Senior Manager, Protein Sciences, Downstream
Iovance Biotherapeutics, Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
About the role
- Subject matter expert in protein purification, drug product formulation, fill, and lyophilization.
- Manage and/or support knowledge management (including product, process, and analytical)
- Manage and/or support process, analytical, microbial control strategy development and implementation, and risk assessment and mitigation.
- Build and support long term business relationships with key Contract Manufacturing Organizations in support of flexible and efficient supply chains.
- Manage and/or support technical transfer and technical/COGS improvement projects. Ensure effective stakeholder engagement and ensure on-time and in-budget delivery.
- Support regulatory CMC and registrational activities for clinical/commercial products as required, with a focus on ex-US.
- Liaise with Quality/Supply Chain on product disposition and ensure continuous alignment with quality/supply chain systems requirements. Support technical investigations, deviations and CAPAs as required. Support and participate in site audits, as required.
- Manage and/or support hiring and development of staff, as required.
- Ensure CMO site operational readiness for manufacturing campaigns/process transfer/change controls/validations; including facilities, equipment, documentation, training.
- Utilize strong operational excellence / lean principles, business acumen, quality-mindedness, and excellent communication skills to develop streamlined, efficient, and robust systems.
Requirements
- A minimum of 9 years of related experience with a Bachelor's degree; or 7 years and a Master's degree; or a PhD with 4 years experience in a relevant Life Science discipline or equivalent in work experience.
- In-depth understanding of protein purification, characterization, drug product formulation, fill and lyophilization. Good understanding of protein expression, cell culture processing, and QC methods is a plus.
- Strong prior operational experience preferably in a direct role in a GMP manufacturing environment, with interfaces to Supply Chain, Quality and Regulatory functions, with commensurate experience supporting internationally licensed products.
- Direct experience managing contract development/manufacturing organizations (CDMOs), with focus on aseptic operations and commercial manufacturing, is preferred.
- Must possess a thorough understanding of biotherapeutics manufacturing.
- Demonstrated business and commercial focus with awareness of customer/patient-centric issues.
- Experience working in a global business environment across multiple time zones.
- Self-starter, possessing strong verbal and written communication skills.
- Ability/willingness to travel globally for extended periods, based on business needs.
Benefits
- Reasonable accommodations available upon request
- Diverse and inclusive work environment
- Equal opportunity employer
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
protein purificationdrug product formulationlyophilizationmicrobial control strategyrisk assessmenttechnical transferGMP manufacturingbiotherapeutics manufacturingQC methodsaseptic operations
Soft Skills
communication skillsbusiness acumenoperational excellencestakeholder engagementself-startercustomer-centric focusteam managementrelationship buildingproblem-solvingadaptability