Senior Director, External Manufacturing Job Job in Basking Ridge, New Jersey US

Job Title:
Senior Director, External Manufacturing

Job ID:
12852

Location:

Basking Ridge, NJ -110
Offsite Territory:
Full/Part Time: Full-Time

Regular/Temporary:
Regular

Category:

Manufacturing/Tech Ops

Department:

Manufacturing - 1101

Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Life Sciences or Engineering degree; advanced degree (MBA) preferred.
15+ years related experience in the pharmaceutical industry.
10+ years related experience in cGMP/FDA regulated manufacturing facility.
.

The Sr. Director, External Manufacturing plays a key leadership role in Technical Operations with responsibility and accountability for the oversight of the manufacturing of Celgene commercial products via multiple global third party manufacturing facilities. This position ensures consistency in managing these external relationships. The primary function of this position will be to oversee the startup and ongoing performance of multiple international contract manufacturing factories for both existing and new technologies and products. The incumbent will be responsible for implementation of strategic initiatives at factory locations to best meet Celgenes requirements for quality, compliance, technology, delivery and cost. This position will work closely across both factory and corporate functions to integrate the corporations policy, process and technology for best results.

Responsibilities will include, but are not limited to, the following:

* Oversees team who serve as the primary relationship managers with multiple international contract manufacturing factories. Provide primary point of contact for day-to-day decision making and elevation/resolution of issues from both Celgene and external organizations.
* Direct the activities of multiple international contract manufacturing factories in order to produce the required semi-finished or finished products.
* Create the strategy and develop policies across a matrix organization to ensure factory problems and questions are resolved quickly and root cause corrective actions are implemented and standardized.
* Accountable for all aspects of performance for assigned factories with the primary focus being the delivery of quality product, on-time at a reasonable cost.
* Ensure global processes, procedures and standards are implemented at assigned factory facilities and oversees audits designed to verify compliance.
* Aid in the negotiation of supplier contracts and agreements, including development of key commercial terms, performance indicators and compliance requirements.
* Ensure Celgene and contract manufacturing factories are working in compliance with approved contracts and agreements.
* Prepare and implement long-term capacity, risk management and performance improvement plans for assigned factories.
* Oversight, management and approval authority over annual cost of goods budgets and related factory expenses. Annual spend will be in the range of $10 - $100 million.
* Work with global planning and sourcing groups to implement our short, mid, and long-term production strategies.
* Oversees team who ensure the materials and components required by each factory are sourced from approved suppliers and meet the applicable quality and compliance requirements.
* Oversees team who establishes and maintains adequate safety stocks of materials, components and semi-finished product as required.
* Approve work orders and purchase orders for assigned factories. Review and approve invoices/payments.
* Lead the evaluation, planning and implementation of process/product changes within the factory and maintain compliance with global regulatory filings and approvals.
* Provide operational, financial and decision support analysis to senior Technical Operations management.
* Provide senior management with timely, reliable and well structured information regarding factory performance including tracking of KPIs, variance analysis and contingency plans for corrective measures.
* Participate in the Sales and Operations Planning (SOP) process and implement any related initiatives.
* Ensure ERP (Oracle) system data for assigned factories and assure related system transactions are completed in a timely manner.
* Ownership and understanding of assigned products, processes and technologies.
* Oversee technology transfer projects and activities at assigned factories.
* Participate in product development or commercial launch teams for specific products
* For each assigned factory, ensure compliance with environmental, health and safety requirements related to the manufacturing, packaging or distribution of assigned products
* Develop the business and financial objectives for major supply chain projects and evaluate alternative solutions as basis for senior management decision.
* Ensure performance scorecards are in place to ensure the consistent implementation of KPIs with 3rd party contracts.

The incumbent will also be responsible for working with Celgene senior and executive management for the development of:

* Long term strategic plans and annual budgets to meet the ongoing needs of supply chain operations.
* Policies, procedures and systems to assure appropriate operational control and risk mitigation across entire supply chain.
* Plans and actions to assure the necessary steps are taken to prepare the Celgene supply chain to support new product launches, product in-license operations, new market and trading partner opportunities, and other supply chain related activities.
* Responsible for coordinating with internal manufacturing operations to ensure consistent performance across internal and external manufacturing and overall compliance to Celgene policies and quality systems.

Skills/Knowledge Required:

* Hands on knowledge and technical understanding of assigned products, processes and technologies.
* Hands on experience in manufacturing or packaging of pharmaceutical products.
* Understanding of pharmaceutical manufacturing related key performance indicators (KPIs) and operational metrics.
* Knowledge and experience in cost of goods management and corresponding financial impact of business decisions.
* Demonstrated ability to oversee a complex project which incorporates the use of tools such as Gantt charts, critical path analysis, risk mitigation strategies and project management software. Understands how these tools are used and directs team in their proper use.
* Global operations experience, import / export operations, working knowledge of regulatory, drug licensing, and operating requirements in a global market.
* Must possess highly developed project management, communication and analytical problem solving skills
* Experience with the development and validation of manufacturing/packaging processes or analytical methods
* Excellent written and oral communication skills in a global environment
* Enterprise Resource Planning (ERP, Oracle) system experience and understanding of purchasing, planning, scheduling, inventory management and manufacturing information and related transactions.
* Demonstrated experience in establishing and maintaining supplier/contractor relationships.
* Demonstrated experience in managing external manufacturing or packaging operations.
* Working knowledge of international GMP requirements and quality systems
* Ability to raise levels of performance by establishing an improvement process, or setting specific, measurable targets and goals linked to business needs.
* Demonstrated leadership skills and ability to develop effective working relationships with internal/external partners and cross-functional project teams.
* Proven ability to make independent and objective decisions and to work with minimal direct supervision.
* Strong team player with high level of integrity, energy and enthusiasm.
* Willing to travel 25% domestically and internationally often on short notice.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employees temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120321