Associate Director, Process Development

Job Description

Job Description

Salary :

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 : U pdated resume

We are Hiring! We look forward to seeing you at the Job Fair.

Overview

This position will assist the Executive Director of Process Development in planning, coordinating, and overseeing process development and manufacturing-related activities throughout the product life cycle, which includes proof of concept, feasibility, development, qualification, and validation studies across manufacturing sites.

As the Associate Director (AD), Process Development, you will be the go-to expert in process characterization, process improvements, process automation, and technology development projects related to cell therapy manufacturing.

Your expertise will be instrumental in our active collaboration with Research, MSAT, Quality Engineering, Manufacturing Operations, Quality, and Regulatory.

The Associate Director will provide support to all late-stage process development projects. This role requires relevant experience in the development / manufacturing of cell therapy and gene-modified cell therapy products, authoring and reviewing IND / BLA Module 3 source documents, and working with third-party vendors for manufacturing and testing in development and GMP settings.

In addition to your technical expertise, you will also be responsible for personnel management of a small team of direct reports.

Your leadership skills will be crucial in guiding and developing your team. Specific experience in unmodified and genetically modified TIL, mRNA manufacturing and use in T cell Transfection, engineered T cell receptor (TCR) T cells, and / or gene-edited T cells, project management, and managing third-party relationships to contractual terms is desirable.

Essential Functions and Responsibilities

Lead pipeline / development projects, write up protocols for small- and full-scale PD optimization experiments, schedule, execute, and author / review reports, and provide data for IND submission.

Authors, reviews, and approves risk assessments. Author protocols and associated reports per Good Documentation Practices.

• Utilizes strong operational excellence / lean principles, business acumen, quality-mindedness, and exceptional communication skills to develop streamlined, efficient, and robust processes and to affect positive change.
• Contributes to developing manufacturing strategies for resolving complex issues related to new process transfers to manufacturing sites.
• Design, execute, and support laboratory process development studies involving a variety of protocols and techniques to develop a thorough understanding of the operating and performance parameters of cell therapy processes.
• Perform lab activities in process automation and development of process technology.
• Provide technical leadership and scheduling for the team to ensure deliverables, coordination of external testing required, and data collection.
• Train new and junior associates / scientists in experimental design, troubleshooting, and equipment operation. Serve as a techniques master, training supervisor, and knowledge resource for process development.
• Work closely with partner laboratories and manage various aspects, from selection, contract negotiations, tech-transfer, process development, stability, and scale-up to GMP manufacturing of critical materials and reagents.
• Collaborate with the MSAT team and support Tech Transfer activities for IND submission.
• Lead / Co-Lead projects associated with external vendors and coordination of external testing required and data collection.
• Ensure successful manufacturing production runs by assessing risk, implementing preventative measures, and investigating and troubleshooting equipment and process issues.
• Maintain up-to-date training and knowledge on automation and analytical tools / equipment.
• Perform robust analysis and statistical evaluation of data for results-driven presentation and cross-functional discussion.
• Contribute to scientific publications and to the identification of patentable inventions.
• Maintain a high level of professional expertise through regular consulting of scientific literature and attending training and / or scientific seminars.
• Complete corporate and department objectives through strong collaboration with a wide range of internal and external functions and management levels.
• Ensure compliance and maintenance of lab safety, environment, and quality.
• Operate at a consistent and exemplary level of efficiency, producing high-quality and accurate results.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• PhD with 7+ years of industry experience or master’s degree with 10+ years of industry experience in the Chemistry or Biology field.
• GMP or Quality experience with proficiency with regulatory compliance and FDA guidelines for Title 21 Code of Federal Regulations related to current Good Manufacturing Practices (cGMP) and Good Clinical (Research) Practices (GCP), ICH standards for analytical test methods as required.
• Prior experience developing and supporting cell therapy manufacturing processes.
• Knowledge of medical terminology and intellectual capacity to use judgment and critical thinking skills to ensure that the data are accurate, logical, and consistent with internal and regulatory reporting requirements are required.
• Must be capable of working in a fast-paced, collaborative environment and managing multiple concurrent projects with a high degree of independence.
• Strong interpersonal, written, and oral communication skills are required.
• Ability to prepare high-quality presentations, speak present data, and defend approaches in front of audiences, including management or inspectors.
• Technical writing must be at an advanced level with proficient spelling, grammar, and typing skills. Ability to understand and teach technical writing skills and minimize the risk of misinterpretation.
• Exhibits leadership behaviors, including collaboration for results and developing / executing strategy.
• Strong ability to influence in a team environment and collaborate with peers.
• Must be able to create an environment that encourages continuous improvement, best practices, and appropriate risk-taking.
• Must have experience working in various Quality Systems, understanding facility technology, system troubleshooting, CAPA, and change controls.
• Ability to perform gowning activities and enter the manufacturing plant.
• Project Management experience with prior experience managing multiple assignments and processes while developing practical and thorough solutions for complex issues.
• Ability to meet objectives and perform with a high degree of accuracy. Expert in Microsoft Office programs.

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 move to and from the office to the lab located on separate floors and move about the office and lab as needed.
• Must be able to remain in a stationary position, standing or sitting for prolonged periods of time.
• Must be able to grasp with both hands, perform repetitious actions such as pinch with thumb and forefinger, turn with hand / arm, and reach above shoulder height.
• Must be able to use several types of laboratory equipment and pipettes for extended periods.
• Must be able to work on a tablet or computer typing for 50% of a typical working day.
• Must be able to move and lift 20 pounds multiple times daily.
• Must be able to use near vision to view samples at close range.
• Wear proper personal protective equipment, such as safety glasses, lab coats, and closed-toed shoes, when in a laboratory setting.
• 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.

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.

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