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
Click
here to apply!
|