Quality Control Specialist Operations Strategy Contract to Hire

Overview

Iovance Biotherapeutics is a growing latestage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Specialist Quality Control Operations Strategy who will support the longterm 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 is able to work on continuous improvement in dynamic environments.

Essential Functions and Responsibilities

• Collaborate closely with fellow specialists under the supervision of 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 QCs 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.
• Provide support to Specialists to lead and manage management systems for the Quality Control organization
• 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

• Bachelors degree in a relevant discipline (biological sciences or equivalent)with a minimum of 2 years of experience in the biopharmaceutical industry within a cGMP Quality Control role or a masters degree in a relevant discipline
• 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 multidisciplined teams
• Extremely detailoriented 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.

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 Sit for an extended amount of time in front of the computer.

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 deadline

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 equalopportunity 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 e.

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