Associate Director of Upstream Process (USP) Operations (m/f/d)

Job Description

Our Company`s Schachen site 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.

Schachen Biotech 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.

The Associate Director of Upstream Process (USP) Operations plays a pivotal role in leading both day-to-day USP manufacturing execution (vial thaw, seed train, and bioreactor operations through harvest) 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 USP 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 USP production campaigns from vial thaw to harvest, delivered right-first-time and on schedule. This includes oversight of process implementation activities for new and existing products, batch record review, deviation management, campaign reporting, and calibration activities, ensuring these are executed to the highest standards by the team.

Leadership & Culture:

• Lead a diverse team of process specialists and operators within USP operations, 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 our 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 USP 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 USP 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 specific to upstream unit operations (e.g. seed reactors, production bioreactors, harvest systems), and lead execution of process implementation activities across USP, ensuring successful translation from tech transfer to routine manufacturing 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), with focus on USP process robustness and scalability.

• 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 6 years of experience in GMP-regulated biologics manufacturing, including strong expertise in upstream processing (cell culture, seed train expansion, and bioreactor operations), 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.

Required Skills:

Computerized Maintenance Management Systems (CMMS), Cross-Cultural Awareness, GMP Environments, Maintenance Supervision, Manufacturing Quality Control, People Leadership, Pharmaceutical Development, Process Engineering, Process Improvements, Regulatory Compliance, Regulatory Inspections, Single-Use Systems (SUS), Sterile Manufacturing, Strategic Thinking, Team Leadership

Preferred Skills:

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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:

No relocation

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:

06/26/2026

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