Contract Manufacturing Exp with project managment

Top 3 Must Have Skill Sets:

• Biotech or pharma operations experience
• Project management skills
• Communication skills

Day to Day Responsibilities:

• The Specialist may work on a wide range of activities to support ACM Business Operations and Strategy that may include but are not limited to:
• Development of Request for Proposal and Scope of Work for new site selections
• Facilitating cross functional review of contract manufacturing proposals
• Financial analysis to develop business cases of proposed projects and tracking of project related spending
• Use modeling and analytical tools to identify improvement opportunities and focus areas to drive strategy and business performance
• Present recommendations to Senior Management and drive decisions
• Project Management of medium to high complexity technology transfers to CMOs and other special projects as needed
• Support development and implementation of new processes and procedures to standardize, simplify, and measure business processes within Amgen Contract Manufacturing
• Provide regular reports, dashboards and presentations that clearly summarize results and implications/recommendations to key stakeholders to inform decision making
• Lead continuous improvement projects that deliver measurable gain in quality, efficiency and alignment within Amgen.
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Summary

• Contract Manufacturing (ACM) provides a strategic dimension to companies manufacturing network to enhance operational competitiveness and ensure uninterrupted global supply of medicines to our patients.
• The ACM network currently encompasses production for Drug Substance, Drug Product, and Finished Drug Product for both biologics and small molecule production.
• The Contract Manufacturing Specialist works to enable site selection, tech transfer, and business evaluation projects that are focused on ensuring quality and reliability of supply from companies external network.
• Often management of these projects requires leading a cross functional team of ACM’s key business partners including Process Development, External Supply Quality, Supply Chain, Finance, Operations Strategic Planning and Risk, and Global Strategic Sourcing.
• The Specialist may work on a wide range of activities to support ACM Business Operations and Strategy that may include but are not limited to:
• Development of Request for Proposal and Scope of Work for new site selections
• Facilitating cross functional review of contract manufacturing proposals
• Financial analysis to develop business cases of proposed projects and tracking of project related spending
• Use modeling and analytical tools to identify improvement opportunities and focus areas to drive strategy and business performance
• Present recommendations to Senior Management and drive decisions
• Project Management of medium to high complexity technology transfers to CMOs and other special projects as needed
• Support development and implementation of new processes and procedures to standardize, simplify, and measure business processes within companies Contract Manufacturing
• Provide regular reports, dashboards and presentations that clearly summarize results and implications/recommendations to key stakeholders to inform decision making
• Lead continuous improvement projects that deliver measurable gain in quality, efficiency and alignment within company

Experience Level:
3-5 years

Education:

• Bachelors in Science or Engineering preferred, MBA is ideal
• 2+ years of project management experience leading medium to complex projects
• Biotech or Pharma experience required
• Familiar with six sigma concepts
• Ability to travel +/- 20% of time (domestic and international)
• Strong analytical skills and knowledge of analytical tools within MS Excel.
• Advanced knowledge of PowerPoint, Microsoft Word, and Microsoft Project.
• Ability and interest to learn to use other software as required.

Preferred Requirements:

• Extensive knowledge and expertise in the use of project management methodologies and tools, resource management practices and change management techniques
• Understanding of biological/chemistry technology transfer processes and timelines

Competencies

• Demonstrate and apply a strong understanding of Operations including: Large and Small Molecule Drug Substance, Drug Product and Packaging manufacturing, Supply Chain, Quality and associated financials
• Knowledge and understanding of international pharmaceutical industry and business principles, developments and trends as they relate to companies contract manufacturing business objectives
• Excellent organizational skills and attention to detail
• Demonstrated ability to think and act strategically to support key business decisions
• Excellent analytical skills—ability to translate disparate and ambiguous data sets into actionable insights and recommendations
• Strong oral, written and presentation skills with ability to explain complex concepts clearly to a variety of audiences
• Proficient facilitation, negotiation, problem-solving and change management skills
• Superior ability to work in a self-directed manner while balancing a fast-paced environment with multiple priorities and competing demands
• Ability to turn unstructured business issues/requests into appropriate action plans and projects that result in high quality, meaningful and actionable deliverable
• Continuous improvement mindset
• Own, build and maintain strong relationships with stakeholders; proactively seek buy-in and provide on-going collaboration and consultation to inform how best to address business needs
• This role will report to the Senior Manager of Contract Manufacturing in the Contract Manufacturing Business Operations and Strategy team and will be based on main corporate campus in Thousand Oaks, CA.
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