Associate Scientist

Aditi Consulting • Contract • Thousand Oaks, CA, US • $24 - $25 / hour • 1w ago

Payrate: $24.00- $25.00/hr.

Summary:
As a member of the process development team, this role will be focused on identifying and developing aspects of drug products to advance process design for parenteral drug products. The candidate will perform experiments, organize data and analyze results with minimal supervision. The candidate will establish experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups.

Responsibilities:

Design, execute and document primary data packages related to drug product design and process development, and communicate key findings in presentations
Develop solutions to technical problems during process characterization and aseptic manufacturing
Support one or more clinical and commercial process introductions or process transfers into manufacturing network
Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
Provide ongoing support to clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships

Requirements:

BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology with 3+ years of experience within the pharmaceutical/biotechnology industry
MS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology
Experience in development/characterization of aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, stoppering, visual inspection, etc.) to define critical process parameters
Aseptic fill finish manufacturing or manufacturing technical services experience including the development of control strategies and active process performance monitoring
Understanding process related stresses that impact the quality and stability of biologics
Ability to use engineering principles to leverage bench and pilot scale models for process performance characterization
Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools (e.g. Fish bone diagrams, FMEA, etc.)
Familiarity with Design of Experiments (DOE) and Quality by Design (QbD) principles
Familiarity with cGMPs, regulatory filings, and compliance issues for sterile injectable products manufactured by aseptic processing
Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
Organizational, technical problem solving, communication (written and verbal) skills, and regular interactions
Ability to learn and act on dynamic information at a rapid pace
Familiar or ability to learn to use electronic record keeping, GMP, laboratory notebooks, statistical analysis and software.
Laboratory or pilot plant experience with process equipment

Must Have Skills:

Aseptic fill finish manufacturing or manufacturing technical services experience including the development of control strategies and active process performance monitoring
Ability to use scientific principles to leverage bench and pilot scale models for process performance characterization
Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools (e.g. Fish bone diagrams, FMEA, etc.)
Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
Nice to have: Leverage advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling, to drive innovation and accelerate research, development, and testing processes.
Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.

Pay Transparency: The typical base pay for this role across the U.S. is: $24.00- $25.00/hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, denmatch, lifeion benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.

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