Associate Director, Tech Transfer & Lifecycle Lead 80-100% (Drug Product)

Location: Fully site-based in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families.

Company

hirify.global develops and manufactures medicines, with teams supporting scientific breakthroughs and products reaching patients worldwide.

What you will do

• Lead complex Drug Product technology transfer and lifecycle programs from clinical development through process validation, regulatory submission, commercialization, CPV/OPV, and lifecycle management.
• Serve as the senior technical authority for customer programs, defining commercialization and validation strategies, providing technical governance, and escalating critical manufacturing, process, and compliance issues.
• Transfer, scale up, and implement Drug Product manufacturing processes into GMP operations, supporting manufacturing readiness, commercial launch, and sustainable routine production.
• Develop and oversee Stage 1, Stage 2, and Stage 3 process validation, including risk assessments, PPQ, statistical evaluation, trend analysis, process monitoring, and post-approval change assessments.
• Collaborate with Manufacturing, MSAT, QA, QC, Regulatory Affairs, Supply Chain, customers, and other stakeholders on milestones, regulatory submissions, and PAI and GMP audit readiness.
• Mentor Technology Transfer Leads and MSAT experts while harmonizing SOPs, validation standards, CPV frameworks, and lifecycle management processes across the global manufacturing network.

Requirements

• Extensive experience in biopharma, pharmaceutical, or CDMO environments, with deep expertise in Drug Product technology transfer, process validation, and lifecycle management within aseptic fill & finish manufacturing.
• Strong technical knowledge of aseptic processing, including biologics, lyophilization, prefilled syringes, sterilization processes, and primary packaging.
• In-depth understanding of GMP, CMC, and global regulatory requirements, with experience supporting commercialization, regulatory submissions, validation activities, and post-approval changes.
• Demonstrated success leading complex technology transfer and commercial launch programs, influencing cross-functional stakeholders, and driving strategic decisions in fast-paced manufacturing environments.
• Expertise in Stage 1, Stage 2, and Stage 3 process validation, including PPQ, CPV/OPV, process performance monitoring, statistical data analysis, trend evaluation, and continuous process improvement.
• Excellent communication, stakeholder management, and leadership skills, including the ability to mentor technical teams, manage complex customer interactions, and deliver results across global and cross-site networks.

Culture & Benefits

• Full-time role with an agile career environment and dynamic working culture.
• Inclusive and ethical workplace focused on collaboration, ownership, learning, and meaningful responsibility.
• Compensation programs recognizing high performance.
• Benefits vary by role and location, with global and local benefit programs available.
• In-person collaboration supports real-time teamwork and the technical precision required for high-quality, safe medicine manufacturing.