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Director, Program Management (CMC Biologics)

Company: Exelixis
Location: Oakland
Posted on: June 22, 2022

Job Description:

Company Description

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.

As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.

Cancer is our cause. Make it yours, too.

Job Description

The Director, Program Management Biologics CMC drives the overall success of CMC development programs and manufacturing within Pharmaceutical Operations. The individual leads, initiates, and manages the development of detailed project plans on key initiatives, including timelines, identification of tasks, defined milestones, resourcing, and budget planning.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Create, manage, and update timelines to connect across the Biologics CMC stakeholders to help enable large molecule development and manufacturing, and to align with overall project objectives

Oversee and manage the effective coordination and facilitation of team meetings from a program management perspective with a focus on cross-functional integrated CMC activities for molecules in both DC through IND stages, and IND through BLA stages for our Biologics portfolio.

Manage and prioritize support of multiple project teams at one time.

Provide meeting management support, including meeting planning, scheduling, facilitation, documentation (development of meeting agenda and minutes), and outcomes communication.

Monitor key deliverables, decision points, demand planning, and critical path activities to drive delivery.

Proactively manage project risks and mitigation plans; adhere to the team communication plan for escalation when needed.

Oversee the appropriate use of electronic information management tools to prepare and maintain project documents such as working product profiles, integrated project plans, project tracking and status reports.

Collaborate with Department leaders to establish meetings and charters for departmental governance and committee meetings.

Facilitate robust communication within Biologics CMC, pharmaceutical operations, and cross-functional departments to ensure all functions are aware of changes in strategy and impacts to risks and resources.

Ensure team members accountable for on-time completion of tasks or milestones.

Performs critical path analysis and supports scenario planning for manufacturing and supply chain deliverables.

Actively identify areas that may lead the implementation of new processes and systems designed to improve the efficiency and effectiveness of the PSC function.

Supervisory Responsibilities

Supervises staff, including hiring, scheduling and assigning work, reviewing performance, and

recommends salary increases, promotions, transfers, demotions, or terminations.

Education/Experience/Knowledge & Skills

BS/BA in a relevant drug or biological development discipline and a minimum of thirteen years of related experience; or,

MS/MS in a relevant drug or biological development discipline and a minimum of eleven years of related experience; or,

PhD in a relevant drug or biological development discipline and a minimum of eight years of related experience; or,

Equivalent combination of education and training.

Experience

CMC development project management experience in biopharmaceuticals, including working closely with CMC development and manufacturing functions

Experience creating and managing a complex development plan for the entire Biologics CMC scope

Experience managing a portfolio of multiple products, and prioritization of activities and resources.

Experience and prior knowledge of drug development for large molecules.

Experience with biologics across the product life cycle (discovery to licensure)

Knowledge/Skills

Exceptional project management skills

Working knowledge and familiarity with technical areas and manufacturing for CMC biologics

Excellent skills with Microsoft Word, Excel, PowerPoint, Smartsheet, MS Project Professional or other project management tools and digital solutions to manage project scheduling and tracking.

Strong skills in verbal and written communication, meeting management, and presentation.

Solid judgement with the ability to drive problem solving, make decision making, and issue resolution.

Displays persistence and resilience to overcome project obstacles and drive to completion. Energetic, highly organized, detail-oriented, diplomatic and calm under pressure.

Able to deal with uncertainty in a constructive manner and generate options for moving forward.

Applies technical expertise in project management and contributes to the development of new concepts, techniques and standards.

Should be knowledgably about cGMP requirements and quality management systems for the pharmaceutical or biotechnology industry environment.

Working knowledge of drug development process and the Federal laws and regulations affecting the pharmaceutical industry.

Working Conditions

Environment: primarily working indoors in an office environment

Travel required - 20% of time

Additional Information

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Keywords: Exelixis, Oakland , Director, Program Management (CMC Biologics), Executive , Oakland, California

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