candidate will possess a strong background in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.Key...
-
Cell Therapy Process Technician
3 days ago
Philadelphia, Pennsylvania, United States Proclinical Staffing Full timeWe are looking for a Cell Therapy Process Technician to execute GMP cell therapy manufacturing processes in our Philadelphia, PA facility.The successful candidate will have a strong understanding of mammalian cell culture under aseptic conditions and the ability to complete and maintain training documentation.Key Responsibilities:Perform routine assignments...
-
Philadelphia, Pennsylvania, United States R&D Partners Full timeAbout the RoleWe are seeking a seasoned Senior Aseptic Manufacturing Operations Manager to join our team at R&D Partners. This individual will play a pivotal role in overseeing and executing training programs for the aseptic manufacturing team.The successful candidate will have a strong background in cell culture, aseptic technique, and processing, as well...
-
Aseptic Manufacturing Training Supervisor
1 week ago
Philadelphia, United States R&D Partners Full timeJob DescriptionJob DescriptionThe Training Specialist Supervisor will oversee Training Specialists within the Manufacturing Training Department. This position will play a pivotal role in overseeing and executing training programs for the aseptic manufacturing team. This individual will ensure that all manufacturing personnel are...
-
Philadelphia, Pennsylvania, United States R&D Partners Full timeRole OverviewWe are seeking a highly skilled Biopharmaceutical Aseptic Manufacturing Specialist to join our team at R&D Partners.This role is focused on supporting the autologous cell therapy manufacturing program, requiring expertise in cell culture, aseptic gowning, and ISO class 5 cleanroom operations.Key ResponsibilitiesDevelop a Subject Matter Expert...
-
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeJob OverviewIovance Biotherapeutics Inc. is seeking an experienced Aseptic Manufacturing Leader to provide guidance and leadership to the manufacturing teams. This role requires a strong understanding of theories, techniques, and principles to support manufacturing processes.Salary and BenefitsThe estimated annual salary for this position is $65,000-$85,000,...
-
Cell Manufacturing Technician
3 weeks ago
Philadelphia, United States Proclinical Staffing Full timeCell Manufacturing Technician - Contract - Philadelphia, PAProclinical is seeking a dedicated Cell Manufacturing Technician to join a dynamic team. Primary Responsibilities:The successful candidate will be required to focus on executing cell therapy manufacturing processes, maintaining quality standards, and supporting operational functions. This position...
-
Sterile Processing Specialist
4 weeks ago
Philadelphia, Pennsylvania, United States Temple University Full timeAbout the RoleWe are seeking a highly skilled Sterile Processing Specialist to join our team at Temple Health. In this role, you will be responsible for cleaning, inspecting, and assembling equipment and supplies under the direction of the central sterile manager. You will provide units/departments with clean, sterile supplies while employing aseptic...
-
Sterile Processing Technician
1 month ago
Philadelphia, United States Jefferson Health Full timeJob Summary Schedule: 11 am - 7:30 pm The Sterile Processing Technician is responsible for daily operations to support the operating rooms and various other units as needed. They are responsible for ensuring surgical supplies, instruments, scopes and equipment are properly inventoried, decontaminated, assembled, inspected, packaged, sterilized, stored,...
-
Certified Sterile Processing Technician
1 month ago
Philadelphia, United States JobRialto Full timeJob Description:The Sterile Processing Technician ensures the effective decontamination, inspection, assembly, packaging, sterilization, storage, inventory, and tracking of all reusable surgical supplies, instruments, and equipment. This role adheres to established hospital and departmental protocols to maintain a safe and sterile environment for patient...
-
Upstream Process Development Associate
4 weeks ago
Philadelphia, United States Actalent Full timeJob DescriptionJob DescriptionJob Title: Upstream Process Development AssociateJob DescriptionThe Upstream Process Development Associate is involved in the execution of recombinant adeno-associated viral vector (rAAV) production processes. This role includes conducting experiments, aggregating and reviewing experimental data, verifying data in technical...
-
Upstream Process Development Associate
4 weeks ago
Philadelphia, United States Actalent Full timeJob DescriptionJob DescriptionJob Title: Upstream Process Development AssociateJob DescriptionThe Upstream Process Development Associate is involved in the execution of recombinant adeno-associated viral vector (rAAV) production processes. This role includes conducting experiments, aggregating and reviewing experimental data, verifying data in technical...
-
Certified Sterile Processing Technician
1 month ago
Philadelphia, United States JobRialto Full timeJob Description: The Sterile Processing Technician ensures the effective decontamination, inspection, assembly, packaging, sterilization, storage, inventory, and tracking of all reusable surgical supplies, instruments, and equipment. This role adheres to established hospital and departmental protocols to maintain a safe and sterile environment for patient...
-
Philadelphia, Pennsylvania, United States Aequor Full timeAquor Job OpportunityWe are seeking a skilled Sterile Processing Technician to join our team at Aequor in Philadelphia. This role is ideal for those with a passion for ensuring the highest standards of patient care.About the Role:This position involves working in our sterile processing department, where you will be responsible for preparing and sterilizing...
-
Master Machinist Educator
1 day ago
Philadelphia, Pennsylvania, United States Philadelphia Technician Training Institute Full timeJob DescriptionPhiladelphia Technician Training Institute (PTTI) is seeking an experienced professional to fill the role of Master Machinist Educator at our Berean campus. This position requires a candidate who can ensure program graduates are professionally prepared as manufacturing technicians, capable of making significant contributions in manufacturing...
-
GI TECHNICIAN
3 days ago
Philadelphia, United States Temple University Health System Full timeAssists with endoscopic procedures, sets up the room with equipment needed for each specific procedure and is responsible for scope reprocessing and preparation of accessory equipment for sterilization. Performs duties adhering to standards of aseptic techniques and in accordance with the Gastroenterology Unit and Temple University Hospital policies and...
-
Manufacturing Instructor
1 month ago
Philadelphia, United States Philadelphia Technician Training Institute Full timeJob DescriptionJob DescriptionPhiladelphia Technician Training Institute (PTTII) seeks an individual to serve as a Manufacturing Instructor at our Berean campus. Successful applicants will be tasked with must ensuring program graduates are professionally prepared as manufacturing technicians. PTTI's graduates must be capable of making significant...
-
Manufacturing Process Manager
24 hours ago
Philadelphia, Pennsylvania, United States Planet Pharma Full timeUnlock a rewarding career as a Manufacturing Process Manager at Planet Pharma!About the RoleWe are seeking an experienced professional to lead our manufacturing operations, ensuring seamless execution and continuous improvement. As a key member of our team, you will be responsible for overseeing daily production processes, developing and implementing process...
-
MSAT Specialist
5 days ago
Philadelphia, Pennsylvania, United States Planet Pharma Full timeJob Description:Planet Pharma is seeking a highly skilled MSAT Specialist to join our team. This role requires a strong understanding of manufacturing operations and data analysis, as well as excellent technical writing skills.Responsibilities:Serve as a subject matter expert in manufacturing processes, providing technical guidance and support during...
-
Manufacturing Process Specialist
6 days ago
Philadelphia, Pennsylvania, United States Planet Pharma Full timeAbout the RoleWe are seeking a highly skilled Manufacturing Process Specialist to join our team at Planet Pharma. In this role, you will play a critical part in ensuring the successful development and execution of manufacturing processes for cell therapy products.Key ResponsibilitiesServe as a subject matter expert in manufacturing processes, providing...