Director –External Manufacturing, Morris Plains
The Director in Gilead's External Manufacturing organization will be responsible for managing contract manufacturing organizations (CMOs) We are seeking a high energy "go- getter" who will use their business savvy and technical experience to help drive high performance from our partners. You will have responsibility for leading people (directly and indirectly), bidding, selecting and managing multiple outsourced programs. This position will be based in our Morris Plans, NJ office and be eligible for the Gilead GFlex program allowing remote work up to 3 days a week.
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.Main Responsibilities
Job Functions and Duties:
- Actively manage outsourced biologics development, manufacturing and testing
- Negotiate Confidentiality Agreements, Master Services Agreements and Work Orders
- Prepare, review and challenge request for proposals
- Ensure accurate and on-time payments to our partners
- Lead and participate in Operational Excellence projects
- Monitor and verify implementation of Gilead's controlled documents at Contract Manufacturing Organizations (CMOs) with Gilead's Contractor Manuals (CMs) system
- Coordinate/lead meetings internally and with CMOs, publishes meeting minutes
- Write, revise and review Standard Operating Procedures
- Provide leadership and training to other department personnel
- Develop budgets and accurately report accruals to Finance
- Lead/support business reviews for assigned partners
- Participates in solving issues of high complexity
- Communicates issues to line manager and project teams in a timely manner
Knowledge, Experience and Skills:
- Collaborate and establish regular meetings with key stakeholders and partners to ensure outsourced needs are met
- Lead Business Reviews with CMOs.
- Evaluate and onboard CMOs including site visits, contract negotiating, initiating GMP audits, applicable Work Orders and Purchase Orders
- Maintain outsourced project timelines and evaluate progress against established dates
- Collaborate with key stakeholders to prioritize activities according to project needs
- Maintain oversight of financials and project deliverables associated with outsourced development activities
- Organize and participate in teleconferences and face-to-face meetings with Global CMOs; work closely with Gilead teams to establish agenda and keep track of key decisions
- Proactively communicate issues, project changes to key stakeholders and facilitates timely discussion and resolution
- Maintains and updates documentation and timelines to accurately reflect the status of the outsourced activities
- Manage outsourcing staff including training, coaching and doing performance assessments
12+ years of experience in a pharmaceutical/biotech organization or relevant manufacturing environment and a BA or BS degree; an MA/MBA degree may be considered as 2 years of relevant experience and Ph.D. may be consider as 4 years' experience.
- Prior experience leading biologics and/or sterile outsourced development and manufacturing
- Strong computer skills and experience with an ERP system and project management software
- Extensive understanding of activities related to the CMC development of biopharmaceuticals
- Advanced knowledge of GMPs and associated regulations (21CFR parts 11, 210, 211, 820)
- Ability to lead cross functional teams
- Strong people management skills
- Extensive experience negotiating complex agreements
- Strong verbal and written communication skills
- Ability to manage multiple programs/projects; sound organizational and time management skills is essential
- Ability to develop concise presentations to convey complex issues to senior management
- Ability to work under uncertainty and to resolve conflict in a constructive manner
- Ability to solve highly complex problems through ingenuity and collaboration with subject matter experts and other key stakeholders
- Ability to work in a fast-paced environment is essential
- Project management experience and/or certification are a plus
- This position may require up to 20% domestic and international travel
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