Overview
The Sr. Manager, MSAT Protein Sciences Downstream is an experienced manufacturing and processing subject matter expert with a focus on protein sciences and downstream process. The position is responsible for managing Iovance’s GMP manufacturing operations and contracted manufacturing operations centered on protein production and characterization, with a focus on downstream process. S/He will actively collaborate with Process Development, Manufacturing, Quality, Supply Chain, Regulatory, functions, in the US/EU with a focus on ex-US manufacturing operations.
This position will report to Manufacturing Sciences and Technology and involves planning, coordinating, and overseeing contract manufacturing and development services for Iovance products through the product life cycle. Oversight includes process development, transfer, scaleup, validation, improvements (COGS), and studies supporting technical changes/improvements. This position will also provide necessary leadership to support CMC product teams and/or lead subteams, manage technical information/data flows, manage project milestones, support audits, and assist in qualification, validation, and regulatory filing activities. Additionally, this position will be responsible for manufacturing data management for selected clinical/commercial products.
Responsibilities
- Subject matter expert in diverse molecular biology, protein expression, purification and biochemistry. An understanding of analytical methods including microbial methods is preferred.
- 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.
Required Experience
- 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 expression, characterization, and purification. Good understanding of protein expression, QC methods, and/or formulation and drug product processing 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, 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.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required:
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to work on a tablet or computer for 80% of a typical working day.
- Must be able to move and lift 15 pounds.
- Wear proper personal protective equipment when in the warehouse, laboratory setting, i.e., safety glasses, lab coats, and closed-toed shoes.
Mental:
- Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion
- Ability to handle work-related stress
- Ability to handle multiple priorities simultaneously
- Ability to meet deadlines
Work Environment:
- This position will work in both an office and a manufacturing setting.
- Potential exposure to noise, equipment hazards and strong odors
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
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