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Associate Scientist

The Steely Group

Thousand Oaks, CA

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JOB DETAILS
SKILLS
Analysis Skills, Asepsis, Biochemistry, Biomedical Engineering, Biotech and Pharmaceutical, Chemical Engineering, Chemistry, Clinical Support, Communication Skills, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Detail Oriented, Documentation, Drug Design, Drug Products, Experiment Design, Failure Mode and Effects Analysis (FMEA), Identify Issues, Industry Standards, Investigational New Drug (IND), Maintain Compliance, Manufacturing, Manufacturing Requirements, Manufacturing/Industrial Processes, Marketing Software, Operational Improvement, Operational Strategy, Pilot Plant, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Process Improvement, Process Validation, Product Design, Record Keeping, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Risk Analysis, Root Cause Analysis, Statistics, Sterilization, Support Documentation, Team Player, United States Department of Energy (DOE), Writing Skills
LOCATION
Thousand Oaks, CA
POSTED
1 day ago

Our client is seeking a highly motivated and detail-oriented Associate Scientist to join the process development team in Thousand Oaks, CA. This role offers an exciting opportunity to contribute to the development and optimization of parenteral drug products, ensuring high-quality manufacturing processes that meet regulatory standards. The position involves hands-on experimental work, data analysis, and cross-functional collaboration to support clinical and commercial manufacturing. Candidates will have the chance to work in a collaborative environment that fosters professional growth, skill development, and impactful contributions to innovative pharmaceutical products.

Key Responsibilities:
  • Design, execute, and document primary data packages related to drug product design and process development, communicating key findings through presentations.
  • Perform experiments to optimize processes for aseptic fill/finish operations, including freeze/thaw, mixing, sterile filtration, filling, and visual inspection.
  • Develop solutions to technical challenges encountered during process characterization and aseptic manufacturing, supporting process transfers and improvements.
  • Support clinical and commercial process introductions by troubleshooting, root cause analysis, and product impact assessments for non-conformance issues.
  • Author and review technical protocols, reports, product impact assessments, and regulatory documentation in support of IND and marketing applications.
  • Collaborate effectively with cross-functional teams, including Analytical Sciences, Manufacturing, Regulatory, and Quality, to drive process improvements and operational efficiency.
  • Utilize engineering principles and risk assessment tools (e.g., FMEA, fishbone diagrams) to enhance process performance and scale-up efforts.
  • Maintain compliance with cGMPs, regulatory requirements, and industry standards, ensuring documentation accuracy and regulatory readiness.

Qualifications:
  • Bachelor’s degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry, or Biotechnology with 3+ years of industry experience, or Master’s degree in a related field.
  • Experience in aseptic fill/finish manufacturing, including process development, characterization, and scale-up.
  • Familiarity with Design of Experiments (DOE), Quality by Design (QbD), and process validation principles.
  • Knowledge of cGMP regulations, regulatory filings, and compliance related to sterile injectable products.
  • Strong problem-solving skills and experience working within a matrix team environment.
  • Excellent written and verbal communication skills.
  • Ability to learn and adapt quickly in a fast-paced environment, with proficiency in electronic record keeping and statistical analysis tools.
  • Laboratory or pilot plant experience with process equipment related to sterile manufacturing.

Work Location: Onsite - Thousand Oaks, California

About the Company

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The Steely Group

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