Senior/Principal Technical Development Leader

TL;DR

Senior/Principal Technical Development Leader (CMC): Leading Technical Development Teams to craft and drive Chemistry, Manufacturing, and Control (CMC) strategies for clinical drug candidates from early human trials through product launch with an accent on CMC decision-making, risk mitigation, and cross-functional execution. Focus on building multifaceted technology strategies across manufacturing, drug product/device configurations, supply chains, and regulatory submissions while managing highly complex projects under ambiguity.

Location: South San Francisco, California, United States of America

Salary: $169,100 to $314,000 (Senior TDL) OR $194,900 to $361,900 (Principal TDL)

Company

hirify.global, a member of the Roche Group, develops medicines through advanced biotechnology and R&D.

What you will do

• Lead CMC Technical Development Teams across the asset lifecycle, ensuring scientific integrity of the CMC strategy.
• Develop and execute CMC technology strategies covering manufacturing processes, drug product and device configurations, supply chains, and regulatory submissions.
• Oversee manufacturing and delivery of clinical supplies, manage CMC development costs, and ensure timelines, milestones, and resource forecasts are met.
• Serve as primary decision-maker for CMC development, investments, and risk management; anticipate issues and build contingency plans.
• Provide enterprise-wide strategic insights and maintain transparent updates to project teams, senior management, and governance committees.
• Represent Pharma Technical functions on asset/lifecycle teams and partner with leaders to align CMC strategy with broader company goals.

Requirements

• B.S./M.S./Ph.D. in chemistry, pharmaceutics, chemical engineering, or a related field.
• 10–15+ years of experience in the pharmaceutical industry, including prior experience as a CMC team leader.
• Strong technical knowledge of large-molecule process and product development.
• Advanced understanding of the drug development process and a track record of successful innovation in CMC/product development.
• Proven ability to lead teams and solve complex problems/manage highly complex projects in high-ambiguity situations.

Culture & Benefits

• Discretionary annual bonus may be available based on individual and company performance.
• Relocation benefits are available for this job posting.
• Benefits package available (details provided in the posting).
• Equal opportunity employer.

Hiring process

• Apply through the company careers portal.
• Interviews and evaluations are not detailed in the provided text.