Current jobs related to Associate Director, Process Development - Philadelphia - Iovance Biotherapeutics Inc

  • Senior Director of Process Development

    1 week ago

    Philadelphia, Pennsylvania, United States Jobot Full time

    {"Job Title": "Senior Director of Process Development", "Job Summary": "We are seeking a highly experienced Senior Director of Process Development to join our team at Jobot. As a key member of our process development team, you will be responsible for leading the development of robust, high-performing processes for gene therapy candidates from early stages...

  • Senior Director of Process Development

    5 days ago

    Philadelphia, Pennsylvania, United States Jobot Full time

    Job SummaryWe are seeking a highly experienced Senior Director of Process Development to join our team at Jobot. As a key member of our organization, you will be responsible for leading the development of robust, high-performing processes for gene therapy candidates from early stages through regulatory approval.Key ResponsibilitiesDevelop and implement...

  • Associate Director of Development

    1 week ago

    Philadelphia, Pennsylvania, United States Northern Children Full time

    Job SummaryThe Associate Director of Development at Northern Children's Services is a key role in advancing the organization's fundraising efforts and enhancing donor relations. This position supports major fundraising campaigns, cultivates and manages relationships with individual donors, foundations, and corporate sponsors, and oversees vendor...

  • Associate Director of Development

    4 weeks ago

    Philadelphia, United States Northern Children's Services Full time

    Job DescriptionJob DescriptionJoin Our Team as Associate Director of Development and help make a difference in the lives of children, youth, and families!Job SummaryAre you passionate about supporting the healthy development of children, youth, and families for a brighter future?Look no further! At Northern Children’s Services (Northern), every role in the...

  • Process Development Associate Scientist

    11 hours ago

    Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    Job Title: Process Development Associate ScientistWe are seeking a highly skilled Process Development Associate Scientist to join our team in the Gene Therapy Program at the University of Pennsylvania. As a key member of our Vector Core, you will be responsible for leading process development projects for upstream and/or downstream manufacturing of viral...

  • Associate Director of Development

    2 days ago

    Philadelphia, Pennsylvania, United States Northern Children Full time

    Job SummaryThe Associate Director of Development at Northern Children's Services is a key role in advancing the organization's fundraising efforts and enhancing donor relations. This position supports major fundraising campaigns, cultivates and manages relationships with individual donors, foundations, and corporate sponsors, and oversees vendor...

  • Associate Director of Development

    2 days ago

    Philadelphia, Pennsylvania, United States Drexel University Full time

    Job SummaryThe Associate Director of Development is a key member of the Institutional Advancement team at Drexel University, responsible for cultivating and soliciting philanthropic support from donors, alumni, and friends of the College of Nursing and Health Professions.Key ResponsibilitiesDevelop and implement a comprehensive outreach plan to engage and...

  • Associate Director of FP&A

    6 days ago

    Philadelphia, United States Robert Half Full time

    Job DescriptionJob DescriptionStable client located within the South Philadelphia area is looking to add an Associate Director of FP& A to their finance department. This role will consist of providing assistance with variance analysis, strategic insights, providing financial guidance by managing the monthly/annual budgeting process, preparing monthly and...

  • Development Director

    2 days ago

    Philadelphia, Pennsylvania, United States Pennsylvania Voice Full time

    About Pennsylvania VoicePennsylvania Voice is a 501(c)3 organization that serves as the table for over 55 state and local-based organizations. Our mission is to create a more accessible, inclusive, and representative democracy by amplifying the voices, leadership, and expertise of communities that have historically experienced deliberate barriers to civic...

  • Director of Community Development

    4 weeks ago

    Philadelphia, United States Friends of the Rail Park Full time

    Reporting to the Executive Director, The Director of Community Development (DCD) supports the development and execution of Friends of the Rail Park’s (FRP) equitable development strategy. The DCD’s role is to manage the strategy, planning process, and implementation of the Rail Park Equitable Development Agenda, and where appropriate, at the discrete...

  • Development Director

    4 days ago

    Philadelphia, Pennsylvania, United States ActionAIDS Full time

    Job Title: Development DirectorJoin Action Wellness, a mission-driven nonprofit, in a dynamic role that combines fundraising, event planning, and grant writing. As our Development Director, you will be responsible for leading our fundraising efforts, identifying and cultivating major gift prospects, and developing a comprehensive plan to achieve our...

