Senior Scientist, QC Analytical Technologies
Marin Metro Area, CA
We are seeking a Molecular Biology or Biochemistry Scientist within the QC Analytical Technologies group (Scientist 2 / Senior Scientist). The candidate will oversee special studies and manufacturing support for process optimization, process qualification, and deviation investigations. The scientist will potentially supervise up to five analysts. Activities include defining and executing scientific plans, tabulating and processing process and analytical data, and working with other scientists and team members. The Scientist 2 / Senior Scientist candidate will also assist with regulatory filings and serves as the QC representative for inter-departmental meetings.
The candidate will play a key role in product development and manufacture. Essential to this role is a strong knowledge base and broad expertise in biochemistry or molecular biology and the ability to lead and mentor scientific staff and collaborate with cross functional team members to execute product development. 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. Previous experience with potency and purity test methods for gene therapy or protein therapeutics and cell culture is highly desirable. The candidate must have five years of experience leading teams and five years of experience in a GMP environment.
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. 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. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
PhD in a scientific discipline with at least 5 years of relevant laboratory experience.
MS in a scientific discipline with at least 10 years of relevant laboratory experience.
BS in a scientific discipline with at least 14 years of relevant laboratory experience
Expert in growth of multiple human, animal, and insect cell lines is desirable.
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, and/or bioassays.
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 required.
High level of initiative, independence, and ability to work unsupervised.
Oversee assigned investigations and deviations
Serve as SME for QC test methods
Prepare technical reports, summaries, and presentations as needed.
Prepare study plans as necessary for multiple projects
Prepare and deliver presentations of experimental results and investigations in internal forums
Contribute to project progress within his/her scientific discipline
Contribute to/author regulatory submissions
Train department staff on testing and laboratory systems SOPs