Sr. Director Msat, Large Molecule Drug Product

vor 24 Stunden

Schaffhausen, Schweiz Johnson & Johnson Vollzeit

Janssen Supply Chain is recruiting for a Senior Director, Large Molecule Drug Product for Janssen Manufacturing Science and Technology located in Schaffhausen, Switzerland, or other key Biologic Parenteral Manufacturing Plants.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have sought to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly
- based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, build healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.

Every day, our more than 130,000 employees across the world are blending heart, science and resourcefulness to profoundly change the trajectory of health for humanity.

This position has full accountability for Manufacturing Science and Technology (MSAT) for Drug Product (DP), Primary Container & Device (PC&D) within the Large Molecule (LM) DP Platform, providing technical & scientific leadership spanning the product life cycle from early development to launch & growth ensuring commercial readiness, value optimization and late stage. Responsibility includes Internal & a very broad External Manufacturing network across all regions.

The Senior Director, Large Molecule Drug Product partners with the Innovation & Technology Deployment Lead to ensure deployment of innovation and implementation of new technology The LM DP Lead drives process standardization and best practice sharing, across LM DP Platform; at internal sites as well as external. Leads diverse technical teams both site MSAT teams as well as global MSAT team and drives talent development, to encompass product technical ownership and support for the LM DP Platform. The LM DP Lead will create an organization of highly skilled technical expertise and profound scientific and manufacturing knowhow. This will allow the team to be a credible partner for R&D; both DPDS and clinical supply chain.

The Senior Director, Large Molecule Drug Product is responsible, in alignment with LM Drug Substance Platform Lead and the MSAT LT, for setting the strategy, priorities, goals and objectives, managing MSAT operations between & at the platform sites, thus achieving the goals of the manufacturing organization in line with LM Global Manufacturing Platform objectives.

This position reports to the VP MSAT, is a member of the MSAT LT and of the LM Manufacturing Platform LT; partners with R&D, Value Chain Mgmt, Quality, PES and Regulatory to align on strategy and maximize business outcome.

**Key Responsibilities**:

- Defines and directs MSAT LM DP platform organization (Sites/Global/External/D&P) - defines strategies, methods, and processes to assure technical and manufacturing integration from early development to launch & growth, value optimization and late stage
- Develop and maintains relationships with Key Stakeholders, including Site GM’s, R&D leadership, PES, Value Chain Management and Quality.
- Partners with LM R&D to influence the manufacturing strategy and new development platforms; partners with PC&D R&D to influence the selection of new devices constituents and primary packaging materials
- Contributes to business planning strategies in partnership with LM Global Manufacturing Platform Lead and translates business goals into LM DP MSAT Platform objectives. Approves and monitors the Platform budget, investigate and takes steps to resolve significant variances.
- Coaches, mentors and provides developmental opportunities to staff, evaluates performance and initiates corrective actions when necessary.
- Accountable for Initiatives and projects related to network reconfiguration, major cost improvement programs, implementation of new capabilities and capacity

**Qualifications** Education**:
A master’s degree is required; engineering, science or related degree.

**Experience and Skills**:
Required:

- A minimum of 15 years of experience in a pharmaceutical environment.
- Strong expertise in large molecule active pharmaceutical ingredient (API) technical transfer, manufacturing processes, validation, equipment, and regulations with focus on Large Molecule Drug Product technology.
- Proven understanding of Quality & Compliance / Regulatory Requirements/Safety (GMP/EH&S) especially for Large Molecule Drug Product Technology.
- Proven working knowledge in Supply Chain functions and financials.
- Collaborates optimally to achieve performance improvement.
- Establishes effective communications and common goals and objectives.
- Strong analytical and quantitative skills, excellent communication and presentation skills.
- Personal and interpersonal skills
- Leadership skills

Preferred:

- Experience with introduction of pharmaceutical products to manufacturing sites and late-stage development with working technical knowle

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