Applied StemCell Inc. (ASC) is a fast-growing biotechnology company headquartered in the San Francisco Bay area, California. Our goal is to advance gene-editing and stem cell innovation for biomedical research and gene and cell therapy. We are striving to improve and expand our technologies and product lines to bring gene and cell therapy to patients.
We pride ourselves on having an inclusive diverse workforce, with employees from all over the world that bring unique perspectives to our collaborative environment. We deeply value employee ideas and believe in fostering employee growth and development. As a start-up, we are a fast-growing, quick-paced company that provides a strong learning environment for employees to develop critical skills and industrial knowledge.
Our culture is fun, innovative and challenging! For someone to be successful at our company, we need an individual that has the initiative to drive results, can adapt to a fast-changing environment, understands the needs of teamwork, and has the communication skills to confidently share ideas and viewpoints at all different levels within the company.
Benefits at a Glance:
ASC provides the following competitive benefits:
- 100% cover medical, dental, Vision
- Competitive Salary
- Company Paid time off, sick leave, and holidays
- Retirement savings plan – 401K plan
- Short/Long term disability plans, voluntary life insurance, and company-paid life insurance
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.
Quality and Document Control Associate
This position is responsible for the execution, maintenance, and improvement of the quality system, document management, and ISO/GMP training programs related to stem cell production. The person in this position will serve as the site coordinator for Product Quality, Document Control, ISO 13485 audit, and Training systems. The person will demonstrate effective teamwork by developing strong relationships with peers and management through effective oral and written communication.
Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements. Manage and maintain the official Document Change management system for creation, revision, and control of GMP documents. Create and maintain a database to track the status of documents. Responsible for control and maintenance of the QA Documentation file room.
- Generate and review site-specific GMP-associated documents as required to support the production function. Maintains master documents and records for GMP lab (both hardcopy and electronic) as required by applicable regulations such that required documentation is retrievable and files are accurate, complete, and well organized.
- Conduct periodic document audits and assist with internal audits of the Quality Assurance (QA) and/or document management functions.
- Prepare and provide documentation as required ISO audits
- Implements and maintains the training program for employees. Develops and delivers quality training programs for staff to achieve a high level of performance in their jobs and ensure effective training content for newly updated processes and procedures. Ensure that all document training is carried out as required.
- Manage reviews, releases, and control of updates to internal and customer’s specifications for compliance with SOP, manufacturing, and packaging processes and current Good Documentation Practices
- Collaborate with customers to ensure timely implementation of changes to the SOP and training records acquisition from collaborators
- Develop and maintain a comprehensive filing system and computer database for all retention and archival of documents.
- Other QA duties as assigned to facilitate ongoing production and/or operational activities
Education and Experience:
- Bachelor's degree in biological/life sciences preferred;
- Document control/training experience in the pharmaceutical/biotech industry or equivalent combination preferred.
- Technical Knowledge/Skills/Abilities Required:
- Knowledge of GMP related Quality Systems
- Strong attention to detail as demonstrated through the consistent quality of work
- Excellent written and verbal communication skills
- Computer proficiency in MS Word and Excel, Lotus Notes, MS Access required; previous administrative experience in electronic learning management systems preferred
- Demonstrates process orientation thinks through required steps and sequencing to ensure quality work output
- Ability to anticipate potential problems and take proactive action to avoid/minimize the impact
- Anticipates consequences of actions and how they impact other areas
- Ability to independently prioritize, plan and schedule workflow
- Timely follow up to ensure a satisfactory resolution to issues
- Knowledge of cGMPs (relevant laws, guidance, directives, and industry practice), and demonstrated ability to apply learnings appropriately
- Ability to work and coordinate activities across multiple functional groups with a sense of professionalism and urgency
- Self-motivated; able to work with minimal supervision
- Ability to work in a controlled environment
- Excellent Organizational skills, attendance, and reliability required
Sales Associate/ Account Manager
Summary: This position is responsible for representing and selling our products and services by maintaining and expanding the customer base in the academic, governmental, and industrial segments.
Location: Milpitas, CA
Education and Experience:
Education: B.S. in Scientific Discipline required, M.S. preferred
Sales Experience: 0 - 2 years (Sales Associate position) or 2 - 4 years (Sales Account Manager) of demonstrated, successful sales experience preferably to life science research and industrial customers is required. Ability to work independently and handle multiple projects simultaneously. Develops and manages a sales plan and strategy for assigned accounts and territory. Can multi-task in a demanding environment. The ability to understand the science behind our products/services and uses. Basic laboratory experience is a must, specifically for the applications in molecular cloning, genome editing, cell culture, stem cells / iPSCs, immune-oncology, animal modeling, and GMP/GLP process.
- Achieves regional sales operational objectives by contributing regional sales information and recommendations to strategic plans and reviews; preparing and completing action plans; determining regional sales system improvements; implementing change.
- Meets regional sales revenue goals by forecasting and prioritizing leads.
- Maintains and expands customer base; building and maintaining rapport with key customers; identifying new customer opportunities.
- Recommends product lines by identifying new product opportunities, and/or product, packaging, and service changes; tracking competitors.
- Reading professional publications; maintaining personal networks.
- Responsible for local tradeshow logistic and organization
- Need to represent the vision and quality policy of our company to the scientific communities
- Highly self-motivated and capable of managing a large geographical territory
- Experience with iPSC and gene editing is an additional plus
- Strong analytical, communication, interpersonal and organizational skills required
- Experienced with Customer Record Management tool