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Project Description: Expert Consultation for Rare Disease Human Stem Cell Therapy Program
Overview:
Our client is spearheading a new initiative within its rare disease portfolio, specifically focusing on human stem cell (HSC) therapy for an ultra-rare pediatric disease. This program is both highly specialized and fast-paced, requiring expert input to optimize its development, manufacturing, and regulatory strategies. The therapy, partially developed and acquired from an external program, is being advanced toward final registration and launch, with a focus on improving processes and addressing potential risks.
Our client has extensive expertise in T cell therapies but seeks guidance from an HSC therapy expert to ensure the program’s success.
Objective:
Identify and engage an expert in human stem cell therapy to provide strategic, part-time consultation for the program’s early-stage milestones. The consultant will contribute by reviewing existing processes, identifying areas for optimization, and assisting the team in achieving key deliverables, such as IND amendments and manufacturing process improvements.
Key Responsibilities:
- Process Optimization:
- Evaluate the partially developed HSC therapy program and identify potential red flags or improvement opportunities.
- Develop a detailed plan for process enhancements in the first three months of engagement.
- Provide strategic guidance on manufacturing processes to align with regulatory requirements and ensure scalability.
- Regulatory Input:
- Support the team in preparing for an IND amendment submission within the next six months.
- Offer expertise to refine protocols and ensure compliance with FDA and other regulatory standards.
- Collaboration & Strategic Support:
- Work closely with Technical Project Lead and Process Development Lead to guide process improvements and strategic initiatives.
- Serve as a resource for manufacturing-related decision-making, leveraging extensive HSC therapy knowledge.
- Maintain an advisory role, contributing protocols and insights on a part-time, flexible basis.
Requirements:
- Proven expertise in human stem cell therapy, with a preference for candidates who also have rare disease experience.
- Strong understanding of manufacturing processes and regulatory considerations for HSC therapies.
- Experience supporting fast-paced, milestone-driven programs, particularly in the biotech/pharma space.
- Ability to provide strategic, high-level guidance while collaborating effectively with internal teams.
Timeline:
The engagement will focus on the first quarter of 2025, with particular emphasis on the initial three months:
- Phase 1 (First 3 Months):
- Conduct a comprehensive review of the current program.
- Draft a detailed process improvement plan.
- Phase 2 (Next 3 Months):
- Transition into the execution phase, with delegated activities.
Engagement Details:
- Part-time, flexible role (strategic consulting capacity).
- Initial contract duration: 6 months, with potential for extension based on program needs.
Outcome:
The consultant’s contributions will help our client streamline the development and manufacturing process for this HSC therapy, paving the way for a successful program launch and eventual treatment availability for pediatric patients in the U.S.
HSC Process Improvement Expert East Hanover, New Jersey
For over 16 years, Medasource has established and maintained relationships that are designed to meet your IT staffing needs. Whether it’s contract, contract-to-hire, or permanent placement work, we customise our search based upon your company’s unique initiatives, culture and technologies. With our national team of recruiters placed at 21 major hubs around the nation Medasource finds the people best-suited for your business. When you work with us, we work with you. That’s the Medasource promise.
Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
Benefits & Perks:
Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
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