Associate Director, Analytical Development

Department
Technical Development

Location
San Diego, CA

Summary Description
The Associate Director, Analytical Development will lead the analytical development and testing efforts of multiple projects and will be responsible for guiding a productive analytics program. The responsibilities of the Analytical Development include bioanalytical physio-chemical and biosafety assay development, qualification/validation as well as routine testing to support process development, release and stability programs, requiring both internal and external GMP and non-GMP efforts. The incumbent will lead a team of professional scientists and efficiently manage scientific efforts and resources to ensure the attainment of company objectives in a timely manner. The Associate Director must be able to effectively communicate results and issues within the projects to management and customers (internal and external) with the highest of professional standards.

Specific Responsibilities:

  • Provide leadership and management within the department through a process of goals and expectations setting, performance appraisal, mentoring and individual development
  • Provide strategic CMC and scientific solutions to the vaccine development projects. Liaise with all members of CMC teams and work closely to identify CQAs and develop robust Specifications
  • Lead a group of scientists for multiple vaccine development projects.  By improving individual performance and group collaboration, the Associate Director will ensure high overall productivity and efficiency of the department
  • Carry out an active laboratory analytical program, identifying, characterizing and quantifying lead vaccine candidates including identification, development and validation of procedures and/or equipment as necessary, and be able to solve the more complex analytical problems that arise
  • Provide guidance in initiation and closure of deviations, CAPA, change control
  • Evaluate trend data and author trend reports for life cycle of the vaccine and proactively identify and resolve issues
  • Ensure that the analytical development functions are completed in accordance with the Company and regulatory agency standards of safety and quality and that all experimental documentation is complete and timely
  • Allocate the department’s resources according to project priorities set by management
  • Resolve any issues and provide possible solutions through interaction with other departments and management, especially as it relates to the improvement of technical capability, morale and productivity of the department’s scientists

Requirements:

  • BS/MS with a minimum of 15 years or PhD with a minimum 8-10 years of industry experience in large molecules
  • Experience in analytics of biologic drug characterization and testing from early through late development stages
  • Extensive knowledge and working experience in drug product development
  • A minimum of  5 years in a management role in a GMP pharmaceutical environment with demonstrated mentorship experience
  • Good understanding of regulatory requirements: EMA, FDA, ICH, USP/EP/JP
  • Ability to work independently and manage projects in a timely manner
  • Ability to effectively document and communicate results
  • Strong interpersonal skills with an eagerness to support colleagues in AD and CMC teams
  • Strong leadership experience

Preferred Qualifications:

  • Experience working with both early and late phase drug development programs
  • Experience working in Project teams
  • Experience managing CMOs and CROs

Competencies:

  • Goal oriented
  • Team leadership and teamwork
  • Customer focus
  • Innovative/creative
  • Attention to detail
  • Highly organized
  • Adaptability to change
  • Problem solving
  • Outstanding written and verbal communication skills
  • Excellent documentation skills
  • Ability to execute in a fast pace environment
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