Aseptic Processing Technician contract-to-hire
Aseptic Processing Technician contract-to-hire
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Salary Not Disclosed
1 Vacancy
Job Description
Overview
Iovance Biotherapeutics is seeking an Aseptic Processing Technician (contracttohire) to join the team at 700 Spring Garden St Philadelphia PA. Colocated at the American Red Cross Building this Iovance facility produces a critical raw material used in the companys TIL process. Processing is performed in an ISO 7 cleanroom within an ISO 5 biological safety cabinet.
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.
This is a 1st shift position working a 4 day week Tuesday Friday 7am 5pm
Essential Functions and Responsibilities
- Complete training sessions and ensure training documentation is maintained.
- Proficiently carry out procedures to achieve a consistent errorfree 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.
- 02 years of experience in biopharmaceuticalbased 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 fastpaced teamoriented 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 midrange 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 halfface 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 problemsolving analysis and discretion; ability to handle workrelated 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.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal opportunity employer our employees and applicants will be considered without regard to an individuals race color religion sex pregnancy national origin age physical and mental disability marital status sexual orientation gender identity gender expression genetic information military and veteran status and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities please contact .
By voluntarily providing information and clicking Submit Application you explicitly consent to the collection and use of your personal information for the purposes described above and in ourCandidate Privacy Notice.
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Required Experience:
IC
Employment Type
Contract
