Manager, Analytical Development - Protein Sciences

March 19

🔔 Pennsylvania – Remote

Although this job is listed in Pennsylvania, this company may be open to hiring remote in other states.

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Iovance Biotherapeutics, Inc.

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Iovance Biotherapeutics, Inc. is pioneering a transformational approach to treating cancer by harnessing the human immune system's ability to recognize and attack diverse cancer cells in each patient. The company focuses on T-cell-based immunotherapy, specifically Tumor Infiltrating Lymphocyte (TIL) therapy, which involves reinvigorating a patient’s TILs to fight cancer. Iovance's TIL therapy is being investigated in clinical trials across multiple advanced solid tumor cancers. Additionally, the company is advancing genetically modified TIL therapies and exploring potential applications of PBL (peripheral blood lymphocyte) therapy for blood cancers. As a leader in cell therapy, Iovance owns a state-of-the-art Cell Therapy Center in Philadelphia for manufacturing their therapies using proprietary GMP. The company is at the forefront of developing personalized and patient-specific cancer treatments.

Immuno Oncology • Autologous Cell Therapy • Tumor Infiltrating Lymphocytes (TIL) • Novel Cancer Immunotherapies • cell therapy

501 - 1000 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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.

🎯 Requirements

• 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.