Process Engineer Senior, Drug Product Tech Transfer; JP

Position: Process Engineer Senior, Drug Product Tech Transfer (JP13213)
Job Title:Process Engineer Senior, Drug Product Tech Transfer (JP13213)
Location:Thousand Oaks, CA. 91320 (Hybrid)
Business Unit:Commercial Drug Product
Employment Type: Contract
Duration:1+ years with possible extension or conversion to FTE
Rate
: $44 - $50/Hours W2 with benefits
Posting Date:09/30/2024
Notes:On site minimum 3 days per week.

3 Key Consulting is hiring! We are recruiting a Senior Engineer
for a consulting engagement with our direct client, a leading global biotechnology company.

Technical Skills
:
Drug product fill finish processing, Holistic DP process knowledge.
Technical transfer, drug product manufacturing, regulatory filings.

Job Description:

• The Sr Engineer will drive excellence and innovation in both large and small molecule drug product manufacturing at. As a key player in our global Process Development organization they will be instrumental in ensuring the highest standards of process performance, while also leading the charge in innovative process improvement strategies.
• Acts as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in formulation, filtration, filling (vials/syringes/devices) and lyophilization of parenteral products.
• Develops and characterizes drug product processes and transfers new technologies to commercial sterile fill/finish sites.
• Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation.
• Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
• Leads and participates in global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.
• Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine true root cause.
• Authors and reviews guideline documents, technical protocols, reports, product impact assessments and regulatory submissions
• Identifies and implements operational opportunities for current and new sterile operations.

Preferred Qualifications

• Advanced degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field
• 10+ years of drug product process development experience in the pharmaceuticals/biotechnology industry
• Knowledge of/hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations
• Experience with unit operation for parenteral manufacturing (i.e. filling, filtration, mixing, etc.), specifically lyophilization would be an advantage.
• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability.
• Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
• Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent communication skills are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing.

Top Must Have Skill Sets:

• Specifically looking for downstream purification experience
• Strong communication - must be comfortable speaking to a group of 20+ manufacturing associates in presentation (data reviews/etc.)
• GMP experience highly preferred (Looking for GMP background/ someone who has dealt with FDA/ inspectors/ auditors)

Day to Day Responsibilities:
Create and update manufacturing process documents, work with cross functional teams on product specific investigations, complete laboratory investigations and perform routine testing, monitor…