WHAT YOU NEED TO SUCCEED (MINIMUM QUALIFICATIONS):

• Education: Bachelor’s degree or equivalent in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
• Experience: 0 - 2 years’ experience in the Biotech / Pharmaceutical industry.
• Familiarity with tools such as JMP or Excel for data analysis is a plus.
• Ability to work in a team environment and support manufacturing activities on the production floor, including occasional off-shift or weekend support if required.
• Detailed understanding of biopharmaceutical production processes and technologies with working knowledge of cGMP standards and experience working in a regulated environment.

WHAT WILL GIVE YOU A COMPETITIVE EDGE (PREFERRED QUALIFICATIONS):

• MSc in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
• 3+ years’ experience in the Biotech / Pharmaceutical industry.
• Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes.
• Experience in tech transfer, scale-up, and validation of biopharmaceutical processes.
• Experience in capital project design, development, validation, and execution.
• Experience with electronic quality systems (e.g., Veeva QMS, TrackWise) and MES platforms.

YOUR RESPONSIBILITIES:

• Support the execution and troubleshooting of upstream and/or downstream manufacturing processes for biologics (e.g., mammalian cell culture, purification).
• Collaborate with Manufacturing, Development, and Quality teams in the execution of technical / development studies, investigations, validation activities, and technical transfer programs, and collaborate with team members to identify potential risks, sources of variability, improvement, and value engineering opportunities to maximize project return and likelihood of technical success.
• Provide on-floor support during manufacturing campaigns, including troubleshooting and deviation investigations.
• Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements.
• Author and provide critical review of technical documents, including, but not limited to: batch records, SOPs, PFDs, risk assessments, investigations, technical studies, commissioning and qualification protocols, and reports.
• Assist in implementing changes through the change control system (e.g., BOM updates, process changes).

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:

• Multiple relocation packages
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matchin