Manager, Analytical Development - Remote

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.

In Short

• Lead and provide scientific oversight of bioassays, safety assays, and bioanalytical studies.
• Subject matter expertise in developing and performing analytical methods.
• Expertise in safety assay testing for product release and raw material qualification.
• Lead study design for analytical runs and investigations.
• Provide project management oversight of external contracts.
• Author and review SOPs, protocols, and associated reports.
• Maintain a high level of professional expertise through regular consulting of scientific literature.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties assigned.
• Travel – 25% of the time.

Requirements

• PhD with 3+ years of industry experience, MS + 6 years industry experience or BS with 8+ years of industry experience in Protein Therapeutics.
• Solid understanding of verification and validation of assays.
• Quality control and GMP experience is required.
• Prior experience developing and supporting protein therapeutics.
• Ability to apply critical thinking skills to evaluate requirements.
• Prior experience with project management tools.
• Must be capable of working in fast-paced, collaborative environment.
• Strong interpersonal, written, and oral communication skills are required.
• Must be organized, able to multi-task, and be a team player.

Benefits

• Opportunity to work in a diverse and inclusive environment.
• Engagement in innovative projects related to cancer treatment.
• Professional development opportunities.
• Collaborative work culture.
• Flexible work arrangements.