Amgen · 16 hours ago
Director Process Development - Purification Process Engineering
West Greenwich, RI
Full-time
Onsite
Director/Executive
8+ years expAmgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. The Director of Process Development - Purification Process Engineering will lead the purification process engineering function, providing technical guidance and ensuring the successful transfer of processes within a high mix, multiproduct manufacturing facility.
BiotechnologyHealthcareManufacturingPharmaceuticalHealth Care
Responsibilities
Lead the Purification Process Engineering function within Process development organization
Responsible for technical guidance of commercial Drug Substance operations within a high mix, multiproduct manufacturing facility
Technical transfer and scale up of processes, deployment of novel manufacturing technologies and troubleshooting biologics manufacturing processes
Serve as the primary process development point of contact with key leadership partners in Manufacturing and Quality
Ensure that process engineering deliverables including new process introduction; implementation of new technologies; Process Performance Qualification (PPQ) and ongoing monitoring and support of drug substance production are managed and completed
Provide leadership and subject matter expertise in bioprocess purification disciplines including chromatography and filtration operations
Support process scale-up and technology transfer to production facilities
Partner closely with development teams to ensure successful transfer of knowledge to process teams during technical transfers
Lead a successful team committed to finding innovative ways to maximize team engagement and ensure the team reaches its full potential
Lead multi-functional teams to resolve complex technical problems while meeting quality, schedule, and cost objectives
Serve as member of Drug Substance Technology extended leadership team and utilize network thinking and advancing the process development function
Engage with the manufacturing and process development network to assess technology and to improve facility capacity and capability
Qualification
Required
Bachelor's degree and 10 years of Process Development, Engineering or Manufacturing experience OR
Master's degree and 8 years of Process Development, Engineering or Manufacturing experience OR
Doctorate degree and 4 years of Process Development, Engineering or Manufacturing experience
At least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Preferred
MS degree in Chemistry, Biochemistry, Biochemical or Chemical Engineering, or in a technological field
10+ years of experience in pharmaceutical/biopharmaceutical process development or process support and current in Good Manufacturing Practices (cGMP) and global regulatory expectations
Ability in providing scientific and engineering expertise to multi-functional teams in manufacturing, quality and supply chain to advance complex projects to completion and to interface on technical problem resolution
Ability to compile and statistically analyze data, draw appropriate conclusions and make presentations to multi-functional audience and senior management
Detailed understanding of all stages of Process Validation lifecycle in biologics: Process Design, PPQ, Continued Process Verification (CPV)
Understanding of quality attributes of large molecules and protein products and analytical methods for determination of these attributes
Demonstrated skills in leadership, negotiation and managing customer expectations
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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
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