Iovance Biotherapeutics
Quality Control Specialist, Operations Strategy [Contract to Hire]
Iovance Biotherapeutics, Phila, Pennsylvania, United States, 19117
Iovance is hosting an onsite Job Fair.
Where:
Iovance Cell Therapy Center (iCTC)
Location:
300 Rouse Blvd Philadelphia, PA 19112
Date:
Monday, June 24, 2024
Time:
12pm to 6pm (EDT)
What to bring:
Updated resume
We are Hiring! We look forward to seeing you at the Job Fair.
OverviewIovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Specialist, Quality Control, Operations Strategy, who will support the long-term sustainability of the Lean Labs initiative within the Iovance Quality Control Department. This role will assist with identifying and driving continuous improvement in collaboration with QC functional areas, and the creation and maintenance of the QC workforce models to ensure patient demand is met. In addition, this role will support strategic planning for the implementation of pipeline products and projects in the QC department. This position is responsible for maintaining knowledge of lean labs principles and various operational excellence strategies within the department by providing lean focused leadership, training, coaching, and mentorship to QC personnel. The Specialist, Quality Control, Operations Strategy must have experience with lean labs, different operational excellence concepts, tier governance, workforce modeling and planning, and be a highly collaborative team player who works well in dynamic environments.
Essential Functions and Responsibilities
Collaborate closely with the Senior Manager, Quality Control, Operations Strategy as well as other QC functions to strategically plan future projects such as new product introduction, laboratory capacity planning, facility transfers and expansions, and other pipeline projects.
Develop and upkeep planning tools to allow for site growth within the quality control organization such as headcount capacity models for increased manufacturing capabilities and onboarding of new quality control assays, tests, and processes that contribute to the release of lots and materials.
Assist with deployment, hypercare, change management, and maintenance of ongoing lean labs implementation in Quality Control.
Maintain QC workforce models.
Monitor and routinely evaluate KPIs, metrics, heat maps, and A3s to measure performance of quality functional areas.
Assist with the development of QC’s lean capabilities by facilitating training and coaching of problem solving using the lean tool kit.
Collaborate with other continuous improvement professionals to cascade needs and projects throughout the business and achieve solutions that drive positive business 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 (3) years of experience in the biopharmaceutical industry within a cGMP Quality Control role
Experience with different operational excellence concepts including (but not limited to) lean labs, lean practitioner, tier governance, coaching kata, gemba walks, job instruction, Kaizen, A3 problem solving, change management, leader standard work.
Fundamental knowledge of Quality Control operational and laboratory practices including, but not limited to, microbiology, analytical testing, sample management, quality records, and training.
Advanced proficiency in MS Office (Word, Excel, Powerpoint, Visio)
Successfully interface with multi-disciplined teams
Extremely detail-oriented with strong written, and verbal communication skills
Ability to effectively balance multiple priorities involving aggressive timelines at a high level of productivity
Advanced strategic planning and implementation
Demonstrate sense of urgency; ability to recognize time sensitivity
Flexible and adaptable style with an eagerness to take on challenges
Problem solver who not only identifies issues but leads efforts to resolve them
Preferred Education, Skills, and Knowledge
Experience with cell therapy products is a plus.
Physical Demands and Activities Required
Must be able to sit for an extended amount of time in front of the computer.
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 an office, with occasional visits to the Quality Control labs.
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.
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 individual’s 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
careers@iovance.com .
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 our
Candidate Privacy Notice .
#LI-Onsite
#J-18808-Ljbffr
Where:
Iovance Cell Therapy Center (iCTC)
Location:
300 Rouse Blvd Philadelphia, PA 19112
Date:
Monday, June 24, 2024
Time:
12pm to 6pm (EDT)
What to bring:
Updated resume
We are Hiring! We look forward to seeing you at the Job Fair.
OverviewIovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Specialist, Quality Control, Operations Strategy, who will support the long-term sustainability of the Lean Labs initiative within the Iovance Quality Control Department. This role will assist with identifying and driving continuous improvement in collaboration with QC functional areas, and the creation and maintenance of the QC workforce models to ensure patient demand is met. In addition, this role will support strategic planning for the implementation of pipeline products and projects in the QC department. This position is responsible for maintaining knowledge of lean labs principles and various operational excellence strategies within the department by providing lean focused leadership, training, coaching, and mentorship to QC personnel. The Specialist, Quality Control, Operations Strategy must have experience with lean labs, different operational excellence concepts, tier governance, workforce modeling and planning, and be a highly collaborative team player who works well in dynamic environments.
Essential Functions and Responsibilities
Collaborate closely with the Senior Manager, Quality Control, Operations Strategy as well as other QC functions to strategically plan future projects such as new product introduction, laboratory capacity planning, facility transfers and expansions, and other pipeline projects.
Develop and upkeep planning tools to allow for site growth within the quality control organization such as headcount capacity models for increased manufacturing capabilities and onboarding of new quality control assays, tests, and processes that contribute to the release of lots and materials.
Assist with deployment, hypercare, change management, and maintenance of ongoing lean labs implementation in Quality Control.
Maintain QC workforce models.
Monitor and routinely evaluate KPIs, metrics, heat maps, and A3s to measure performance of quality functional areas.
Assist with the development of QC’s lean capabilities by facilitating training and coaching of problem solving using the lean tool kit.
Collaborate with other continuous improvement professionals to cascade needs and projects throughout the business and achieve solutions that drive positive business 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 (3) years of experience in the biopharmaceutical industry within a cGMP Quality Control role
Experience with different operational excellence concepts including (but not limited to) lean labs, lean practitioner, tier governance, coaching kata, gemba walks, job instruction, Kaizen, A3 problem solving, change management, leader standard work.
Fundamental knowledge of Quality Control operational and laboratory practices including, but not limited to, microbiology, analytical testing, sample management, quality records, and training.
Advanced proficiency in MS Office (Word, Excel, Powerpoint, Visio)
Successfully interface with multi-disciplined teams
Extremely detail-oriented with strong written, and verbal communication skills
Ability to effectively balance multiple priorities involving aggressive timelines at a high level of productivity
Advanced strategic planning and implementation
Demonstrate sense of urgency; ability to recognize time sensitivity
Flexible and adaptable style with an eagerness to take on challenges
Problem solver who not only identifies issues but leads efforts to resolve them
Preferred Education, Skills, and Knowledge
Experience with cell therapy products is a plus.
Physical Demands and Activities Required
Must be able to sit for an extended amount of time in front of the computer.
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 an office, with occasional visits to the Quality Control labs.
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.
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 individual’s 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
careers@iovance.com .
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 our
Candidate Privacy Notice .
#LI-Onsite
#J-18808-Ljbffr