Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Senior Accountant, reporting to the Senior Director, Finance Plant Controller, is responsible for the maintenance, execution of day-to-day general accounting activities, and oversight of Iovance manufacturing site’s (iCTC) monthly, quarterly and annual financial reporting and close process, including analysis and reconciliation of certain General Ledger accounts; these accounts will include Accrued Expenses and Capital Assets, as well as possibly supporting activities in certain Inventory accounts. These roles and responsibilities include frequent engagement with other Business Partners, external vendors and parties to understand the business and operations. The Senior Accountant will also be responsible for SOX controls execution and documentation, performing various financial analysis, assist with the external audit, special projects and process improvement initiatives, and prepare and review certain schedules and information.

Specific Responsibilities

• Ensure that iCTC GL transactions are accounted for in accordance with U.S. GAAP
• Prepare and book journal entries for month-end close, including sub-ledger/ schedule to ledger reconciliations and analysis of reconciling items
• Communicate and liaise with iCTC departments to ensure proper recording of prepaid expenses, accruals, expenses and capital expenditures on a timely manner
• Assist with SOX 404B efforts in documenting and performing the key controls in areas of responsibility, as well as more broadly across the overall organization in support of the SOX 404B program
• Perform financial analysis and account reconciliations to ensure accuracy and completeness of financial results and information
• Review purchase orders, vendor invoices, contracts, manufacturing documents, department budgets and financial reports as needed
• Assist in inventory and costing process, variance analysis, SEC filings, Ad Hoc and management reports and presentations
• Ensure compliance with business filings, such as business annual report, state filings, business license renewal, etc.
• Special projects, as required

Education, Skills, and Knowledge

• Bachelor's or higher degree in Accounting
• 8+ years’ relevant work experience; Big 4 experience is preferable but not required
• CPA is a plus but not required
• Strong U.S. GAAP knowledge and working knowledge in SOX environment, technical accounting and financial reporting
• Industry experience in manufacturing, supply chain, plant operations is a plus; cost accounting experience is a plus
• Working knowledge of ERP systems, preferably NetSuite
• Onsite with flexibility
• Analytical, problem solving, flexible and “can do” attitude
• Ability to collaborate with business partners, team player and can work with less supervision
• Excellent skills in Excel; experience with MS Office Suite
• Strong organization skills and attention to detail
• Excellent communication and interpersonal skills with a customer service focus
• Ability to prioritize work and handle simultaneous assignments under tight deadlines in a fast-paced environment
• Excellent verbal and written communication skills with the ability to interact effectively

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.

Physical Demands and Activities Required 

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

 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 job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible.  Requires operating standard office equipment and keyboards.

#LI-onsite

Rotation Schedule:

Week 1: Shift A: Sunday to Tuesday from 5:00pm to 5:30am

Week 2 Shift A: Sunday to Wednesday from 5:00pm to 4:30am

Overview:

 Iovance Biotherapeutics is an immuno-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). TLead Aseptic Manufacturing Technician - Night Shift A Sun - Wed-5pm - 5:30am role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes. As an Aseptic Manufacturing Technician I, you will primarily be responsible for the following tasks: suite preparation for cell processing, material transfer, environmental monitoring, BSC runner duties, final product inspection, and final product cryopreservation in controlled rate freezers, for commercial and clinical use. 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.
As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualifications, as well as ISO class 5 (Grade A) cleanroom operations is strongly desired.
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 include weekends, evenings, and holidays, as needed (i.e. Shifts may be Sunday to Wednesday, Wednesday to Saturday days or nights). May be required to work overtime.

Essential Functions and Responsibilities:
•Develop a comprehensive understanding of and be able to proficiently execute 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.
•Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
•Preps:
oProvide operational support functions including:
▪Materials stocking and transfer.
▪Kit preparation.
▪Room readiness.
▪Equipment cleaning activities.
▪And inventory transactions using electronic inventory systems.
•Hallway:
oMaterial transfer.
oTumor receipt.
oChain of Information/Chain of Custody transactions.
oMaterial incubation.
oFeeder cell retrieval from liquid nitrogen (LN2) tanks.
oAble to perform final product visual inspection.
oFinal product cryopreservation in controlled rate freezers.
•BSCR:
oPerform biosafety cabinet (BSC) runner duties as assigned.
oBalance weight checks and operation.
oOperation of liquid repeater pump.
oOperation of tube sealers and welders.
oIncubator-use for cell culture.
•EM:
oPerform in-suite environmental monitoring during the day of process
oPerform document Environmental Monitoring duties using sample management electronic system.
•Miscellaneous:
oAble to train, pass and maintain gowning qualification.
oPerform logbook review.
oAttend the daily Tier 1 meeting and escalate issues/concerns at that forum to Area Management for further investigation.
oAbility to work in a team environment and independently as required.
oMust adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
oMust comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
oAdherence to production schedule while maintaining internal production priorities.
oPerform other duties as assigned.

