Engineer, Process Development - Biopharma

Job Title : Engineer, Process Development - Biopharma (JP12137)

Location : Thousand Oaks, CA. 91320

Business Unit : Commercial Drug Product

Employment Type : Contract

Duration : 1+ year(s) (with possible extensions)

Rate : $38 - $42 / hour W2

Posting Date : 01 / 08 / 2024

Notes : Hybrid : Working on site 25-50% of the time in Thousand Oaks, CA (some weeks you'll need to be there every day, some weeks not at all depending on contract need but MUST BE LOCAL)

Highly prefer Master's degree with experience or Bachelor's degree with at least 3 years of experience.

3 Key Consulting is recruiting a Process Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description :

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 client's 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

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

Preferred Qualifications

Top Must Have Skill Sets :

Day to Day Responsibilities :

Support Process Development studies for multiple commercial programs with activities to tech transfer into new manufacturing suites or undergoing process improvement activities.

Red Flags :

This role will be a hybrid role. We can provide some flexibility for WFH, but working on-site as projects need is expected. Some weeks may be completely WFH, but some may require every day on-site work.

Interview Process :

Phone interviews is sufficient.

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.

Regards,

3KC Talent Acquisition Team