Head of Development Contract Manufacturing Operations (CMO)
Global Pharma Procurement (Pharma Technical Operations)
Contract Manufacturing Operations
Head of Contract Manufacturing Operations (CMO)
Main Purpose of the Position:
Develop overall manufacturing outsourcing strategy and lead the s
election, implementation and management of clinical contract manufacturing and/or clinical distribution organizations that are needed to meet clinical pipeline supply requirements for drug substance, drug product (biologics, small molecules, antibody drug conjugates, new technologies, clinical labeling, packaging and/or distribution).
Establish and manage the manufacturing relationships with our existing and new development partners and establish long-term strategic relationships with CMOs that align with Roche’s outsourcing strategy.
Establish strategic goals and objectives
and ensure all business, operational and quality objectives are aligned with Roche’s development and manufacturing strategies and plans.
Provide the single point of accountability for achieving the business, operational and quality objectives, plans, and performance goals of Roche’s Development CMOs and customers.
Provide leadership and guidance to direct reports overseeing CMOs and/or Development Partners.
Manage performance and development of direct reports to ensure achievement of organizational and department goals and a productive work environment.
Manage and administer all aspects of people processes related to the employee life cycle.
This includes the selection, hiring and training of personnel on company and department policies, systems and processes.
Manage and communicate compensation related information per company guidelines.
Build a scaleable, robust, world-class organization that will deliver the business plan.
Coach and develop staff by providing an environment that encourages ongoing personal and professional growth.
Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year.
Ensure staff receives appropriate skills development and growth opportunities.
Develop and establish a strategic, collaborative CMO network supporting all our clinical programs, for biologics, antibody drug conjugates, small molecules and clinical drug distribution.
Ensure robust processes are in place for the evaluation, implementation and management of selected CMOs and development partners.
Negotiate contracts with CMOs and development partners.
Oversee technology transfers to our CMOs; participate in site visits and audits of CMOs.
Assess new in-licensing opportunities from a manufacturing, quality and product cost perspective.
Provide input to and rationale for department budget.
Monitor and control expenditures against department budget.
Be accountable for behaviors described in Roche’s Core Mission and Values.
Serve as the Procurement Business Partner and Category Leader for PTD.
This role is an indispensable, strategic procurement partner to senior leaders in PTD, helping to create an effective and integrated strategy for advancing the business based upon an in-depth understanding of the external marketplace.
Through deep knowledge of the client’s business needs, the PBP effectively recommends solutions and engages and brokers the appropriate resources to provide strategic procurement services that support successful achievement of business objectives and goals across multiple groups throughout the client organization.
This position is accountable for aligning the Tech Ops Procurement Team across direct materials and contract manufacturing that supports the client.
The PBP partners primarily with senior business leaders, generally at the VP level.
The PBP diagnoses and recommends solutions to complex business issues extending across multiple groups and multiple Officer organizations, and on a function-wide level, consistent with business needs and cross-functional business initiatives.
The PBP’s actions, decisions and ability to deliver results significantly affect the credibility of the Procurement function and may have a significant effect on the success of the Officer’s organization.
The PBP will apply their deep and recognized expertise (such as external market knowledge, strategy, influence, communications, category management, etc.), knowledge of the business and environment and situation specific analysis in formulating and implementing strategic solutions consistent with business needs and initiatives.
The PBP will successfully plan, prioritize and lead complex work assignments.
As a member of the Tech Ops Procurement Leadership Team, influence and collaborate with colleagues to create, continuously evaluate and ensure strategic, consistent, business-focused Procurement support aligned with business objectives, consistent with company values and culture and in compliance with laws and regulations.
Who You Are
Qualifications:Education, Experience, Knowledge and Skills:
presence and comfort in working with very senior business people both inside
and outside of Genentech.
to work collaboratively and influence a broad range of constituents
leadership skills and strategic agility
strength in negotiation and resolving issues
leader and manager with track record of recruiting and developing strong
strong business knowledge of Manufacturing Operations, Development, Finance,
Supply Chain, Regulatory & QA, cGMPs and regulatory guidelines.
to travel domestic and international.
B.A. or B.S. degree in Life Sciences, Engineering or
Business; MBA preferred.
15+ years of relevant experience in the pharmaceutical,
biopharmaceutical, devices or related industry or an equivalent combination of
education and experience. CMO, management consulting and/or international
experience a plus
Protein, small molecules or device manufacturing or clinical labeling, packaging and/or,
distribution experience is required.
Demonstrated ability to lead/direct and work in large,
cross-functional, cross-enterprise, and/or multi-cultural project teams.
Strong ability to lead strategic outsourcing, business,
operations and quality decisions at all levels of an organization.
Demonstrated skills in project management, financial
concepts and analysis skills are required.
Strong analytical and creative problem solving skills to
address a broad range of complex problems to support business decisions
Demonstrated skills in building and leading teams,
decision-making, communication, teamwork and collaboration across senior
Subject Matter expert of manufacturing operations, supply
chain management, and processes.
Demonstrated ability to negotiate and develop complex
Effective communicator at all levels; excellent written,
oral and interpersonal communications and presentation skills.
Genentech is an Equal Opportunity Employer with a commitment to diversity. All individuals are encouraged to apply.
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