Director, QC & Analytical Development

Job Level:                  Director

Job Title:                   Director, QC & Analytical Development

Department:             Quality Control

Reports To:              Vice President of Operations

Develops, implements, and maintains the activities of quality control systems.  Oversees the development of standards, methods and procedures for the biochemical, microbiological, and physical testing of components, raw materials, excipients and final vaccine product.  This position will work in close collaboration with Manufacturing, Operations, Quality Assurance and Clinical Operations to determine product-specific critical quality attributes leading to mission critical product characterization and potency assay development for autologous cellular immunotherapy vaccine(s) in support of early and late stage clinical development programs.

 Duties & Responsibilities

Other duties may be assigned

  • Execute management responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Select, train, motivate and develop a highly technical staff with experience in a wide variety of disciplines to accomplish both the department’s and the site’s objectives. Responsible for the overall direction, coordination and evaluation of the reporting departments and functions.
  • Provide function specific subject matter expertise for the site during any regulatory agency inspection and ensure timely responses to any issues which may be identified.
  • Set strategy and oversee de-novo biological assay development from proof of concept to qualified assay for cell-based functional assays and immunoassays to characterize plasmid transfection efficiency, product potency, stability, cytokine production or knock down with emphasis on automation.
  • Oversee the development, qualification and validation of analytical and microbiological test methods to support Product Release, Plasmid & Product Stability, Environmental Monitoring and Sterility Assurance Programs in accordance with ICH, industry guidance or emerging industry trends.
  • Develop sound scientific strategy to support regulatory acceptance of biological assays in clinical development and draft analytical and stability sections for regulatory filings.
  • Develop and execute phase specific biological characterization strategy for autologous cellular immunotherapy vaccine. Direct optimization, validation and transfer of validated methods to/from commercial quality contract testing laboratories.
  • Establish a robust and compliant stability program for autologous cellular immunotherapy vaccine.
  • Establish specifications and testing process of raw materials. Develop in-process and final specifications for plasmids and autologous cellular immunotherapy vaccine.
  • Lead internal and external QC testing, including biochemical, gene sequencing, ELISA, Western Blot, PCR, bioassays, cell-based assays, cell counts, cell viability, gram stain, endotoxin, mycoplasma, and sterility.
  • Track, trend, and report data for Management Reviews and Annual CMC updates for quality systems associated with QC department.
  • Oversee the department’s GMP sample management for raw materials, in-process, release and stability testing, performed either in house or at CTO ensuring chain of identify and chain of custody.
  • Direct technical troubleshooting and/or Laboratory investigations for deviations or out-of-specification results.
  • Set up new or expand QC Laboratories ensuring that equipment is appropriately qualified or validated.
  • Direct the development and/or technology transfer or use of analytical test methods used for product release, product characterization, process validation and/or product investigations.
  • Establish microbial limits and/or environmental monitoring program for raw materials, facilities, gowning certification, and cleaning verification.
  • Establish goals and objectives for Quality Control department that are consistent with site’s Operations Objectives and Corporate Quality Objectives. Translate goals and objectives into personnel performance objectives.
  • Develop and execute the budget plan required to meet production goals, and assure costs are maintained within constraints of budget. Assist in development and implementation of capital budget to ensure facilities and equipment are sufficient to support plant and department goals and objectives.
  • Develop or review training programs to assure their adequacy, repeatability, effectiveness, as applicable.
  • Drive continuous improvements efforts for products and quality systems.
  • Support Regulatory Submissions by providing documentation and summary reports as required.

Minimum Requirements

  • Bachelor’s degree in relative scientific discipline required, Ph.D. is preferred in immunology, cell biology, molecular biology, or equivalent field.
  • 10 (+) years of progressive quality, scientific, or manufacturing experience  in a leadership  position within the pharmaceutical or biologics operations; biologics or vaccines experience preferred.
  • 5 (+) years of experience in a Quality Leadership role
  • Knowledge of all QC/QA activities and regulatory requirements in the pharmaceutical/medical device industry, preferably involving cell therapies/injectable drugs
  • Strong history of rigorous science applied to drive technical accomplishments.
  • Experience in planning and implementing analytical and CMC strategy for the development of large molecule biologics or gene therapy.
  • Well versed in various analytical techniques such as FACS, ELISAs, PCR, UV and Fluorescence spectroscopy, Western Blot, ELISPOT and other applicable methods to the testing of biopharmaceuticals.
  • Excellent understanding of mechanism-of-action for cellular therapies.
  • Leadership – must exercise leadership and move others to action; this includes peers and superiors, as well as subordinates. He/she needs to demonstrate a positive, results-oriented style by planning, motivating, organizing and controlling the work being done;
  • Promotion – He/she should have the capacity to grow and take on additional responsibilities;
  • Interpersonal Skills – Able to foster excellent relationships and credibility quickly at all levels of the organization, as well as the ability to create a partnership atmosphere with internal and external resources while achieving key operating objectives;
  • Business Acumen/Competitive Knowledge – He/She needs to maximize opportunities and advantages and search for ways to leverage the current position;
  • Integrity – A professional of unquestionable integrity, credibility and character who has demonstrated high moral and ethical behavior;
  • Communication – Ability to develop and articulate an effective flow of ideas and information that generates an understanding and creates a climate in which others are informed and want to participate;
  • Planning and Analysis Skills– He/She must have the ability to analyze and grasp an entire situation quickly from many perspectives and to create well-reasoned solutions. He/she needs to be conceptual, able to recognize problems from few or subtle clues and be innately comfortable with complexity. He/she should be able to demonstrate a probing, analytical approach;
  • Training/Coaching Skills – Able to foster the professional development of subordinates through coaching/feedback on results, willing and able to share personal knowledge/experience and able to move decisively with performance problems;
  • Maturity – Ability to be aggressive and confident, thus providing a good balance of risk taking and judgment.
  • Function as a Management Representative.

Travel Requirements

10-15% travel outside the DFW metroplex

Physical Demands

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 30 pounds is required.

 Work Environment

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
  • The noise level in the work environment is quiet to moderate.

 Please send your resume to email employment@gradalisinc.

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