Senior MSAT Scientist III

2 weeks ago

Houston, Texas, United States Planet Pharma Full time
Job Title: Senior MSAT Scientist III

We are seeking a highly skilled Senior MSAT Scientist III to join our Manufacturing Science and Technology (MSAT) Team at Planet Pharma. This role is pivotal in transferring viral vector bioprocesses into GMP production, collaborating closely with clients and cross-functional internal teams.

Key Responsibilities:
  • Leverage process flow diagrams and acquired expertise to facilitate detailed manufacturing processes under the guidance of senior MSAT scientists or managers.
  • Manage the technology transfer for all aspects of buffer and media production, cell thawing and culturing, harvesting, purification, and bulk filling of drug substances.
  • Conduct process transfers from us or clients, ensuring compliance with GMP conditions and employing project management skills to meet timelines and address risks proactively.
  • Support new product introductions (NPI) and technology transfers with minimal oversight, identifying and correcting errors from prior runs while supervising operations to ensure adherence to planned manufacturing processes.
  • Develop expertise in various unit operations and process analysis techniques, striving for holistic solutions to complex quality system deviations to ensure high process and product quality.
  • Participate in technology transfer, oversight, and process improvements for all process steps, operating with reduced supervision from senior MSAT scientists.
  • Assist in creating comprehensive bills of materials and performing materials suitability assessments, collaborating with junior engineers.
Qualifications:
  • Bachelor's degree in a science-related field (MS or PhD preferred).
  • 5-10 years of relevant experience, particularly in GMP manufacturing support (viral vector or cell and gene therapy preferred; microbial or mammalian processing experience required if lacking a VV/CGT background).
  • Strong understanding of current Good Manufacturing Practices and US/EU regulations.
  • Advanced knowledge of cellular biology, cell culture, scale-up processes, bioreactor operation, depth filtration, tangential flow filtration, chromatography, viral filtration, buffer/media production, and aseptic processing.
  • Proven critical thinking and problem-solving skills, with the ability to articulate technical issues and solutions clearly to technical audiences, both verbally and in writing.
  • Experience leading small projects independently and collaborating cross-functionally to achieve objectives.
  • Proficient in basic and advanced root cause analysis techniques (e.g., Five Whys, Kepner-Tregoe, Fishbone diagrams, Pareto analysis, DMAIC).
  • Skilled in basic risk identification and remediation, leading assessments using methodologies like FMA, FMEA, HAZOP, or HACCP.
  • Detail-oriented with a high degree of accuracy.
  • Familiarity with statistical data analysis is a plus.
  • Strong communication, technical writing, organizational, and interpersonal skills, capable of guiding junior scientists on smaller issues and challenges.

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