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Associate Scientist II
Tech Transfer, Downstream
Confirmed live in the last 24 hours
Locations
Carlsbad, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Requirements
  • 7+ years of relevant experience and a BS degree in a relevant scientific discipline
  • 5+ years of relevant experience and an MS degree in a relevant scientific discipline
  • Demonstrates a strong knowledge of large scale protein purification and Good Manufacturing Practices (GMPs), and can ensure that processing activities are adherent to compliance expectations in both clinical and commercial processing environments
  • Exhibits a good working knowledge of regulatory filing requirements and guidance documents
  • Can serve as a subject matter expert on chromatography and filtration (including tangential flow filtration) operations in cGMP environments
  • Familiar with and capable of implementing single use technologies and systems in cGMP environments
  • Possesses excellent verbal, written, and interpersonal communication skills
  • Demonstrates strong computer, organizational, and project management skills
  • Candidate should be self-motivated, organized, collaborative and a team player
  • Prior experience in MSAT, PD and MFG is preferred
Responsibilities
  • Leads or serves as downstream tech operations representative on cross-functional technical transfer or new product introduction projects both internally and contract manufacturing sites (CMOs)
  • Responsible for initiating and directing the implementation of manufacturing changes on multiple projects across multiple production sites
  • Provides on-the-floor technical support as needed across multiple manufacturing sites
  • Writes impact assessments and supports change control, deviations, and CAPA completion
  • Leads the completion of all downstream technical activities for manufacturing through management of internal and external resources
  • Analyzes and identifies risks with processes, technologies and methods
  • Identifies opportunities to improve processes within the business and provides technical expertise and support to process improvements
  • Monitors process performance by collecting and analyzing process data using statistical tools
  • Supports automation and process validation activities
  • Manages multiple projects/initiatives in parallel
  • May supervise personnel, and act as a mentor to those with less experience and provide training
  • Acts as an effective and committed team member
  • Please note - role will require a minimum of 20% travel, locally and abroad
  • Leads technical support activities related to maintaining clinical and commercial product supplies through management of internal and external resources
  • Contributes to and leads complex projects across functions and interacts effectively with the other team members to ensure product meets regulatory, performance, and cost requirements
  • Contributes to and leads technical investigations of process deviations and assessment of their impact on product quality. Defines requirements for and reviews master batch records
  • Contributes to user requirement specifications and provides expert process technical support to utilize and validate new and improved technologies
  • Liaises with manufacturing groups to deliver new and improved drug products and processes
  • Can lead one or more specific components of departmental strategic initiatives
  • Revises, improves or develops new procedures to support clinical and commercial products; writes protocols and reports
  • Designs and executes bench experiments to support internal manufacturing initiatives or collaborations with external researchers
  • Identifies and introduces new technology and/or methods to the organization, and trains junior staff and/or manufacturing staff on their implementation
  • Provides assessment and selection of equipment and critical materials based upon operational capability and process performance data during scale-up and new process introduction
  • Analyzes and identifies risks with processes, technologies and methods, creates a working plan to prevent potential issues
Gilead Sciences

10,001+ employees

Critical disease biopharmaceutical development
Company Overview
Gilead’s mission is to discover, develop and deliver innovative therapeutics for people with life-threatening diseases. The company is committed to creating a healthier world for everyone through their research, development of forward medicines, and clinical trials.
Benefits
  • Paid family time off and paid parental time off
  • Generous 401(k) contribution matching
  • Comprehensive medical plans that cover both physical and mental healthcare
  • Global Wellbeing Reimbursement
  • Time Off
  • Global Volunteer Day
  • Giving Together Program
  • Employee Support Programs
  • Flexible Work Options
Company Core Values
  • Integrity: Doing What’s Right
  • Inclusion: Encouraging Diversity
  • Teamwork: Working Together
  • Accountability: Taking Personal Responsibility
  • Excellence: Being Your Best