Process Development Engineer/Purification

4 weeks ago

Thousand Oaks, United States ACL Digital Full time

Job Title: Process Engineer

Location: Thousand Oaks, CA

Duration:12 Months


Description:

ONSITE AT USTO


Currently seeing more documentation side and need to see hands on engineer experience with proper training/ background in technical side/ mathematics. NOT LOOKING for quality lab/ bench top/ science work.


As a member of the process development team, this role will be focused on identifying and developing aspects of drug product 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 the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups.

Specific responsibilities include but are not limited to:

• 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 Amgen 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


Preferred Qualifications

• MS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology

• 3+ years of experience within the pharmaceutical/biotechnology industry

• 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 of 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


Basic Qualifications

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience


Top 3 Must Have Skill Sets:

Looking for direct transferable experience in drug product manufacturing

Strong academic background or commercial GMP experience

Ability to work in fast pace environment

Lab or pilot plant experience


Ideal candidate has solid manufacturing experience coming into the role (specifically being the ?end user? in the manufacturing spectrum is great but not required)

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