Associate Director in Palo Alto, CA at Apex Life Sciences

Date Posted: 7/15/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Palo Alto, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    7/15/2018
  • Job ID:
    858286

Job Description


 Apex Life Sciences is seeking an Associate Director of Quality Assurance to ensure quality and compliance of our lab with all Federal and State regulations governing the manufacturing of cell and gene therapy products for clinical trials conducted under Investigational New Drug (IND) applications and in a cGMP setting. The Associate Director will oversee the quality assurance activities related to manufacturing and release of clinical products at the lab; will ensure facilities and manufacturing operations are conducted according to current Good Manufacturing Practices (cGMP); will provide strategic direction for policies and procedures that govern quality and compliance within the lab for all clinical therapeutics manufacturing at the lab; will provide final quality assurance for product release to clinic. The Associate Director will be part of the lab management team and will act as a liaison between the lab and clinical and research investigators, other collaborators and vendors.

Duties include:

  • Provide strategy and vision; make decisions that establish objectives for the overall direction or operation of a significant project(s) or area(s).
  • Manage staff of a large science, engineering, and/or technical research area, which includes recruiting, hiring, developing, evaluating and setting priorities; manage business, technical, and educational activities for direct reports including managers and technical experts.
  • Identify, clarify, and resolve issues with strategic impact and substantial significance, which spam multiple areas, using advanced technical and professional knowledge requiring broad discretion and judgment.
  • Collaborate with others on the direction of activities relevant to long-term objectives. Develop strategies to ensure effective achievement of objectives.
  • Develop policies and procedures as they relate to academic or program activities.
  • Implement, evaluate and maintain quality control standards to ensure program success.
  • Establish, oversee and manage financials and schedule for large programs and/or multiple projects.
  • Recommend the adoption of emerging technologies and the development of new methods and approaches.
  • Negotiate with internal departments and external agencies with authority to commit resources and effort.
  • Serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.

Desired Qualifications:

  • Advanced experience applying multidisciplinary scientific principles and practices to provide technical leadership and influence experimental design and coordinate laboratory activity
  • Extensive experience with Quality Assurance systems and processes.
  • Expert knowledge and technical understanding of the manufacture of Cellular Therapeutics and testing.
  • Extensive experience in reviewing cGMP/GLP related documents (SOPs, protocols, batch records, technical reports, etc.)
  • Full knowledge of GMP/ ISO compliance and quality systems.
  • Strategic planning, leadership, and negotiation skills, and the ability to develop and present training materials to large groups

Education & Experience (Required)

Bachelor's degree and eight years of relevant experience or combination of education and relevant experience. Advanced degree may be required.

Knowledge, Skills and Abilities (Required):

  • Experience leading, managing, motivating and developing technical staff.
  • Experience leading complex scientific, engineering or technical research projects or programs.
  • Detailed understanding of relevant business and technical knowledge and problem resolution.
  • Ability to synthesize and articulate technical and scientific methodologies, specifications, and information.
  • Knowledge of emerging technologies, trends, methodologies, and resource management principles.
  • Demonstrated ability to work and communicate effectively with others.
  • Exceptional customer relationship and consensus building skills.
  • Ability to influence and establish effective working relationships in a diverse environment.
  • Ability to resolve complex issues quickly and make decisions that meet university objectives in a collaborative culture.

If you feel you would be a good fit for this position, please email your resume to jwegnes@apexlifesciences.com

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.