Prin Site Mgr Contract Mfg

Genentech   •  

San Francisco, CA

Industry: Business Services

  •  

8 - 10 years

Posted 393 days ago

The Position

Position Purpose:

  • Establish strategy and lead the selection, implementation and management of clinical contract manufacturing organizations (CMOs) that are needed to meet clinical supply requirements for drug substance (DS) and drug product (DP)
  • Collaborate with internal functions to assure alignment within Genentech/Roche on internal needs and collaborate with external counterparts to ensure alignment with development and commercial partners
  • Support development and management of supply contracts and the associated supply relationship with development and commercial partners; lead joint teams with partners for supply contracts
  • Develop solutions to complex issues with inter-organizational impact
  • Establish and maintain alignment between Genentech’s goals and objectives
  • Lead and collaborate with cross-functional teams of subject matter experts to achieve business, operations, and quality objectives, plans, and performance goals for the contract manufacturing or business partnerships
  • Serves as consultant to senior management and internal spokesperson for the organization on matters pertaining to policies, processes, and work practices

Responsibilities:

  • Develop and utilize robust processes for the identification, evaluation, and management of third party contract manufacturers
  • Lead cross functional Due Diligence teams in assessing CMOs
  • Collaborate with Legal to negotiate a Master Service Agreement (MSA) with the CMO or partner
  • Lead cross-functional teams in evaluating and selecting CMOs for a particular project
  • Prepare a Statement of Work (SOW). The preparation of an SOW can include negotiation of project fees, negotiation of milestones, defining responsibilities between Genentech and the CMO and keeping Legal, Manufacturing Collaborations Management and other groups up to date on SOW progress
  • Act as primary contact for all business collaborations ensuring that the overall relationship between Genentech and the CMO/partner is healthy
  • Drive continuous improvement of the business relationship including improvement of contracts
  • Lead and manage visits and contact by GNE functions to CMO’s
  • Maintain the Master Service Agreement so that it accurately reflects the existing business relationship. Lead the negotiation and revision effort when changes are required
  • Periodically report on performance and operations at CMO OU Operations Reviews
  • Proactively identify risks. Create strategies to avoid or minimize their impact. Manage the execution of risk mitigation plans
  • Participate in and contribute to drug development telecons in an effort to proactively intercede if a relationship issue jeopardizes the project
  • Create purchase orders. Review and approve invoices for GNE payment and coordinate on-time CMO payments. Develop annual CMO budget (expense and capital) and monitor performance against plan on an ongoing basis
  • Generate and distribute reports for overall site metrics, key issues, production status and highlights, and monthly and biannual performance summaries
  • Follow company policies and procedures
  • Set personal performance goals and provide input to departmental objectives
  • Establish work priorities to meet targets and timelines
  • Manage competing priorities and allocate, adjust, and optimize assigned department resources
  • Identify, design, and implement process and system improvements
  • Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems
  • Troubleshoot and direct the resolution of Collaboration issues by fostering effective interdepartmental and cross-functional partnerships
  • Serve as a technical subject matter expert (SME) in support of department functions.
  • Mentor junior personnel serving as a subject matter expert (SME) on Manufacturing Collaborations systems, processes and issues
  • Collaborate and author department policies and procedures
  • Make decisions that impact the goals and objectives of the department
  • Notify Management of potential business issues that may affect project timelines
  • Drives and contributes to the development of new processes and standards. Drives continuous improvement activities both internally and at CMOs
  • Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions
  • Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies
  • International and domestic travel may reach 25%

Incumbent Specific Responsibilities:

  • CMO SELECTION: Lead and drive the selection process for selecting Clinical and Commercial CMO’s
  • DS/DP Supply: Ensure reliable supplies of DS and DP to our customers and our patients, while meeting acceptable quality standards and Genentech’s financial and development goals. Proactively intercede if goals and timelines are jeopardized
  • Project Kickoff Meetings: Introduce key contacts between Genentech and the CMO’s followed by setting up project kick-off meetings
  • Compliance: Participate in Genentech’s corporate Compliance group’s audit process from planning through implementation, result evaluation, and CMO response review. Support inspection readiness activities as required. Drive the close out of audit commitments and CAPA’S

Quality Agreements: Support External QA in establishing QA agreements with all CMO’s and assuring that Product Specific Requirements (PSR’s) are establishedbeforeprojects are initiated

Who You Are

Requirements:

  • Collaborative Leadership - Ability to strongly influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment. High tolerance for ambiguity, able to create order from chaos
  • Ownership and Accountability – Takes accountability for actions, drives results, learns from mistakes. Is direct and truthful and therefore widely trusted – delivers on promises, goals, and expectations. Makes quality decisions and resolves problems rapidly
  • Communication - Ability to communicate effectively at all levels of the organization, teach and present complex and/or new ideas with clarity and simplicity
  • Planning/Organization - Excellent planning and prioritization skills with the ability to multitask and adapt. Able to synthesize large amount of information. Able to deliver results despite shifting environment. Operate with a high degree of autonomy
  • Analytical Problem Solving – Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes. Innovative and effective in solution development, risk mitigation, and execution
  • Quality-Is customer focused. Able to mentor team members on quality improvement methodologies (Deming, Juran, Crosby) as appropriate to the situation. Uses quantitative approach (SPC, Six Sigma, Lean/DMAIC, etc.)

Education & Experience:

  • B.S. Life Sciences, Business or Engineering. MBA preferred
  • 12+ years or more experience in biotech/pharma industry
  • Small molecule manufacturing experience, especially drug product, is essential
  • Demonstrated ability to lead/direct a team
  • Demonstrated financial and project management skills
  • Collaboration/Influence Management, Decision Making, Leadership and Results Orientation
  • Ability to work effectively with cross-functional & multi location teams
  • Excellent contract negotiation / contract administration skills
  • Demonstrated track record of integrity and ability to instill confidence in colleagues and teams
  • Ability to learn quickly in unfamiliar territory and under minimal managerial training
  • Demonstrated ability to operate independently under general management direction and make sound decisions and be accountable for those decisions
  • Successful track record in execution and completion of deliverables. Changes in plans and updates are proactively communicated to management and teams
  • Strong analytical and creative problem solving skills
  • Strong quality orientation with attention to detail

Job ID: 3107520215