Product Quality Director – Synthetics
Amgen
full-time
Posted on:
Location Type: Hybrid
Location: California, Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $187,214 - $221,722 per year
Job Level
Lead
About the role
- Champion for a product team as the Product Quality Leader, providing technical expertise, strategic and project leadership to the Product Quality organization.
- Collaborate with PQ staff and executive leadership, International Quality, Quality Control, and other functional areas on the resolution of issues.
- Drive operationally efficient processes and corporate alignment across international sites.
- Provide scientific oversight for product quality of pivotal and/or commercial product(s).
- Lead a Product Quality Team, including oversight of product stability programs.
- Provide effective, cross-functional quality leadership and manage multiple complex long-term PDT deliverables.
- Demonstrate proficiency in oral and written communication of complex information to Amgen leadership and regulatory agencies.
- Actively mentor team members to develop Product Quality core skills.
Requirements
- Bachelor's Degree and 9 years of Quality, Operations, Scientific, or Manufacturing experience OR Master's Degree and 7 years of Quality, Operations, Scientific, or Manufacturing experience OR Doctorate Degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience
- Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field
- Expertise in the areas of drug substance and drug product manufacturing, analytical testing, and industry regulations related to small molecules, peptides and/or oligonucleotides.
- 8+ years of pharmaceutical experience with increasing responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience
- 6+ years working in a regulated environment (direct GMP)
- 4 years experience managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
- 2+ years experience as a technical expert or product champion
- 1+ years of experience with authoring or review of regulatory filing or similar regulatory documentation.
- 1+ years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
- Experience in Project Management in support of product development
- Knowledge of quality, compliance and regulatory requirements
- Knowledge of analytical techniques used for synthetic product quality control
- Understanding of drug substance and drug product development and manufacturing
- Strong leadership and management skills.
- General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals
- Previous experience working on a cross-functional team in a matrix environment
- Excellent written and verbal communication skills, including facilitation and presentation skills.
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality managementanalytical testingdrug substance manufacturingdrug product manufacturingregulatory complianceproject managementnon-conformance investigationcGMPpharmaceutical manufacturingquality control
Soft skills
leadershipmentoringcommunicationcollaborationstrategic thinkingproblem-solvingcross-functional teamworkorganizational skillspresentation skillsfacilitation