Site Leader
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København
Production
Position Summary
Directs and coordinates activities of all departments: Engineering, Finance, Manufacturing, Product Transfer, Materials/Purchasing, Validation and Human Resources. Ensures site maintains compliance with all local and Federal agencies in the areas of Environmental, Product Safety and Tax laws.
Key Responsibilities
- Responsible for adherence to the manufacturing plan for the plant site which also includes responsibility for the site operating budget, cost of goods, capital, etc.
- Responsible for the overall direction, coordination and evaluation of Engineering, Materials, Manufacturing, Finance, Product Transfer, Validation and Human Resources.
- Ensures compliance with company standards for cost control, waste reduction, quality, safety and complete on time delivery.
- Develops long-range strategic plan to help reduce cost and add to the company's bottom line.
- Plans, organizes, integrates and reviews staff resource input with the production organization, to successfully meet current production demands and direct a continuous planning strategy to maximize the facility's capability to meet future commitments.
- Support all corporate direct projects from the plant level.
- Leads Xellia Cleveland Manufacturing Facility. Provides Coaching and Leadership directly and indirectly to 35-40 Employees with managerial responsibility.
- Ensures continued development of staff so that they maintain high standards for manufacturing.
- Work closely with Quality Unit to ensure that the trends are leading in the right direction, which helps support producing a quality product with an acceptable time and cost.
- Develops operational plans that contribute to 30- 50% of the Xellia’s Finished Product Revenue/EBITA . The unit will be responsible for release, packing and distribution of all products to USA
- Actively supports and engages Xellia’s Customers and supports Business Development activities.
- Responsible for ensuring compliance activities required by a CGMP manufacturing environment are met according to regulatory agency standards.
- Effectively engages internal and external stakeholders and skill to be able to communicate and build consensus on strategic decisions.
- Responsible for ensuring safe and compliant production operations in relation to governmental and regulatory agencies which oversee environmental, safety, transportation, and labor requirements.
- Oversees drives execution of and the capital investment efforts which include project management efforts related to the design, installation and commissioning of production operations to ensure on time in-full production.
- Exercises sound judgement to deliver cost efficient production while ensuring optimal quality and timely product fulfilment.
- Leads and influences long-term strategy in coordination with Global Product Supply executives and peers.
- Provides input into strategic business direction and commercialization opportunities.
- Interfaces with internal and external stakeholders including country officials, regulatory agencies, employees and consultants.
- Acts as an agent for the organization to lead communications with officials, partners, and the community.
- Collaborates with global leaders in a matrixed organization responsible for business unit, functional, and commercial development decisions.
- Provides input into and influences strategic direction of Xellia’s Global Product Supply organization.
- Oversees work product of 70-100 project management and engineering resources.
- Accountable for commercial production of finished pharmaceutical ingredients.
- Leads teams of Executive, Supervisory and technical resources responsible for operations and business support employees (170-200 Employees).
- Exercises a high degree of judgement that impacts project timeline objectives, production deliverables, and operational productivity.
- Accountable for numerous external stakeholders and regulatory agencies with significant auditing and enforcement capabilities.
- Scope of operational production capabilities and product supply impact majority of US market.
- Scope of production is a significant impact to Company Revenue and EBITA contribution.
- Extensive knowledge of industry trends including regulatory changes and emerging practices.
- Skilled in the development and deployment of specialized methods, proprietary equipment, and highly skilled personnel.
- Accountable for culture development, leadership pipeline planning, and talent development.
- Directs development of business unit communications and branding strategy.
Requirements
- B.A. degree in Management, B.S. in Pharmacy, Engineering or related field. Master’s degree preferred.
- 10-15 years of experience in pharmaceutical manufacturing in a cGMP environment required
- 5-10 years’ experience in aseptic operations
- Must demonstrate progressive levels of managerial experience and broad span of organizational control
- Management experience in a start-up preferred.
- Prior Management experience with P&L responsibility, preferably in a global organization.
- Excellent written and verbal communication skills. Must be able to communicate and interact with all levels of the organization and manage in a dynamic environment to meet plant and company objectives
- Must be able to interpret financial information.
Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.
Read more about Xellia Pharmaceuticals here
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 13.8.2020, men kan have været deaktiveret og genaktiveret igen.
- Øvrige
- København
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