Associate Director, Biologics Analytical Development
Posted on Apr 5, 2021 by Nektar Therapeutics
Associate Director, Biologics Analytical Development, part of Nektar Biologics CMC organization, is responsible for directing and developing the team responsible for product characterization, analytical method development/qualification and IND/BLA document preparation for Nektar Biologic products in pre-clinical and clinical development stages. Conducts and collaborates with others on analytical issues relevant to long-term objectives and concerns. Develops and directs testing methodologies to control raw materials, production intermediates, Drug Substance and finished Drug Products. Develops strategies to ensure effective achievement of scientific objectives. This job contributes to and supports the companys research and development efforts to create high value therapeutics to address unmet medical needs.
Essential Duties and Responsibilities
Scientific oversight of analytical development for recombinant DNA-derived biologics products (process intermediates, protein intermediate, PEGylated drug substance and drug product), including activities performed internally and at contract facilities:
Analytical method development, optimization, transfer, and qualification
Will create and own the strategic plans regarding the development and implementation of methods, techniques, and evaluation criteria. Maintains a current knowledge of state-of-the-art technological, scientific and regulatory trends.
Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives as well as an understanding of the business. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans and performance requirements. Directs project workloads to provide innovative technical solutions to meet project deadlines. Develops, supports and maintains development report writing systems, development reports, documents and data storage. Prepares sections of IND/BLA submissions when required. Ensures budgets, schedules and performance requirements are met. Assesses utilization of resources and identifies when, and where additional resources may be needed. Ensures staff members are appropriately trained and training records are maintained at current required levels. Regularly interacts with senior management. Helps to ensure the effective application of process technologies across partner projects. Establishes goals, structures experiments, analyzes and reduces data, recommends and plans actions to achieve project objectives. Works in conjunction with functional teams to transfer and implement science/technology. Communicates cross-functionally with groups such as formulation development, manufacturing and other groups to ensure appropriate project support. Maintains a current knowledge of latest technological/scientific trends. Hires and trains staff at appropriate levels of need, coordinates annual reviews, and counsels junior staff on career related subjects. Provides scientific/technical guidance, leadership and decision-making as appropriate. Provides regular performance feedback, development and coaching to direct reports. Maintains a thorough working knowledge of and champions the efficient execution of cGMP, as related to analytical activities in the pharmaceutical industry. Provides regular performance feedback, development and coaching to direct reports.
Minimum Qualification Requirements
A minimum of a Bachelors degree in a scientific or engineering discipline is required. An advanced degree is preferred. Equivalent experience may be accepted. A minimum of 10 years experience in the pharmaceutical or other related industry is required. A minimum of 8 years previous biotechnology/pharmaceutical industry experience, preferably in a process development FDA regulated environment, is required. Expertise in state of the art analytical characterization tools, such as, MS, HPLC, CE, spectroscopy and allied techniques to elucidate protein structure and function is required. Previous experience with structural characterization of complex proteins and protein conjugates highly desirable. Good track record in advancing Biologics drug candidates in clinical development and Regulatory agency (FDA, EMA) interaction required. Prior experience with technology transfer and providing oversight to contract manufacturing organizations (CMO) desirable. Excellent written and verbal communications and teamwork skills are essential. Must have experience within biologics CMC that includes pilot plant, scale up and commercial manufacturing support. Must have experience in technology transfer from development into a pharmaceutical production operation. Strong verbal and written communication skills are required. Must be goal-oriented, quality-conscientious, and customer-focused. Good compliance and safety practices are a must. Must be experienced in working in a team-focused environment. A proven track record in developing and managing process development organizations is a must. Must have a thorough working knowledge of FDA and cGMP requirements for areas of responsibilities. Project management experience is a plus. A proven ability to work within a budget and timeline and provide cost savings is required.