Facebook pixel

Sr. Manager
Commercial Biologics Analytical Operations
Confirmed live in the last 24 hours
Oceanside, CA, USA • Morristown, NJ, USA
Experience Level
Desired Skills
  • 0+ years of relevant experience and a PhD in a relevant scientific discipline OR
  • 6+ years of relevant experience and an MS in a relevant scientific discipline OR
  • 8+ years of relevant experience and a BS in a relevant scientific discipline
  • Strong understanding and extensive hands‐on experience in analytical development, method transfers and method validations. Deep understanding of product quality attributes control strategies as applied to biopharmaceutical processes. Expert understanding and hands-on experience of methods within the following platforms: chromatography, capillary techniques, ELISA techniques, and compendia assays supporting biologics manufacturing
  • Strong knowledge of cGMP requirements for clinical and commercial testing & manufacturing, and experience working with external manufacturing and testing organizations
  • In-depth knowledge of industry best practices & trends. Familiarity in forensic investigations in support of manufacturing of biologics. Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical operations. Proven experience in the generation of relevant regulatory sections of IND, BLA and MAA filings
  • Demonstrated success working with diverse team members in a dynamic, cross‐ functional environment. Proactively identifies issues and provides solutions through solid problem-solving skills
  • Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation and scientific writing skills. Strong self-awareness of the impact communication and working style has on others. Exceptional influencing, partnership, and collaboration skills and ability to drive results within a matrix environment
  • Support multiple, complex long- term portfolio deliverables for late phase and commercial programs, including method validations & transfers, in process controls, reference standard & specification strategies, comparability & stability strategies, importation testing & network testing strategies. Support investigations change controls as needed. Ensure that all deliverables meet the highest scientific, regulatory, quality, and commercial standards
  • Support implementation of phase-appropriate strategies, business processes, systems, and practices for efficient achievement of analytical deliverables in accordance with cGMP and ICH guidelines and industry best practices. Support the commercial testing network ensuring effective information flow, timeline execution, issue resolution, and documentation in accordance with governing quality system requirements while leveraging robust risk management practices
  • Provide technical support for new product introductions, lifecycle management, investigations, troubleshooting and writing/review of technical reports. Must stay current with relevant technologies and demonstrate forward thinking. Strong planning and resource management skills in a dynamic environment located across multiple geographies
  • Review and summarize analytical data (including stability data) from CTLs/CROs/CMOs, conduct trend analysis, provide feedback and recommendation in assisting the timely resolution of technical and/or quality issues
  • Maintain strong relationships with internal/external stakeholders. Collaborate with Quality Control, Drug Substance/Drug Product Technical Operations, Quality Assurance, External Manufacturing and CTLs, Regulatory CMC, Process Development, and other functional areas. Communicate across cross-functional / cross site teams to facilitate ensure timelines, deliverables, and business operations are aligned and met
  • Support Commercial Biologics AO during external and internal regulatory inspections/audits. Participate in writing, reviewing and approving CMC sections of US and international clinical trial applications, regulatory question responses, supplemental biologics license applications and international variations
  • Travel may be required in support of transfers/performance management of CTLs
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.
  • 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