Manager, QC Assay Support - United States
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- 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 a QC Manager within the QC Assay Support group.
- The candidate will lead transfer, development, optimization and validation of QC assays in the area of virology and molecular biology for our gene therapy products.
- The successful candidate will have a strong background in virology and/or molecular biology.
- The candidate will play a key role in developing, optimizing, and validating QC test methods related to gene therapy.
- Essential to this role is a strong knowledge base and broad expertise in classical and molecular virology and the ability to lead and mentor scientific staff and collaborate with cross functional team members to execute product development.
- 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, provides scientific expertise, prepare reports and keeps 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.
- Initiate and execute experiments, either independently or as a team member
- Bank, initiate, grow, and maintain various cultured cells
- Develop and optimize viral cell culture systems
- 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, summaries, validation protocols, and validation reports
- Prepare final reports, study plans, etc., necessary for multiple projects
- Prepare and deliver presentations of experimental results in internal forums
- Contribute to project progress within his/her scientific discipline
- Perform as subject matter expert on virology and molecular biology tests in quality control
- Contribute to/author regulatory submissions and scientific journal articles
- Train department staff on testing and laboratory systems SOPs
- 4-6 years in GMP work setting
- 1-2 years of experience with assay validations
- Expert in growth of multiple human, animal, and 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
- Expert in rt/quantitative PCR
- 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 wide range of analytical technologies such as HPLC, ELISA, plaque/TCID50 and/or cell expression assays.
- Good written and verbal skills.
- Strong critical thinking/problem solving skills.
- Proficient in the use of analytical software such as LIMS, Empower, ChemStation, and/or Softmax Pro.
- Experience in designing and executing large projects/studies is essential.
- Experience with or knowledge of Quality Control or GXP is desirable.
- Management experience/ability with laboratory associates or other scientific personel
- High level of initiative, independence, and ability to work unsupervised.
- PhD in a scientific discipline with at least 0-2 years of relevant laboratory experience.
- MS in a scientific discipline with at least 5-6 years of relevant laboratory experience.
- BS in a scientific discipline with at least 8 years of relevant laboratory experience.
Familiarity with a range of laboratory instruments is preferred (such as qPCR, cell counter, microscope, particle sizing, 96 well plate readers, washers, 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.