Required Education, Skills, and Knowledge
•Bachelor’s degree or equivalent experience.
•Minimum 0-1 year of experience in biopharmaceutical-based GMP manufacturing operations, including, aseptic technique, aseptic liquid transfers, use of welders and sealers, BSC aseptic operations and associated downstream processing is a plus.
•Must be able to read, write and understand English especially for Good Documentation Practices.
•Proficiency in Microsoft (Excel, Word, Outlook and Teams).
•Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
•May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.
•Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
•Ability to build relationships quickly and credibly.
•Ability to work successfully in a fast-paced team-oriented environment and manage constant change.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request 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)
• Clarity of vision at near and mid-range, depth perception, and ability to identify and distinguish colors may be given a visual exam for visual acuity and color perception. Physical Demands and Activities Required:
•You 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-faced respirator for use of hazardous chemicals.
•Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, 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 50 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 deadlines.Work Environment:
•This position will work in both an office and a manufacturing setting.
•When in the cleanroom setting, must be able to work with various chemical/biochemical exposures with appropriate PPE.
•Potential exposure to noise and equipment hazards and strong odors.

#LI-onsite

Rotation Schedule:

Week 1: Shift B: Thursday to Saturday from 0700 to 1930

Week 2 Shift B: Wednesday to Saturday from 0700 to 1830

Overview

Iovance Biotherapeutics is an immuno-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). 

The Aseptic Manufacturing Technician I, role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes.

As an Aseptic Manufacturing Technician I, you will primarily be responsible for the following tasks: suite preparation for cell processing, material transfer, environmental monitoring, BSC runner duties, final product inspection, and final product cryopreservation in controlled rate freezers, for commercial and clinical use.

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.

As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualifications, as well as ISO class 5 (Grade A) cleanroom operations is strongly desired.

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 (1^st shift M-F); however, once the technician is trained, they will be assigned to a shift that include weekends, evenings, and holidays, as needed (i.e. Shifts may be Sunday to Wednesday, Wednesday to Saturday days or nights). May be required to work overtime. 

Essential Functions and Responsibilities:

• Develop a comprehensive understanding of and be able to proficiently execute 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.
• Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
• Preps:
  • Provide operational support functions including:
    • Materials stocking and transfer.
    • Kit preparation.
    • Room readiness.
    • Equipment cleaning activities.
    • And inventory transactions using electronic inventory systems.
  • Hallway:
    • Material transfer.
    • Tumor receipt.
    • Chain of Information/Chain of Custody transactions.
    • Material incubation.
    • Feeder cell retrieval from liquid nitrogen (LN2) tanks.
    • Able to perform final product visual inspection.
    • Final product cryopreservation in controlled rate freezers.
  • BSCR:
    • Perform biosafety cabinet (BSC) runner duties as assigned.
    • Balance weight checks and operation.
    • Operation of liquid repeater pump.
    • Operation of tube sealers and welders.
    • Incubator-use for cell culture.
  • EM:
    • Perform in-suite environmental monitoring during the day of process
    • Perform document Environmental Monitoring duties using sample management electronic system.
  • Miscellaneous:
    • Able to train, pass and maintain gowning qualification.
    • Perform logbook review.
    • Attend the daily Tier 1 meeting and escalate issues/concerns at that forum to Area Management for further investigation.
    • Ability to work in a team environment and independently as required.
    • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
    • Must comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
    • Adherence to production schedule while maintaining internal production priorities.
    • Perform other duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s degree or equivalent experience.
• Minimum 0-1 year of experience in biopharmaceutical-based GMP manufacturing operations, including, aseptic technique, aseptic liquid transfers, use of welders and sealers, BSC aseptic operations and associated downstream processing is a plus.
• Must be able to read, write and understand English especially for Good Documentation Practices.
• Proficiency in Microsoft (Excel, Word, Outlook and Teams).
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Ability to build relationships quickly and credibly.
• Ability to work successfully in a fast-paced team-oriented environment and manage constant change.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request 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)
• Clarity of vision at near and mid-range, depth perception, and ability to identify and distinguish colors may be given a visual exam for visual acuity and color perception.

Physical Demands and Activities Required:

• You 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-faced respirator for use of hazardous chemicals.
• Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, 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 50 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 deadlines. 

Work Environment: 

• This position will work in both an office and a manufacturing setting.
• When in the cleanroom setting, must be able to work with various chemical/biochemical exposures with appropriate PPE.
• Potential exposure to noise and equipment hazards and strong odors. 

