BioMarin is seeking an Associate Director or Director, Gene Therapy Quality Control. The candidate is expected to direct and guide a new QC group which supports release, stability and in process testing of gene therapy products. In addition, the candidate will oversee the transfer, development, optimization, and validation of QC test methods, especially in areas of virology and molecular biology.
As the primary spokesperson for the group, this individual will be responsible for coordination with their counterparts throughout the QC department and various functional experts such as Regulatory Affairs, Process Development, Manufacturing, Quality Assurance, and Project Management, especially as they relate to gene therapy projects.
The successful candidate will have a strong analytical background, ideally with experience in biopharmaceutical quality control, and virology/molecular biology. Essential to this role is method validation knowledge and the ability to lead and mentor scientific and technical staff.
This position offers significant opportunity to develop scientific and managerial skills in a biotechnology environment. The selected candidate will work in a creative, fast-paced environment, interacting with scientists or individuals from diverse backgrounds.
The candidate will be required to manage scientific development, implement and maintain plans and strategies to support manufacturing, provide scientific expertise, prepare reports and keep upper-level management informed of progress and problems.
We are looking for a team player with a record of contribution to process optimization/validation, excellent interpersonal skills, and experience in managing and mentoring analysts.
It is especially important that there is both willingness and ability to ensure group-wide compliance with current regulatory requirements (cGMP) for testing of manufactured pharmaceutical products and intermediates. This role directly handles and/or is in proximity to lentiviral or other viral vector based gene delivery systems.
Oversee release and stability of gene therapy products
Oversee method validations (including authoring protocols and reports)
Optimize and validate viral infectivity and potency assays
Perform and appropriately document studies under cGMP to support in process, release and stability testing of clinical and eventually commercial gene therapy viral vector substance/product
Prepare technical reports and summaries
Prepare final reports, study plans, etc., as necessary for multiple projects
Prepare and deliver presentations of experimental results in internal forums
Contribute to project progress within his/her scientific discipline
Contribute to/author regulatory submissions and scientific journal articles
Train department staff on testing and laboratory systems
Biochemistry test method validation for in-process, release and stability
Experience in designing and executing large projects/studies.
Management experience/ability with laboratory associates or other scientific personnel
High level of initiative, independence, and ability to work under short time lines with limited day to day supervision.
Experience in techniques for titer (eg TCID50, qPCR, expression) of conventional, attenuated, and recombinant viruses as well as purity assessments for e.g. empty particles, foreign DNA, protein, etc.
Familiarity with use of a computer (e.g., Proficient in Windows, Microsoft Word, Excel, and statistical software (such as GraphPad or Minitab).
Familiarity with a range of analytical technologies such as HPLC, ELISA.
Good written and verbal skills.
Strong critical thinking/problem solving skills.
Proficien in the use of analytical software such as LIMS, Empower, ChemStation, and/or Softmax Pro.
Experience with or knowledge of Quality Control or GXP.
PhD in a scientific discipline with at least 8years of relevant laboratory/industry experience.
MS in a scientific discipline with at least 10 years of relevant laboratory/industry experience.
BS in a scientific discipline with at least 10 years of relevant industry experience.
Familiarity with a range of laboratory instruments is preferred (such as qPCR, cell counter, microscope, particle sizing, 96 well plate readers, HPLC, Spectrophotometer).