QC Associate Director or Senior Scientist 1 or 2 - United States
- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain our company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
- Our company is seeking an Associate Director or Senior Scientist 1/2 , 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 lead transfer, some development, optimization and validation of QC tests 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.
- 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.
- Expertise in aseptic growth/manipulation of human, animal, and/or insect cell lines
- 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.
- Background in virology or molecular biology strongly preferred including sterile technique
- 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 GX.
- PhD in a scientific discipline with at least 8 years 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).
Reports to Quality Control Assay Support Director. Interacts with several departments, including but not limited to Manufacturing, Regulatory, Quality Assurance, Maintenance, Engineering, and Process Development.
1-2 direct reports; manage a group of 7-10 people.