Group Leader, Product Development & Production

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Benefits at a Glance:

ASC provides the following competitive benefits:

• Competitive Salary
• Retirement savings plan – 401K plan
• Short/Long term disability plans, voluntary life insurance, and company-paid life insurance
• Company Paid time off, sick leave, and holidays
• 100% cover medical, dental, Vision

Applied StemCell is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Location: Milpitas, CA

Summary:

We are looking for an experienced Group Leader with strong people management skills and in-depth scientific background in stem cell, genome editing technologies to lead the Product/Production team consisting of research scientists, research associates, and quality personnel. Experience with quality systems such as ISO and GMP is preferred.

This individual will be a key member driving operational excellence in development of new iPSC products (working closely with the R&D group), launching products and routine production for worldwide distribution. The Group Leader will support the sales and marketing team in pre-sale as well as post-sales delivery of products. The person will work very closely with cross-functional teams of the company including R&D, Sales, Marketing, Project Management, Quality Assurance to implement and streamline processes, troubleshoot technical issues, launch new product, provide technical training, sales support, and increase company revenue. The person will also lead GMP manufacturing efforts in iPSC related products, including SOP, QC/QA, document control, GMP compliance, etc.

Education and Experience:

• Knowledge of current marketing and advertising trends and best practices in the stem cell and gene editing Life Science industry.
• Fast learner and adaptive in science, technology and IT systems. Using IT system tools to track team progress and report goals.
• Excellent communication skills, both verbal and written and ability to interface effectively with scientist, regulatory, sales, marketing and executive management.
• Strong interpersonal skills. Must be able to mentor others and resolve conflicts.
• High emotional intelligence, sound temperament and professional attitude. Good common sense and judgement. Broad business perspective to integrate CRO/CMO concepts as part of the overall corporate strategy.
• MS or Ph.D. in Stem Cell, Molecular Biology, Immunology, Chemistry or related science with 2+ years of biopharma process development, manufacturing and CRO experience or equivalent.
• Knowledge of Microsoft Office software suite, QuickBooks, Fishbowl and/or other ERP and LIMS data management systems
• Highly self-motivated with ability to build efficient cross-functional teams.
• Assertive, take-charge, proven manager, team player with strong results orientation, positive “can do” attitude and a sense of urgency to get things done.
• Good conceptual, strategic, analytical, problem solving and organizational skills.
• Demonstrated knowledge of cGMP and experience with clinical or commercial manufacturing, testing and characterization of cell and gene therapy product a plus.
• 2+ years of management experience leading production/manufacturing and deep technical knowledge of process development, analytical characterization, quality control, supply chain activities of cell, genome editing or gene therapy products, CRISPR-Cas9, gRNA, mRNA, viral vectors or other complex biologics.
• Good understanding of Quality Assurance and Quality Management Systems (QMS) to ensure adherence to ISO 13485, ISO 9001, GLP, cGMP and SOP.
• Proven management experience in Life Science industry preferably in one or more of the following areas: iPSC/ESC, genome editing, functional genomics, iPSC product development.

Responsibilities:

• Support Sales and Project Manager in delivery of customer-facing presentations covering a variety of scientific research topics, products, applications and data related to ASC core service and products.
• Read professional publications and do research to stay up to date on current technical development in the areas of universal iPSC applications, gene editing, and stem cell research.
• Perform other related duties as assigned.
• Manage and perform manufacturing, QC testing, lot release and distribution activities of products.
• Develop plan and coordinate manufacturing of starting materials to support commercial launch of new and existing products.
• Perform new product development activities, including bench work, planning, budgeting, etc.
• Ensure team readiness of CMO operations, support and lead process validation activities.
• Apply technical and management expertise to meet project goals and timelines and to make technical and management decision to keep projects on track.
• Provide day-to-day oversight of product manufacturing timelines and deliverables including technical transfer and process improvements.
• Develop and ensure the delivery of quality documentation to meet ISO 13485 and cGMP global regulatory expectations.