Senior Manager - Clinical Manufacturing Science & Technology (Biotech)

TL;DR

Senior Manager - Clinical Manufacturing Science & Technology (Biotech): Leading and coordinating end-to-end technology transfer activities for molecules into manufacturing sites within the Clinical Supply Center with an accent on regulatory compliance and process optimization. Focus on streamlining tech transfer workflows, mitigating risks in GMP environments, and building cross-functional upstream and downstream capabilities.

Location: Onsite in South San Francisco, CA or Oceanside, CA, USA

Salary: $146,500 - $272,100

Company

hirify.global, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for serious and life-threatening diseases.

What you will do

• Oversee end-to-end technology transfer for molecules into receiving manufacturing sites, including transfer plans, risk assessments, and master batch records.
• Champion standardization initiatives to streamline tech transfer workflows and ensure network alignment with global teams.
• Lead the authoring and review of regulatory filings and documents to ensure full compliance and readiness for inspections.
• Manage the ownership and timely closure of Quality Events and Planned Events, ensuring robust analysis and systemic remediation.
• Lead and mentor a team of individual contributors with a focus on building end-to-end upstream and downstream capabilities.
• Cultivate partnerships within the Clinical Supply Center and across Roche functions to ensure operational consistency.

Requirements

• B.S. Degree in Engineering or a related discipline.
• 12-15 years of experience in pharmaceutical/biotech (10-13 years with a Master's Degree).
• 5+ years of supervisory experience.
• Ability to execute complex projects in a GMP environment.
• Deep understanding of current GMP requirements and regulations.
• Strong strategic thinking, interpersonal communication, and problem-solving skills.

Culture & Benefits

• Competitive salary range with a discretionary annual bonus based on performance.
• Access to a state-of-the-art large molecule drug substance facility using single-use technology and digital manufacturing.
• Work environment that values an entrepreneurial spirit, agile mindset, and cross-functional collaboration.
• Comprehensive corporate benefits package for full-time employees.
• Commitment to equal opportunity and diversity in the workplace.