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Gilead

Sr. Associate II, Outsourced Mfg

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Job Description:

The Sr. Associate II of Outsourced Manufacturing will play an important role within the Chemical Development and Manufacturing (CDM) organization to drive projects to completion, at both clinical development and commercial manufacturing stages and ensure delivery of clinical and/or commercial materials (API drug substance and their intermediates) on time, in acceptable quality and in full compliance. They will also be responsible for financial planning/tracking, contract establishment, work order/purchase order generation, timeline/deliverable monitoring and project management. The Senior Associate I will have the opportunity 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. 

Specific Responsibilities:

  • In collaboration with key stakeholders, manages execution and completion of project deliverables within established timelines and in compliance with legal contracts and agreements
  • Ensures all related manufacturing conforms to the appropriate regulations (GMP, ICH, QA, Regulatory, etc.)
  • Manages technical transfer activities to new supplier sites
  • Negotiates manufacturing schedules and prices with external suppliers
  • Reviews contractor documentation including master batch records, specifications, deviations and change controls for GMP compliance and alignment with Gilead standards
  • Closely monitors and manages supply and demand of commercial and/or clinical materials using advanced planning tools
  • Identifies and purchases custom raw materials, reagents, and other services necessary for the supply of drug substances 
  • 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 CMOs to support process  development or manufacturing activities
  • Organizes and participates in teleconferences and face-to-face meetings with CXOs; works closely with Gilead teams to establish agenda and keep track of key decisions and action items
  • Proactively communicates 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
  • Works on special and non-routine projects focused on risk management, continuous improvement, teamwork/teambuilding, and operational excellence

Skills and Experience:

  • Basic understanding of synthetic chemistry and/or pharmaceutical process development
  • Ability to effectively manage multiple priorities
  • Working knowledge of GMPs and associated regulations
  • Sound organizational and time management skills
  • Exceptional presentation, oral and written communication skills
  • Ability to interact effectively with senior management
  • Ability to collaborate with cross functional teams
  • Ability to work under uncertainty and to resolve conflict in a constructive manner
  • Ability to solve moderately complex problems through ingenuity and collaboration with SMEs and other key stakeholders
  • Ability to work in a fast-paced environment
  • This position may require domestic and international travel time up to 10%
  • 4+ 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
  • A MA/MS/MBA degree can be substituted for 2 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.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.

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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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