#LI-onsite

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Schedule & Hours: 

Monday to Friday from 15:00-23:30

Overview

Iovance is an immune-oncology company focused on the development and commercialization of novel cancer immunotherapies based on 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 a commercially approved product along with multiple ongoing clinical trials in various phases for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors. The company is currently developing its commercial manufacturing capacity to support development and launch of these assets.

Essential Functions and Responsibilities

• Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Lead teams investigating minor, major and critical nonconformances and deviations, including gathering information through structured root cause analysis. Draft and revise deviation reports as needed to assure that deviations are addressed in a timely manner.
• Own and manage change controls associated with manufacturing areas and equipment.
• Participate in technology transfer, conference calls and sharing of technical information.
• Coordination of front-end document requests with supporting departments.
• Assure that Deviations and CAPAs are addressed in a timely manner, and that Batch Records revisions are reviewed and approved in a timely manner.
• Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of document review and revision.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Attends the weekly management meeting to discuss timelines and weekly priorities.
• Contribute to projects to ensure timely initiation and completion of work.
• May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
•Troubleshoot issues and prioritize workload to solve moderately complex problems, including on the floor troubleshooting support as needed.

•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.
•Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements. Review data as generated/collected by less experienced technical staff.
• 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

May require up to 10% travel, based on business need.

Required Education, Skills, and Knowledge

• Minimum bachelor’s degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
•Minimum of 2 years of experience in biopharmaceutical based GMP manufacturing operations.
•An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•Demonstrated strong technical knowledge of aseptic processing in cleanroom environments is a must.
•Ability to build relationships quickly and credibly. Provide consistent, excellent support to staff, with the ability to influence large teams within the manufacturing department representing a variety of personalities and experience levels.
•Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
•Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
•Ability 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.
•Excellent presentation skills, both written and verbal.
•Understands and complies with quality standards and requirements as documented.
•Must have strong written and verbal communication and organizational skills.
•Strong computer skills, problem solving and attention to detail.
•Familiarity with data and sample management required (LIMS/MES).
•Able to work independently with minimal supervision.
•Must adhere to Iovance Biotherapeutics core values, policies, procedures, and business ethics.
•This position is currently for regular work week hours (1st shift M-F).
•Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).

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.

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.
•Able to stand and/or walk 90% (and sit 10%) 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 deadlines.

Work Environment

•This position will work in both an office and a manufacturing cleanroom setting.
•When in the lab, must be able to work in cleanroom 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.

#LI-onsite

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

Reporting to the Senior Director, Finance Plant Controller, this position is integral to the continued and planned future growth of the Company’s Cell Therapy Manufacturing Center (“iCTC”) and capabilities. This is a hands-on role with a range of accounting and finance duties which include performing month end close activities in accordance with GAAP accounting for inventory, capital expenditures and fixed asset accounting, monitoring and adhering to audit and SOX compliance requirements and interaction with Internal Audit and external auditors, management reporting, and supervisory responsibilities for one direct report.  The Senior Manager will work closely with Corporate Accounting, Manufacturing Finance, Internal Audit and Global FP&A teams to support the monthly close processes and quarterly external financial reporting as well as to assure strong linkage of data reported and budgeted results. 

Essential Functions and Responsibilities

• Own and support internal control documentation from testing through execution ensuring compliance with established controls, working with the Internal Audit team to continuously improve & strengthen controls.
• Support any internal and external financial audits including preparing monthly and quarterly PBC schedules to support the audit and interim reviews, in addition to working with external audit firm on deliverables and related questions.
• Perform core GL operations including account reconciliation analysis, review journal entries and review accounting classifications for capital and fixed asset accounting, inventory valuation, and related reserves, in accordance with U.S. GAAP.
• Perform analytical and trend analyses on income statement and balance sheet accounts and ensure all significant fluctuations are properly explained and supported
• Oversee yearly Fixed Asset physical inventory process with the operations team.
• Prepare & analyze management reporting for the iCTC,
• Collaborate with the Global FP&A team to participate in the development of underlying assumptions for annual budget process and updated forecast cycles for the iCTC & monitor results, actuals versus budgets, forecasts, and prior year.
• Proactively identify and analyze opportunities to improve results and financial processes.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Special projects and miscellaneous duties as assigned.

Travel

• Ability to travel on an as-needed basis to other worksites. 

Required Education, Skills, and Knowledge

• CPA (or equivalent) and/or Big Four Audit firm experience strongly preferred.
• 9+ years of progressive experience in accounting with general accounting focus, cost accounting and inventory reporting experience a plus.
• Strong understanding and significant experience in application of US GAAP, SOX, and financial accounting.
• Expertise in Sarbanes-Oxley (SOX) requirements and best practices.
• Excellent interpersonal and communication skills, with the ability to build partnerships across functions.
• People management skills
• NetSuite experience is a plus.
• Advanced Microsoft Excel, Word and PowerPoint skills.
• Detail oriented with insight to determine applicability of big picture.
• Strong work ethic and demonstrated ability to independently prioritize workload based on organizational needs/demands. Operates with a sense of urgency, as appropriate.

