Contract Manufacturing Senior Manager (Site Lead and CTL Support)
Responsibilities:
Manufacturing operations: Develop and lead robust business processes, maintain reliable relationships with contract site management; assess industry trends, internal network, and technology advancements as tools to improve contract site performance. Manage budget development, monitoring, and reporting; create and manage contracts - confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.; monitor and improve financials with CMO; actively manage and communicate forecasts to the sites and manage capacity planning. Drive operational excellence and champion change.
Site performance monitoring: Manage contract site performance using lean tools and PDCA, lead site operating review meetings; drive improvements at contract sites; sustain and improve the overall health of the business, and lead communication/relationship with the contract site as well as internal management.
Project Management and Technology transfer: Lead a department-wide project from conception to implementation and close-out. Present to and obtain buy-in for value proposition of such projects to senior management. Provide oversight of all planning and coordination of product transfer activities to the contract site(s); develop, present, and obtain approval of budget, timeline and ensure execution of transfer team activities to achieve seamless product transfer to the contract site(s); ensure risk management initiatives are taking place as per RM plan; lead site issue management and resolution; provide issue escalation to executive management.
Contract testing lab (CTL) support: Managing laboratory supplier relationships, developing performance metrics, and building strong partnerships with external laboratories to enhance efficiency and program success. Oversee a portfolio of cross-disciplinary external projects, focusing on analytical testing activities such as method qualification, transfer, release, stability, and characterization with contract laboratories.
Preferred Qualifications:
Bachelor’s degree in Business Administration, Engineering or Science-related field
8+ years of experience in protein, API, DS, DP, or packaging manufacturing environment
8+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
5+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
3+ years of project management experience leading multi-functional and multi-location team
3+ years of experience across ACM or CMQ
Ability to travel +/- 20% of time (domestic and international).
Competencies:
Assimilates multiple inputs and allocates resources to potentially conflicting priorities
Anticipates and resolves complex problems and integrates into continuous improvement
Establishes and manages business budget
Strong influence and negotiation skills
Expertise in problem solving and risk-based decision-making
Demonstrated matrix management and organizationally savvy
Promotes and drives organizational change
Excellent project management skills
Mastery of contractual requirements
Demonstrated ability to lead effectively in collaborative/team environment
Demonstrated ability to take initiative, drive action, and work independently.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.