Associate Director, Outsourced Manufacturing
Company: GILEAD Sciences
Location: San Mateo
Posted on: June 16, 2022
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Job Description:
Gilead Sciences is continuing to hire for all open roles. Our
interview process may be conducted virtually and some roles will be
asked to temporarily work from home. Over the coming weeks and
months, we will be implementing a phased approach to bringing
employees back to site to ensure the health and safety of our
teams.For Current Gilead Employees and Contractors:Please log onto
your Internal Career Site to apply for this job.Job
DescriptionAssociate Director, Outsourced ManufacturingThe
Associate Director of Outsourced Manufacturing will play a critical
role within the Chemical Development and Manufacturing (CDM)
organization to drive multiple projects at both clinical
development and commercial manufacturing stages. The Associate
Director will ensure delivery of clinical and/or commercial
materials (API drug substance and their intermediates) on time, in
good quality and in full compliance. The Associate Director will
have the opportunities to work with and learn from colleagues
across Gilead (Process Chemistry, Regulatory, Formulations,
Analytical, Quality, Supply Chain, etc), as well as multiple CRO
and CMO organizations. Strong technical skills
(chemistry/engineering, GMP regulation and drug development, etc.)
and business skills (contract negotiation, project management and
financial analysis, etc.) will be called upon and excelled at this
position.With the commitment and drive you bring to the CDM
workplace, you will be part of a team that is changing the world
and helping millions of people live healthier, more fulfilling
lives. You will 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 CDM at Gilead, you will further our mission to
address unmet medical needs and improve life by advancing the care
of patients with life-threatening diseases.Specific
Responsibilities and Skills:Technical Responsibilities:Manages
technical transfer activities to new supplier sites.Contributes to
the development of complex new concepts, techniques and standards
in terms of synthetic routes, process scale-ups, and commercial
launches.Contributes to the creation of analytical specifications
and procedures with long-term project impacts.Develops methods,
techniques, and evaluation criteria to plan and monitor production
of commercial and/or clinical materials.Ensures all related
manufacturing is consistent with appropriate regulations of GMP,
ICH, ISO, or environmental control.Maintains documentation to
reflect the effectiveness and efficiency of production and
department activities.Business Responsibilities:Closely monitors
and manages supply and demand of commercial and/or clinical
materials using advanced planning tools.Collaborates with supply
chain partners in monthly planning and execution activities related
to Logistics.Identifies and purchases custom raw materials,
reagents, and other services necessary for the supplies of drug
substances.Negotiates manufacturing schedules and prices with
external suppliers.Manages logistics activities for outsourced
materials such as warehousing, -transportation, customs clearance,
and invoicing.Frequently interacts with other functional peer group
managers within Gilead and CROs/CMOs to support the development or
manufacturing activities above.Skills:In-depth understanding and
application of pharmaceutical process development and industry
practices.Ability to effectively manage multiple priorities; good
organizational and time management skills.Solid working knowledge
of regulatory guidance, including pharmaceutical GMPs and ICH
Q7A.Strong negotiation skills.Able to develop solutions to a wide
range of complex problems.Exceptional verbal and written
communication skills.Familiarity with the technologies, strengths,
and weaknesses of a wide variety of fine chemical and
pharmaceutical manufacturers worldwide.Ability to interact
effectively with senior management.Knowledge and Experience:10+
years of progressively responsible experience in a related field,
including process development, manufacturing, or outsourcing in the
pharmaceutical industry and a BA or BS degree in Chemistry or
Engineering fields.MA/MBA degree can be substituted for 2 years of
relevant experience.Ph.D. degree can be substituted for 4 years of
relevant experience.For 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 -careers@gilead.com -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
ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY
TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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.SummaryLocation: United States - California - Foster
CityType: Full time
Keywords: GILEAD Sciences, San Mateo , Associate Director, Outsourced Manufacturing, Executive , San Mateo, California
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