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.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information. 

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 job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible.  Requires operating standard office equipment and keyboards.

#LI-onsite

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Shift: Wednesday to Saturday - Day shift

Overview

The Senior Quality Control Analyst in Microbial ID Team supports Iovance’s Cell Therapy Center (iCTC) quality control testing operations.  The quality control testing programs include in-process and final drug product microbial testing such as Endotoxin, Gram Stain, Mycoplasma Testing, Microbial Identifications and Sterility techniques. This work shift is from Wednesday to Saturday. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to ensure the testing process is completed. Applicants must have experience in Microbial Identification.

Essential Functions and Responsibilities:

• Lead Microbial Identification testing function
• Lead Microbial Banking related Initiatives
• Perform daily cGMP quality control laboratory microbiological testing activities at the iCTC facility.
• Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
• Perform all activities for cGMP compliance.
• Lead thorough cGMP investigations for out-of-specification test results.
• Lead technical problem-solving.
• Operate at a consistent and exemplary efficiency level, producing high-quality and accurate results.
• 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.

 Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Minimum eight (8) years of experience in the pharmaceutical industry within a Quality Control role
• Skills and knowledge in performing microbial ID testing
• Successfully interface with multi-disciplined teams
• Extremely detail-oriented with strong technical skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• High level of ownership and accountability
• Demonstrate a sense of urgency; ability to recognize time sensitivity.

Preferred Education, Skills, and Knowledge

• Experience with cell therapy products is a plus.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

Physical Demands and Activities Required:

• Must be able to work in a lab setting with biohazards / various chemicals.
• 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.
• Must be able to lift and carry objects weighing up to 45 pounds

Mental:

Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines.

Work Environment:

This position will work in both an office and a QC laboratory 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.

#LI-onsite

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Supervisor for Aseptic Manufacturing oversees the production process to ensure that all materials are produced safely and follow the company's standards. This position requires timely document review and ensuring all targets are met. In addition, the supervisor will be responsible for developing staff and implementing an effective "First-time right" program to meet Iovance's growing demands. The successful candidate will also help onboard new team members and manage deviations and CAPAs for the training and learning team. It is crucial that the supervisor has innovative technical knowledge and contributes significantly to the overall manufacturing operation. As a leadership team member for autologous cell therapy manufacturing operations, a background in cell culture and manufacturing in ISO class 5 cleanrooms is necessary.

Essential Functions and Responsibilities

• Supervision and Development direct reports (operators), mentoring/coaching to motivate and mentor peers/ staff to foster a culture of continuous improvement and operational excellence.
• Schedule and coordinate day-to-day activities, ensuring conformance to the daily schedule.
• Develop a comprehensive understanding of the current production process, as this role is viewed as a subject matter expert within a specific area. Significant experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility are required.
• Provide oversight of the manufacturing process, ensuring technicians follow cGMP practices and utilize proper aseptic techniques.
• Review batch documentation and logbooks for completeness and accuracy.
• Ability to work under limited supervision and handle problems of a more complex nature.
• Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of the operation.
• Establish objectives and conduct performance reviews, monitor progress toward goals, and provide timely feedback to Management.
• Author and revise documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.
• Ensure the department understands and complies with quality standards and requirements as documented.
• Ensure efficient operations and compliance with cGMPs and safety regulations. • Work in a cleanroom with biohazards, human blood components, and chemicals • 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 - 10%

Required Education, Skills, and Knowledge

• Minimum B.S. in biology, biochemistry, bioengineering, related technical field, or equivalent industry and technical experience.
• Minimum of 5 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing. A minimum of 2 years in a Lead/Leadership/Supervisory Role is desired.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
• Strong knowledge and experience of the end-to-end learning process, i.e., learning needs assessment, program design and delivery, and learning evaluation and training effectiveness assessment.
• Demonstrates strong oral and written communication skills and actively contributes to training, report generation, and documentation (batch records, deviations, etc.). Strong technical writing ability is required.
• Experience leading “development” initiatives, i.e., training, coaching, and learning initiatives.
• Ability to mentor and provide best practices to other team members.
• Ability to build relationships quickly and credibly. Provide consistent, excellent support to the entire staff, with the ability to manage and influence large teams within the manufacturing environment (potentially 50+ employees) representing a variety of personalities and experience levels.
• Proactive, results-oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
• Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
• Ability 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.
• Remains current regarding Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies production methods to address compliance issues fully.

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

• 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.
• 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 manage 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.

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