Apply to 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 process data, imitate and lead meetings related to product initiatives

Basic Qualifications:
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

Why is the Position Open?
Supplement additional workload on team.
Red Flags:
No experience or short tenures with other jobs.
No experience owning and taking on projects.
Not able to come onsite 3 days onsite.

Interview Process:
Phone/ Webex, 2-3 rounds of interviews.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.