  • Associate Director of Administration

    22 hours ago

    Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    Job Title: Associate Director of AdministrationJob Summary:The Associate Director of Administration will oversee the non-clinical and support clinical administrative and financial activities of the Division of Pulmonary, Allergy and Critical Care (PACC) in the Department of Medicine, including a $36M annual budget in grants, gifts, endowments, and other...

  • Development Director

    2 months ago

    Philadelphia, United States ActionAIDS Full time

    Job DescriptionJob DescriptionPOSITION TITLE: Development Director DEPARTMENT: DevelopmentREPORTS TO: Executive DirectorTYPE: Full Time, ExemptPosition Summary: The Development Director is a dynamic, creative, and organized individual who is interested in helping Action Wellness, a mission-driven nonprofit, thrive and grow. This employee will be responsible...

  • Development Director

    3 weeks ago

    Philadelphia, United States ActionAIDS Full time

    Job DescriptionJob DescriptionPOSITION TITLE: Development Director DEPARTMENT: DevelopmentREPORTS TO: Executive DirectorTYPE: Full Time, ExemptPosition Summary: The Development Director is a dynamic, creative, and organized individual who is interested in helping Action Wellness, a mission-driven nonprofit, thrive and grow. This employee will be responsible...

  • Tax Returns Processing Director

    2 weeks ago

    Philadelphia, Pennsylvania, United States Office of the Chief Financial Officer Full time

    Director of Tax Returns ProcessingThe Office of the Chief Financial Officer (OCFO) is seeking a highly skilled and experienced professional to lead the Tax Returns Processing team. As the Director of Tax Returns Processing, you will be responsible for planning, coordinating, and implementing a portion of the District's tax program.Key Responsibilities:Manage...

  • Tax Returns Processing Director

    2 weeks ago

    Philadelphia, Pennsylvania, United States Office of the Chief Financial Officer Full time

    Director of Tax Returns ProcessingThe Office of the Chief Financial Officer (OCFO) is seeking a highly skilled and experienced professional to lead the Tax Returns Processing team. As the Director of Tax Returns Processing, you will be responsible for planning, coordinating, and implementing a portion of the District's tax program.Key Responsibilities:Manage...

  • Biologics Development Director

    6 days ago

    Philadelphia, Pennsylvania, United States EPM Scientific Full time

    Director of Biologics DevelopmentLocation: The Greater Philly RegionSalary: $200,000 + Benefits + BonusEPM Scientific is seeking a seasoned Director to lead their Drug Product Development team in the Greater Philly region. The ideal candidate will have a strong background in biologics development, including experience with mAbs, ADCs, and proteins. This role...

  • Biologics Development Director

    2 hours ago

    Philadelphia, Pennsylvania, United States EPM Scientific Full time

    Director of Drug Product Development- BiologicsAt EPM Scientific, we are seeking a seasoned Director to lead our Drug Product Development team in the Greater Philly Region. This is an exceptional opportunity for a highly skilled professional to drive the development of our extensive traditional biologic pipeline, from early to late stages of development.Key...

  • Process Development Scientist

    3 weeks ago

    Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    Job DescriptionThe Gene Therapy Program (GTP) is seeking a highly skilled Process Development Associate Scientist to join our team. As a key member of our laboratory, you will be responsible for leading process development projects for upstream and/or downstream manufacturing of viral vectors.Key Responsibilities:Independently lead lab studies to develop...

  • Director of Development

    4 days ago

    Philadelphia, Pennsylvania, United States Midatlantic Employers' Association Full time

    Job Title: Director of DevelopmentAt Bebashi - Transition to Hope, we are seeking a highly skilled and experienced Director of Development to join our dynamic team. As a key member of our leadership team, you will play a pivotal role in shaping the future of our organization and driving our mission forward.Key Responsibilities:Strategic Fundraising...

Associate Director, Process Development

4 months ago

Philadelphia, United States Iovance Biotherapeutics Inc Full time
Job DescriptionJob DescriptionSalary:

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. 

 

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. 


#LI-onsite