Manager, Analytical Development (Protein Sciences)

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 commercial final drug product (DP) supply as well as early to late phase clinical products. This position will support protein therapeutics manufacturing, release and stability testing, product characterization, process optimization and product life-cycle management for both commercial, global product supply, and early phase products related to Tumor Infiltrating Lymphocyte (TIL) clinical trials for the treatment of solid tumors sponsored by Iovance Biotherapeutics. Experience working in a cGMP environment supporting global product release within the quality management system adhering to FDA, EMA, MHRA, TGA and other ROW Regulatory agency guidelines is highly beneficial.

Essential Functions And Responsibilities

• Lead and provide scientific oversight of bioassays, safety assays, and bioanalytical studies including qualification, validation, verification and comparability of assays 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 CE (CGE and CZE), SDS-PAGE, icIEF, HPLC (SEC, RP, IEX, and HIC), FTIR, Protein Content by A280 and Lowry, ELISA (Host Cell Protein etc.), PCR based methods (Host Cell DNA etc.), Cell-Based Potency assays and basic compendial testing for pH, osmolality, subvisible particulate matter
• Subject matter expertise in interpretation of results for product characterization and elucidation of protein secondary and tertiary structure and post translation modification including but not limited to Glycan Analysis, Peptide Mapping, Circular Dichroism, Electrospray Ionization (ESI)-Q-TOF-MS, Amino Acid Analysis (MS/MS), Microflow imaging, Dynamic Light Scattering.
• Expertise in safety assay testing for product release and raw material qualification including but not limited bioburden, sterility and mycoplasma or bacteriophage. Experience with endotoxin testing particularly supporting low endotoxin recovery investigations is highly beneficial.
• Expertise in generating analytical methods validation master plans is highly beneficial.
• 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 and MCB/WCB qualification and release testing.
• Author and review SOPs, protocols, and associated reports, quality documents 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 – 25% of the time

Required Education, Skills, And Knowledge

• PhD with 3 years of industry experience, MS 6 years industry experience or BS with 8 years of industry experience in Protein Therapeutics with a focus in Biochemistry /Immunology /Molecular Biology field.
• Possess a solid understanding of verification and validation of assays supporting commercial and clinical 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 protein therapeutics (using microbial or Mammalian cell lines). Understanding of regulations and guideline documents (cGMP / ICH / USP / EP pharmacopeia) required.
• Ability to apply critical thinking skills to evaluate 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 fast-paced, collaborative environment and manage multiple concurrent projects 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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