Manager, Analytical Development (Cell Therapy)

Overview 

The Manager, Analytical Development will lead projects at CTLs/CDMOs that focus on the development, qualification, validation, verification and comparability of analytical assays and processes for early to late phase clinical products as well as for commercial final drug product (DP) supply. This position will support cellular manufacturing, process development and optimization, product characterization, analytical development, technology transfer activities as well as release and stability testing for Tumor Infiltrating Lymphocyte (TIL) products used in clinical trials for the treatment of solid tumors sponsored by Iovance Biotherapeutics. Experience in developing CMC packages for IND /BLA /MAA submissions and other Regulatory engagements for cell and gene therapy products is required.

Essential Functions and Responsibilities

• Lead and provide scientific oversight and technical advisement for bioassays, safety assays, and bioanalytical studies including qualification, validation, verification, and comparability utilizing a variety of analytical techniques and instrumentation. 
• Subject matter expertise in developing and performing analytical methods and data analysis of results for various analytical methodologies including but not limited to genome integrity, genotyping for allelic KO, WGS, NGS, gene expression, immunophenotyping, flow cytometry, replication competent lentivirus, PCR based methods (Host Cell DNA, vector copy number etc.), protein expression, ligand-binding assays (ELISA, MSD etc.), cell-based potency assays and cytotoxicity assays
• Expertise in safety assay testing for product release and raw material qualification including but not limited to bioburden, sterility, endotoxin, mycoplasma, and bacteriophage.
• Lead study design for analytical runs and investigations, data analysis, as well as culmination and presentation of data for peer review and in support of Regulatory agency submissions. 
• Provide project management oversight of and demonstrate ability to troubleshoot external contracts for analytical method development and validation, product release and stability testing, raw material and excipient release testing, critical reagent qualification and MCB/WCB qualification. 
• Strong technical writing ability to author and review SOPs, protocols, and associated reports, quality documents, Regulatory submissions per Good Documentation Practices (GDP) and quality standards. 
• Maintain a high level of professional expertise through regular consulting of scientific literature and attendance of training and/or scientific seminars. 
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. 
• Perform miscellaneous duties assigned.

Travel – 10% of the time

Required Education, Skills, and Knowledge:

• PhD with 2+ years of industry experience, MS + 5 years industry experience or BS with 7+ years of industry experience with cell and gene therapy products with a focus in Immunology /Molecular Biology / Genetics field.
• Possess a solid understanding of verification and validation of assays supporting clinical and commercial release of drug product as well as comparability, release and stability testing per appropriate regulatory guidance and standards.
• Quality control and GMP experience is required.
• Prior experience developing and supporting cell and or gene therapy drug products. Understanding of regulations and guideline documents (cGMP / ICH / USP /EP pharmacopeia) required 
• Ability to apply critical thinking skills to evaluate technical requirements and effectively communicate (written and oral) findings. 
• Prior experience with project management tools managing external contracts, demonstrating effective communication and documentation skills, tracking to timelines and milestones in scope and on budget. 
• Must be capable of working in a fast-paced, collaborative environment and manage multiple concurrent projects with competing priorities, with a high degree of independence and agility. 
• Strong interpersonal, written, and oral communication skills are required. 
• Must be organized, able to multi-task, and be a team player.

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 remain in a stationary position standing or sitting for prolonged periods of time. 
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. 
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

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 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 careers@iovance.com.

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