Director of Analytical Development - Job # 3019

Additional Information
  • Our Client offers an exceptional compensation package which will be commensurate on experience and great benefits and a growth opportunity.
  • For confidential consideration please submit a resume and salary history to claire@fullscalesolutions.com.
  • Please be sure to include the job number with your submission.
  • Full Scale Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Client Synopsis:

Full Scale Solutions is currently recruiting for the following position located in Raleigh-Durham, NC.

We are seeking to hire a Director of Analytical Development who will be responsible for developing analytical processes that support gene therapy products in clinical development and commercial products. Directing methods development, testing, and evaluation. Handling, and collaborating with others on, analytical chemistry issues. Developing and directing testing methodologies to control raw materials, production intermediates, and finished products. Directing assay development, qualification/validation, and supporting QC testing for preclinical and clinical studies.

Duties and responsibilities include, but are not limited to:

  • Directs the development, qualification, and validation of analytical test methods and technology transfer, in accordance with ICH and company guidelines.
  • Performs method validation protocol and creates reports, establishing specifications for products.
  • Provides significant support to the product development team in formulation.
  • Takes a leading role in setting strategic analytical initiatives. Sets strategy for evaluating and implementing new technologies. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
  • Effectively facilitates cross-functional and interdepartmental initiatives to best meet the needs of projects.
  • Establishes goals, structures experiments, analyzes data, and recommends and plans actions to achieve project objectives. Monitors and evaluates completion of tasks and projects.
  • Adapts and designs analytical models based on the CQAs, process control strategies, and emerging industry trends. Integrates and maximizes the contribution of science and technologies to the development process.
  • Assists in GMP investigations, including deviation root cause analyses, CAPA, and out-of-specification.
  • Works on complex problems in which analysis of situations or data require an in-depth evaluation of various factors.
  • Supports process development, specification setting, and CMC regulatory filings and responses. Authors or updates analytical parts of the drug product section of regulatory submissions.
  • Develops strategic operational plans and implements changes throughout the laboratory environment.
  • Establishes laboratory company policies and responsible for overall laboratory operations with focus on consistent implementation of policies, procedures, and business practices.
  • Motivates, trains, and monitors laboratory personnel by establishing and maintaining guidelines for standards of performance.
  • Follows all safety, GLP, and cGMP rules and regulations.
  • Fosters smooth functioning of analytical laboratory through timely and effective resolution of technical challenges.
  • Reviews Quality Control documentation.
  • Maintains a current knowledge of latest technological/scientific trends. Maintains a thorough working knowledge of, and champions the efficient execution of, cGMP, as related to analytical activities.
  • Reviews, and remains familiar with, current literature related to AAV vector production.
  • Provides scientific/technical guidance, leadership, and decision-making, as appropriate.
  • Assists with activities as needed, including scientific writing, writing SOPs, reviewing SOPs, and serving as a subject matter expert as needed.
  • Develop budgets for expenditures and labor.
  • Is the liaison with Manufacturing, Process Development, Regulatory, Quality Control, and Quality Assurance. and will have Regular contact with laboratory personnel and QC analysts and external vendors.
  • This position requires the ability to act independently and to take initiative with minimal supervision from manager.
  • Advise manager of work schedule, priorities, problems, and of planned and unplanned absences.

Requirements:

  • PhD in Biochemistry/Protein Chemistry, Chemical Engineering, or related disciplines with a minimum of 15 years of relevant experience in a pharmaceutical/biotech laboratory environment, manufacturing of cell or gene therapy products preferred; Experience in viral particle purification preferred.
  • 15 years of experience with the various analytical techniques and services essential for the overall department productivity, including but not limited to stability studies, compatibility studies, method development and validation, Chromatography Data Systems, BMF review.
  • Experience with EMA/FDA regulations, ICH Q8 and Q9 guidelines, GMP, and Quality systems.
  • Possesses knowledge of AAV and complex strategies of purification including Cell lysis, Depth Filtration, Tangential Flow Filtration, and Chromatography (Affinity, Ion Exchange).
  • Knowledge of advanced statistical techniques, such as data trend analysis and design of experiments, is highly desirable.
  • Experience with BLA filings and regulatory agency interactions highly desirable.
  • Strong knowledge of GLP, safety, and related compliance regulations and guidance.
  • Experience working in a GMP testing environment with an understanding of regulatory requirements and trends related to analytics and product development.
  • Possesses strong interpersonal, teamwork, and collaboration skills. In addition, possesses strong workload planning skills, organization, attention to detail, and follow through.
  • Problem-solving, analytical, and trouble shooting skills are essential. Demonstrates strong technical and theoretical understanding of complex processes.
  • Must have excellent written and verbal communication skills, technical documentation skills, including the ability to effectively communicate to all levels of the organization.
  • Ability to prioritize and multi-task concurrent project demands. Strong computer skills in Microsoft Office required e.g. Word, Excel, and PowerPoint.

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