Job Description

Director Manufacturing Operations (m/f/d)

The Biotech facility embeds the latest technologies into the early stage clinical pipeline, helping to refine these technologies for inclusion into the late-stage and commercial launch of programs.  By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. Schachen Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline.

The Director Manufacturing Operations (m/f/d) leads an Operating Unit responsible for manufacturing biologics drug substance in an efficient and timely manner through application of state-of-the-art technologies for batch and continuous manufacturing  with a Quality First, Safety Aways Mindset.  The Director Manufacturing Operations (m/f/d) leads teams responsible for Technology Transfer, Process Operations, and Support operations.  The teams operate within a framework of regulatory compliance and established high standards of Quality, Good Manufacturing Practices (GMP) and Environmental Health & Safety protection. The Director Manufacturing Operations (m/f/d)  shapes the direction of the pipeline by integrating an innovative / strategic focus and a high customer service level, fostering a strong performance orientation and effectively collaborating across the organization. He or she ensures a culture of self-direction, empowerment and accountability, while providing the support necessary to team members working in a widely cross-functional organization.

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

Leadership:

Sets performance targets that align with business priorities and drives continuous improvement initiatives.

Develops the organization and culture (including values and behaviors such as empowerment, diversity, equity, and inclusion, accountability, trust, open communication)

Drives 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 and drives talent retention.

Builds and sustains strong networks in and outside the organization

Management:

Ensures that all aspects of operations within the facility comply with our compliance and safety policies and standards

Oversees planning and coordination of Manufacturing Operations activities including manufacturing and process technology transfers.

Designs and operationalizes technology transfer processes that deliver right first-time manufacturing of biologics to support the pipeline.

Manages the allocation of resources (including assets), costs and investments efficiently

Responsible for budgets and management of unit costs, capital investments and headcount

Contributes in his/her role within overarching business planning process driving towards fully integrated planning of clinical supply

Identifies and implements continuous improvement initiatives

If you are passionate about leading innovative manufacturing operations and meet the qualifications listed, we encourage you to apply and join our dynamic team.

Required Education, Experience 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 drug substance manufacturing using mammalian cell culture, including upstream and downstream processing

Experience in leading cross-functional teams (Manager of Managers)

Working knowledge of cGMP regulations

Demonstrated supervisory and leadership skills

Excellent oral / written communication skills in English (C1),  and German (B2)

Preferred Experience and Skills: 

Qualification and training in economics and LEAN management

Experience with evolution of regulatory requirements

Experience with Cross-Functional Investigations and Root Cause Analysis Techniques.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

01/10/2025

*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:R326868