Senior Director External Manufacturing, Biologics
Company: Gilead Sciences, Inc.
Location: Oceanside
Posted on: May 14, 2022
Job Description:
Senior Director -External Manufacturing, Biologics- Oceanside,
CAThe Senior Director in Gilead's External Manufacturing
Organization will be responsible for effectively managing contract
manufacturing organizations (CMOs) and contract testing
laboratories (CTLs) for biologics programs from research to
commercial production. An ideal candidate is a highly motivated
individual who will use their business acumen and technical
knowledge to establish and sustain strong external relationships to
drive high performance. The individual must be able to distill
complex problems into concise and clear communication and content
to enable effective decision making. Strong leadership is required
to provide direction and develop teams either through direct
management or matrixed relationships.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:
- Manage external manufacturing and analytical testing of
biologics programs
- Negotiate Confidentiality Agreements, Master Services
Agreements and Work Orders
- Prepare, review and negotiate Request for Proposals (RFPs)
- Lead and participate in solving highly complex problems
- Provide input and recommendations on external investments
- Conduct and document risk assessments and develop appropriate
mitigation strategies
- Coordinate and lead meetings with internal stakeholders and
CMOs documenting discussion points and key decisions
- Develop budgets and accurately report accruals to Finance
- Lead/support business reviews for assigned external
partners
- Ensure accurate and on-time payments to external partners
- Lead and participate in Operational Excellence projects
- Monitor and verify implementation of Gilead's controlled
documents at CMOs and CTLs with Gilead's Contractor Manuals (CMs)
system
- Write, revise and review Standard Operating Procedures
- Effectively manage people and teams directly and indirectlyJob
Functions and Duties:
- Collaborate and maintain regular meetings with key stakeholders
and external partners to ensure external needs are being met
- Evaluate, select and onboard CMOs/CTLs s including site visits,
contract negotiation, initiating GMP audits, applicable Work Orders
and Purchase Orders
- Maintain project timelines and evaluate progress against
established deliverables
- Collaborate with key stakeholders to prioritize activities
according to project needs
- Maintain oversight of financials and project deliverables
associated with external development activities
- Organize and participate in teleconferences and face-to-face
meetings with CMOs working 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
- Maintain and update documentation and timelines to accurately
reflect the status of the external activities
- Function as people manager providing training and coaching,
conducting performance assessments and developing meaningful
development plansKnowledge, Experience and Skills:
- 14+ 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 external 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 25% domestic and international
travelFor jobs in the United States:As an equal opportunity
employer, Gilead Sciences Inc. is committed to a diverse workforce.
Employment decisions regarding recruitment and selection will be
made without discrimination based on race, color, religion,
national origin, gender, age, sexual orientation, physical or
mental disability, genetic information or characteristic, gender
identity and expression, veteran status, or other non-job related
characteristics or other prohibited grounds specified in applicable
federal, state and local laws. In order to ensure reasonable
accommodation for individuals protected by Section 503 of the
Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment
Act of 1974, and Title I of the Americans with Disabilities Act of
1990, applicants who require accommodation in the job application
process may contact for assistance.Following extensive monitoring,
research, consideration of business implications and advice from
internal and external experts, Gilead has made the decision to
require all U.S. employees and contractors to receive the COVID-19
vaccines as a condition of employment. "Full vaccination" is
defined as two weeks after both doses of a two-dose vaccine or two
weeks since a single-dose vaccine has been administered. Anyone
unable to be vaccinated, either because of a sincerely held
religious belief or a medical condition or disability that prevents
them from being vaccinated, can request a reasonable
accommodation.---For more information about equal employment
opportunity protections, please view the 'EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE
FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION
PROVISION Our environment respects individual differences and
recognizes each employee as an integral member of our company. Our
workforce reflects these values and celebrates the individuals who
make up our growing team.Gilead provides a work environment free of
harassment and prohibited conduct. We promote and support
individual differences and diversity of thoughts and opinion.For
Current Gilead Employees and Contractors:Please log onto your
Internal Career Site to apply for this job.
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Keywords: Gilead Sciences, Inc., Oceanside , Senior Director External Manufacturing, Biologics, Executive , Oceanside, California
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