Job Title: Engineer – Biopharma Drug Product (JP9223) Location: Thousand Oaks, CA Employment Type: Contract Business Unit: Commercial DP Duration: 12 months with likely extensions Job posting date: 9/28/2021 Note: 10-25% onsite
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary: As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to various aseptic fill finish manufacturing plants and production lines. The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for liaising with various drug product teams to ensure successful technology transfer, with associated documentation, of products. The candidate will assist to establish the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.
Responsibilities include, but are not limited to, the following:
Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
Assist in the design and execution of experiments in order to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process transfer documents, and change control assessments
Support development of technology transfer tools (clinical and commercial)
Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
Author/review technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures
Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc.
Development of digital tools and models by leveraging data analytics and programming skills
B.S. in engineering or biotechnology discipline with 1‒3 years’ experience or M.S. in engineering or biotechnology discipline with 0‒2 years’ experience
Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development
Knowledge of and hands-on experience with various drug product technologies
Displayed critical thinking, problem solving and independent research skills
Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies
Excellent project management skills and ability to elevate relevant issues to project lead and line-management
Strong cross functional team player with good communication skills (oral and written)
Ability to work independently and as part of a team with internal and external partners
Good computer and organizational skills with strong attention to detail
Self-motivated with a positive attitude
Top Must have Skill Sets:
Employee Value Proposition: To work for a dynamic team
Red Flags: Frequent job changes
Interview Process: Phone screen followed by phone interviews
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.