Scientist I, Late-Stage Process Development

Job Description

Job Ttitle: Scientist I, Late-Stage Process Development

Company: Iovance Biotherapeutics


Description: OverviewThis position will assist the Director of Late-Stage Process Development in planning, coordinating, executing, and overseeing process development and manufacturing related activities (incl technology transfer) which includes proof of concept, feasibility, development, qualification, and validation studies across manufacturing sites.The Scientist will work with a team to perform activities in process characterization, process improvements, and process automation and technology development projects related to cell therapy manufacturing. The Scientist is a cell therapy development subject matter expert that will actively collaborate with Research, MSAT, Quality Engineering, Manufacturing Operations, Quality Control, and Regulatory. Additionally, you will provide support to all late-stage process development projects and requires relevant experience on development/manufacturing of cell therapy and gene modified cell therapy products, in authoring and reviewing IND / BLA Module 3 source documents, and in working with 3rd party vendors for manufacturing and testing in development and GMP settings.Working knowledge of cGMP practices is essential as the position will support current and future clinical trials, as well as commercial manufacturing. 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, in project management, and in managing 3rd party relationships to contractual terms is desirable.Essential Functions and Responsibilities:

• Lead pipeline/development projects, write-up of protocols for small- and full-scale PD optimization experiments, schedule, execute, and author/review reports, 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.
• Perform studies including automation to characterize and identify critical process parameters in bulk media preparation both in small- and full-scall PD studies.
• Assist in the design and execution of media stability studies for semi-automated bulk media preparation and determination of media expiration for commercial manufacture of drug product.
• Contributes to the development of manufacturing strategies for resolving complex issues related to new process transfers to manufacturing sites.
• Assist team to design, execute, and support laboratory process development studies involving a variety of protocols and techniques to develop a thorough understanding of operating and performance parameters of cell therapy processes.
• Perform lab activities in process automation and development of process technology.
• Development of new processes or refinement of existing ones to optimize the manufacturing process, working with product pipeline at various stages of development, liaising with pre-clinical research team and conduct/research feasibility for scale up.
• Testing new automation equipment/reagents to improve efficiency and reduce costs, plan and conduct independent experiments, validating the new processes and showing that there are improvements, and keeping up to date with relevant scientific and technical developments.
• 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 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, setting preventative measures in place, 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 identification of patentable inventions.
• Maintain high level of professional expertise through regular consulting of scientific literature and attendance of training and/or scientific seminars.
• Execute corporate and department objectives to completion through strong collaboration with a broad range of internal and external functions and levels of management.
• 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.
• 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:

• PhD with 2-5 years of industry experience or master’s degree with 9+ years of industry experience in Chemical and Biomedical Engineering, Immunology or relevant 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 working in various Quality Systems, understanding of facility technology, system troubleshooting, CAPA’s and change controls.
• Hands-on experience with large-scale tissue culture of cell therapies (e.g., automatic cell washing/separation, cell separation techniques, use of bioreactors, dose formulation) and working in a GMP-compliant cleanroom environment is a requirement.
• Prior experience developing and supporting cell therapy manufacturing processes.
• Broad knowledge of flow cytometry and immunoassays, optimization, and analysis is preferred.
• Excellent organizational and record-keeping skills are necessary.
• Ability to meet objectives and perform with a high degree of accuracy.
• Expert in Microsoft Office programs.
• Must be capable of working in a fast-paced, collaborative environment and manage multiple concurrent projects with a high degree of independence.
• Strong interpersonal, written, and oral communication skills are required.
• Ability to prepare high quality presentations and speak, present data, and defend approaches in front of audiences, including management or inspectors.
• Excellent verbal and written (such as writing batch record, SOP, scientific report) communication skills required.
• Excellent technical writing skills with proficient spelling, grammar, and typing skills.
• Ability to perform gowning activities and enter the manufacturing plant.
• Flexibility to work weekends and holidays is required.

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 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 when in a laboratory setting, i.e., safety glasses, lab coats, and closed-toed shoes.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 EnvironmentThis position will work in both an office and a laboratory setting. When in the lab, there may be a risk of exposure to hazardous or biological waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning, and/or disposal of contaminated areas and waste.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 .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 .#LI-Onsite

Salary:

Location: Philadelphia, PA

Date: Wed, 05 Feb 2025 08:57:28 GMT


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