Sr Manufacturing Technical Specialist (Purification)

Location: Fully site-based in Vacaville, California, United States

Salary: $130,500–$217,500 gross annual base salary, plus a performance-related bonus.

Company

hirify.global operates more than 30 sites across five continents and manufactures medicines through globally connected life sciences teams.

What you will do

• Provide scientific expertise and serve as the technical subject-matter expert for complex purification process decisions.
• Collaborate with Manufacturing, Process Development, Quality, site stakeholders, and network teams on technical knowledge transfer and commercial product support.
• Drive process optimization, troubleshooting, new process evaluations, process monitoring, and product/process health management.
• Maintain cGMP compliance and the validated state of purification manufacturing processes.
• Support regulatory submissions, health authority interactions, inspections, change management, and significant product or process quality investigations.
• Lead complex projects, represent the Vacaville MSAT function across site and network teams, and mentor or review the work of other team members.

Requirements

• Bachelor’s degree in life sciences or engineering; an advanced degree is preferred.
• 10 or more years of pharmaceutical industry experience, including purification of drug substance protein therapeutics and work across multiple disciplines.
• Expertise in purification and separation sciences for drug substance protein therapeutics.
• Experience with technology transfers, process validation, regulatory submissions, health authority interactions, inspections, and product or process quality investigations.
• Strong knowledge of cGMP requirements, health authority regulations, and quality systems.
• Experience with OSI PI, R, SAS JMP, SQL, or Tableau is desirable.

Culture & Benefits

• In-person collaboration in a site-based manufacturing environment.
• Performance-related bonus.
• Medical, dental, and vision insurance.
• 401(k) matching plan.
• Life insurance, short- and long-term disability insurance, employee assistance programs, and paid time off.