Associate Director, Quality Control/Technology

Employer
Tocagen
Location
San Diego, CA, United States
Posted
Jul 17, 2019
Ref
oBlD9fws
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Every member of our team plays a significant role in our success. Tocagen hires individuals who share our passion for ending cancer mortality and have exceptional talent that will contribute to this goal.

Associate Director Quality Control/Technology

Function/Scope:

The Associate Director will lead Tocagen's Quality Control (QC) department and manage all outsourced GMP testing. He/she will mentor QC personnel providing on-going training in analytical/bioanalytical method development, validation, and testing as well as techniques in trouble-shooting of assays and equipment. The Associate Director will ultimately responsible for coordinating all external GMP testing performed by suppliers, review and approve product release specifications, stability protocols and all testing whether performed by suppliers or in-house QC.

Duties and responsibilities include but are not limited to:

  • Lead the Quality Control department by bringing late stage product development/GMP testing and commercialization experience of small molecule solid oral and biologic dosage forms.
  • Identify and address technical and validation gaps in analytical methods and QC testing to ensure compliance with ICH Q2(R1), ICH Q5C, ICH Q5E, ICH Q6A, ICH Q6B, and WHO Annex 10.
  • Comprehensive working knowledge with Good Manufacturing Practices specific to 21 CFR 210/211, re-test and shelf-life expiry dating (ICH Q1E, WHO Annex 10), and proven experience and ability to implement compliance with these regulations for Tocagen's in-house QC laboratories and ensure compliance in these areas with GMP analytical suppliers.
  • Proven track record of designing and implementing data integrity requirements (WHO Annex 5, FDA's Data Integrity Guidance) in GMP laboratories. Specific experience ensuring the data integrity of legacy/hybrid equipment.
  • Work collaboratively with manufacturing, supply chain, quality assurance, regulatory, and project management to ensure timely availability of lot release, stability and other required analytical data.
  • Provide Quality Control support for regulatory submissions including but not limited to INDs, NDAs, BLAs, and IMPDs by furnishing required quality control data.
  • Responsible for maintaining continuous audit readiness of the Quality Control laboratory, including but not limited to, logbooks, equipment, software 21 CFR Part 11 compliance, data reporting, LIMS database,etc.
  • Direct experience authoring and implementing root cause analysis techniques (to the QC laboratory.
  • Collaborate with Quality Assurance as an analytical/QC subject matter expert in support of supplier audits.
  • Provide strategic planning, employee head-count and equipment projections
  • Perform or coordinate the periodic review of SOPs for the QC department.
  • He/she is responsible for setting of employee goals, ensuring that employees track to goals throughout the year, and authoring/performing annual employee performance reviews.
  • Proven success in training others in the compliance with ICH, FDA, and WHO guidances.
  • Other duties as assigned by supervisor.


Desired knowledge and abilities:
  • Eight (8)+ years of hands-on experience developing and validating bioassays, trouble shooting assay problems, and performing qPCR, HPLC and ELISAs in a GMP environment. Extensive experience with retroviral replicating vectors, aseptic technique, media preparation, and characterization of mammalian cell lines.
  • Six (6)+ years of solid oral dosage form experience developing, validating, and performing and trouble-shooting HPLC and UPLC methods for assay and impurities, content uniformity, dissolution, disintegration, water content (Karl Fischer) and microbial limits testing in a GMP environment.


Education and Experience:
  • BS in Biology, Microbiology, Chemistry, or a related pharmaceutical science (e.g. Pharmacy). An advanced degree a plus.
  • Proven staff leadership abilities in developing staff and functional integration into multi-disciplinary project teams
  • A minimum of 12+ years of progressive managerial experience within the Quality Control function of a pharmaceutical company. A minimum of 7 years supervisory experience leading a Quality Control function is preferred.
  • Experience working in small biopharmaceutical company and/or experience working within a virtual manufacturing company utilizing a number of contract manufacturing organizations is preferred
  • Experience with biologics development programs, as well as small molecule biologics from early-stage through commercial. Experience with parenteral products is preferred.
  • A strong team player is required with the ability to effectively communicate sound Quality advice cross-functionally based on experience, regulations & business needs
  • Experience with using risk-based principles, industry practices, and decision making to ensure compliance at all stages of development
  • Proven track-record of leadership & building relationships with both internal & external customers
  • Strong negotiation skills, flexibility & ability to provide a solution-based approach to emerging challenges.
  • Excellent communication skills and abilities to collaborate with and present to individuals of varying levels of authority, including senior and Executive leadership
  • Strong analytical, problem-solving, and critical thinking skills
  • Excellent writing and skills with Microsoft Word, Excel, Power Point, and Project
  • Experience managing complex outsourcing manufacturing relationships.
  • Interpersonal skills; good judgment and ethics; professional presence and demeanor
  • Strong business orientation and financial skills
  • Excellent verbal and written communication skills; strong presentation skills as this role requires the ability to communicate and connect with all levels of the organization