Engineer, Drug Product Manufacturing Technologies; JP

Position: Engineer, Drug Product Manufacturing Technologies (JP12916)

Job Title: Engineer, Drug Product Manufacturing Technologies (JP12916)

Location: Thousand Oaks, CA. 91320

Business Unit: MCS:

Commercial Drug Product

Employment Type: Contract

Duration: 5+ months (with likely extensions)

Rate

: $38.00 - $42.00

Posting Date: 6/20/2024.

Notes: Only qualified candidates need apply. Must be local to Thousand Oaks, CA. (can work from home 1-2 days a week). Masters Degree is HIGHLY PREFERABLE. Pharmaceutical industry experience is a must. Ideally 2 years of work experience in the Pharmaceutical space. Must be an independent worker.

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

Job Description:

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 client products.

The candidate will assist in establishing the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.

Top Must Have Skill Sets:

• Masters Degree
• Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development in pharmaceutical industry setting and manufacturing.
• Knowledge of and hands-on experience with various drug product technologies.
• Pharmaceutical industry experience.
• Independent worker.

Day to Day Responsibilities:

• 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 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

Basic Qualifications:

• Master degree.
• Degree and 2 years of relevant experience.
• Educational background in Chemical Engineering, Biomedical Engineering, Biotechnology correlated technical field of study in biotechnology, life sciences or related discipline.
• Knowledge in scientific principles of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
• Ability to work on multiple projects simultaneously, learn new techniques, keep accurate records, follow SOP’s and instructions in compliance with company policies, and comfortable to operate in a very flexible, agile environment.
• Ability to independently design and execute characterization studies, author characterization protocols, process transfer documents, application notes and technical reports.
• Proficiency…