Associate Director Of Process & Support Operations (m/f/d)

Associate Director Of Process & Support Operations

Our Company in Schachen serves as a magnetic force that attracts, recognizes, and integrates people from diverse backgrounds and perspectives. Employees feel not only that they belong at Schachen, but that the site belongs to and is shaped by them.

Our Company is a premier, state-of-the-art facility that integrates advanced technologies into the early-stage clinical pipeline, refining them for future commercial launch. The site supports biologics drug substance manufacturing for early-phase clinical supply and serves as a hub for technology innovation and strategic advancement.

Purpose of Role:

Reporting to the Director of Manufacturing Operations, we are currently seeking an Associate Director of Process & Support Operations to play a pivotal role in leading both day-to-day manufacturing execution and strategic support functions with focus on cultivating people leadership and operational excellence. This role ensures the facility operates with agility and readiness to support a multiproduct pipeline for early-phase clinical supply. The Associate Director oversees shop floor operations, production planning, and operational readiness for new product introductions (NPIs), while driving digitization, automation, and continuous improvement. The role manages a team of direct-report specialists and functional managers, fostering a culture of safety, compliance, and performance excellence. As a member of the Schachen Biotech Manufacturing Operations Leadership Team, reporting to the Director of Manufacturing Operations, the Associate Director is responsible for the reliable, efficient, and cGMP-compliant execution of production campaigns, delivered right-first-time and on schedule. This includes oversight of batch record review, deviation management, campaign reporting, and calibration activities, ensuring these are executed to the highest standards by the team.

Key Responsibilities:

Leadership & Culture:

• Lead a diverse team of specialists and functional managers, fostering a culture of empowerment, accountability, collaboration, and trust.
• Build team capabilities through hiring, mentoring, coaching, and performance development fostering a high-performance culture rooted in operational excellence.
• Promote the Company’s Ways of Working by embedding a "Safety First, Quality Always" mindset and fostering high-performing teams across all operational areas.
• Drive continuous improvement and innovation, encouraging agility and adaptability in a multiproduct environment. Act as an organizational architect and change catalyst by shaping and reshaping team structures and capabilities through strategic use of skill matrices and workforce planning.
• Represent the Process & Support Operations function in cross-functional forums and contribute to site-wide strategic initiatives.

Operational Management:

• Oversee day-to-day manufacturing process execution and support operations, ensuring readiness for clinical campaigns and alignment with GMP standards.
• Lead production planning, resource allocation, and coordination of shop floor activities in line with New Product Introduction (NPI) schedules.
• Support process implementation for NPIs, including integration of new materials, equipment, and procedures into routine operations.
• Ensure personnel are appropriately trained and qualified for assigned tasks, maintaining operational readiness and compliance.
• Oversee batch record review, deviation management, campaign reporting, and calibration activities to ensure consistent and compliant execution.
• Drive operational simplification by eliminating non-value-added activities and reducing effort and cost through digital solutions, including robotic process automation (RPA). Champion digitization and automation to enhance efficiency, agility, and readiness for clinical campaigns.
• Collaborate cross-functionally to ensure tech transfer readiness and contribute to Quality Risk Assessments (QRAs).
• Drive harmonization of standards and sharing of best practices across the network to reduce local workload and accelerate product launch.

Quality & Compliance:

• Ensure deployment of Quality Management Systems (QMS).
• Act as business approver for complex and high-impact GMP documentation, including validation protocols, change controls, and deviation records.
• Support the resolution of complex deviations and CAPAs in collaboration with Quality and Regulatory Affairs.
• Facilitate Quality Risk Assessments (QRAs) and support internal and external audits.

Required Qualifications:

• Bachelor's or Master's degree in biology, Chemical Engineering, or related discipline.
• Minimum 8 years of experience in GMP-regulated biologics manufacturing, including upstream and downstream processing, tech transfer, and single-use systems.
• Proven leadership experience in manufacturing operations and technical implementation.
• Excellent oral / written communication skills in English (C1) and German (B2).

Preferred Experience and Skills:

• Familiarity with multiproduct manufacturing strategies and campaign planning.
• Knowledge of digital manufacturing platforms (e.g. DeltaV, MES).
• Qualification and Training in LEAN management, or operational excellence methodologies.

The Company:

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich, aimed at accelerating the development and commercialization of many of our company's medicines and vaccines, which supports our mission to save and improve lives around the world.

We are proud to be certified as a "Top Employer Switzerland" and "Top Employer Europe" showing the company's commitment to our employees and the community around us.

Our Schachen site is crucial for the development and supply of innovative medicines. With over 400 employees, we focus on producing and testing new biological medicines. From Schachen, we export new drugs for global clinical trials, ensuring their safety and efficacy. Additionally, our site investigates suspected cases of drug counterfeiting, operating as one of only three such laboratories worldwide.

Required Skills:

Communication, Cross-Cultural Awareness, Digital Manufacturing, Digitizing, GMP Compliance, GMP Environments, Leadership, Lean Management, Maintenance Supervision, Management Process, Manufacturing Operations, Manufacturing Processes, Manufacturing Quality Control, Operational Excellence, People Leadership, Pharmaceutical Development, Process Engineering, Process Improvements, Production Management, Production Planning, Quality Management, Regulatory Compliance, Regulatory Inspections, Robotic Process Automation.

Preferred Skills: