Sr Director Drug Substance Facility Lead

Job Description

Role Overview:

The Biologics drug substance manufacturing facility at Schachen is a premier, state-of-the-art facility that enables and advances our best work. The facility supports early clinical supply based on a seamless connection and collaboration between process development and clinical manufacturing.

Reporting to the AVP Biologics Process R&D, we are currently seeking a Senior Director level Drug Substance Facility Lead responsible for multiple business units for manufacturing high quality biologics drug substance through application of state-of-the-art technologies for batch and continuous manufacturing.

Facility Leadership: Overseeing operation of drug substance production suite, process engineering, automation, technology transfer and compliance. This role includes providing functional leadership in production support areas to facilitate the early phase pipeline, ensuring that technology functions and overall facility operations support early-phase biologics drug substances clinical supply. The Facility Lead plays a crucial role in ensuring the success of the business units by driving strategic focus and maintaining high customer service levels, fostering a robust performance orientation, and effectively collaborating across the organization.

Compliance and Regulatory: It is essential to ensure that all staff comply with relevant regulations, guidelines, and quality standards, including cGMP, FDA, and other regulatory mandates. Teams must adhere to regulatory compliance standards and maintain high levels of Quality and Good Manufacturing Practices (GMP). Additionally, prioritize and maintain a safe work environment by implementing and monitoring safety protocols to protect both employees and the surrounding community.

Production Planning, Process Optimization and Resource Management: Work with cross-functional teams to create production plans, ensuring effective capacity utilization and on-time product delivery. Optimize resource allocation and promote cost-effective practices while maintaining quality standards. Continuously identify and implement process improvements to increase manufacturing efficiency and product quality.

Business strategy execution: Establishing governance structures to meet site performance targets. It also includes identifying opportunities for process improvements and plant capability enhancements to increase site efficiency. The facility lead ensures BPR&D and site strategies are clearly communicated to all employees, fostering engagement and communication.

Activities within Role:

The primary activities include but are not limited to the following:

Leadership

• Embed safety, compliance, permanent inspection readiness throughout the organization.
• Drives accountability across the facility cross functional teams.
• Sets and monitors key performance targets in line with business priorities and develops long-term plans for the facility.
• Develops the organization and its culture (including values and behaviors such as empowerment, diversity and inclusion, accountability, trust, open communication)
• Driving a talent agenda leads people processes through recruitment, training, coaching and performance management to meet all operational requirements sustaining both global and local competitiveness and diversity.
• Establishes robust succession plans for operations and the site. Actively drives talent retention.
• Builds and sustains strong networks inside and outside the organization.
• Develops and drives a phase-appropriate strategy for flexible and agile delivery of Drug Substance as a key supply node in the network.

Management

• Ensures that all aspects of Manufacturing within the facility comply with our policies, standards, and regulatory expectations.
• Oversees planning and coordination of activities across the site including manufacturing, process engineering, automation and process technology transfers.
• Designs and operationalizes new product introduction that delivers right first-time manufacturing of biologics.
• Manages the allocation of resources (including assets), costs and investments efficiently.
• Manages budgets and organizational costs.
• Contributes within overarching business planning process driving towards fully integrated planning of clinical supply.
• Identifies and implements continuous improvement initiatives.

Require Education and Skills

• Bachelor's degree (B.S.) or equivalent in biology, chemical engineering, or a related discipline with at least 12 years or master's degree (M.S.) with at least 10 years previous experience in a relevant position in GMP manufacturing in the pharmaceutical or biotech industry
• Experience in Commercial drug substance manufacturing using mammalian cell culture, including upstream and downstream processing.
• Experience in tech transfer and leading cross-functional teams.
• Working knowledge of cGMP regulations across multiple markets
• Demonstrated supervisory and leadership skills and experience as manager of managers.
• Excellent oral / written communication skills in English (C1)

Preferred Experience and skills

• Qualification and training in economics and LEAN management

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:

Accountability, Accountability, Budget Management, Business Performance Management, Business Planning, Business Strategies, Cell Cultures, Chemical Engineering, Client Relationship Building, Construction Cost Estimating, Customer-Focused, Data-Driven Decision Making, Driving Continuous Improvement, Engineering Standards, Financial Operations Management, GMP Compliance, Innovation, Inspection Readiness, Leadership, Mammalian Cell Culture, Manufacturing Quality Control, Manufacturing Scale-Up, New Product Introduction Process, People Leadership, Process Engineering {+ 4 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

International

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

12/3/2025

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R373631