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Senior Aseptic Manufacturing Technician

2 months ago

Philadelphia, United States R&D Partners Full time $70,000 - $72,000
Job DescriptionJob Description

Overview

The hiring company is an immuno-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). The company's lead candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma. The company has Phase 2 clinical trials in progress for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors. The company currently is developing its clinical and commercial manufacturing capacity to support development and launch of these assets. 

As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is strongly desired.

Shifts: A or B (Shift Differential - 10%)

Shift A-Rotation

  • Week 1
    • Sunday to Tuesday: 6:00PM – 6:30AM
  • Week 2
    • Sunday to Wednesday : 6:00PM – 5:30AOR

 

Shift B-Rotation

  • Week 1
    • Wednesday to Saturday: 6:00PM – 5:30AM
  • Week 2
    • Thursday to Saturday: 6:00PM – 6:30AM

Essential Functions and Responsibilities

 

  • Develop a Subject Matter Expert (SME)-level understanding of and be able to skillfully execute as well as troubleshoot Iovance’s GMP cell therapy manufacturing process(es).
  • Complete training sessions and ensure training documentation is maintained.
  • Understand and comply with quality standards and requirements as documented.
  • Provide operational support functions including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
  • Perform document review, including executed Batch Records and Logbooks.
  • Aseptic Manufacturing Technicians are required to work their assigned schedule. The first few months of onboarding training for this position will occur during regular work week hours (1st shift M-F); however, once the technician is trained, they will be assigned to a shift that may include weekends, evenings, and holidays, as needed (i.e. Shifts may be Sunday to Wednesday, Wednesday to Saturday, Thursday to Sunday, etc). May be required to work overtime.
  • Support documentation needs, which may include drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
  • Execute documentation Change Controls of SOPs, Batch records, etc. as needed
  • Supports technical transfer and additional research level testing activities, as needed
  • May support training sessions as a qualified trainer, ensuring training documentation is maintained.
  • Assists with identification of training needs, establishing a feedback loop to ensure continuous improvement
  • May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
  • Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
  • Attend or hold the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.
  • Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required. 
  • Other duties as assigned.

 

Basic Qualifications

 

  • Bachelor's degree or some post-secondary education or equivalent experience. 
  • Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
  • Ability to mentor and provide best practices to new technicians. 
  • Must be able deal with ambiguity – ready to change gears and plans quickly, able to manage constant change.
  • Must be able to read, write and understand English especially for Good Documentation Practices, and be proficient in Microsoft (Excel, Word, Outlook).
  • Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.

Preferred Qualifications

  • Minimum 3 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
  • Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors. May be given a visual exam for visual acuity and color perception.
  • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
  • Proactive, results oriented, self-starter with experience in a complex manufacturing environment.
  • May require up to 5% travel, based on business need.

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:

  • Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, 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%) of a 10-hr day which may include climbing ladders or steps.
  • Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
  • Must be able to lift and carry objects weighing 45 pounds.

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 deadline

Work environment:

  • This position will work in both an office and a manufacturing lab setting.
  • When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
  • Able to work in cleanroom with biohazards, human blood components, and chemicals.
  • Potential exposure to noise and equipment hazards and strong odors. 
Company DescriptionR&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.

The cornerstone of our success: a knowledgeable and experienced recruiting team.

Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.Company DescriptionR&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.\r
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The cornerstone of our success: a knowledgeable and experienced recruiting team.\r
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Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.