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.

Send your cv to hr@appliedstemcell.com

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.

Job Description

We are seeking a dynamic and experienced Associate Director / Director Quality and Regulatory Affairs to lead our growing quality and regulatory functions. The successful candidate will be responsible for building and leading a strong QMS, ensuring compliance with regulatory requirements, maintaining audit readiness and interfacing with client quality and technical teams, and driving continuous improvement initiatives across all aspects of our operations.

Key Responsibilities

Quality Management:

• Develop and implement quality management systems (QMS) in accordance with applicable regulations (e.g., FDA, EMA, ICH) and industry best practices.
• Oversee all quality control and quality assurance activities throughout the product or project lifecycle, from early clinical to commercial phase, including supplier qualification and raw material testing, in-process monitoring, and final product release.
• Collaborate with clients on quality and compliance aspects of technology transfer and new product introduction. Serve as an expert resource, internally and with clients, for business and proposal development activities.
• Establish and maintain key performance indicators (KPIs) to track and improve quality metrics for management review, such deviation and CAPA rates, environmental monitoring trending, audit performance, customer complaints, supplier quality, change control, etc.

Regulatory Affairs:

• Serve as the primary liaison to clients’ regulatory teams and ensure timely support of client regulatory CMC filings, including IND/IMPD and associated updates. Develop and maintain Drug Master Files (DMF) for banked cell products and facilities.
• Interpret and communicate regulatory requirements to internal and external stakeholders, providing guidance on compliance strategies and potential regulatory risks.
• Stay abreast of emerging regulations, guidance’s, standards, and industry trends relevant to cell and gene therapy products, and proactively integrate regulatory intelligence into business strategies.

Compliance Oversight:

• Conduct internal audits and oversee external audits from clients, regulatory agencies, and partners, ensuring adherence to cGMP, GTP, and other relevant standards.
• Collaborate with cross-functional teams to address compliance issues, CAPAs, and quality system deficiencies in a timely and effective manner.
• Champion a culture of compliance and quality excellence through training, coaching, and fostering a mindset of continuous improvement.

Risk Management:

• Lead risk assessment activities to identify and mitigate quality and regulatory risks associated with manufacturing processes, supply chain management, and product development.
• Develop risk management plans and ensure proactive risk mitigation strategies are implemented to maintain product quality and regulatory compliance.

Team Leadership/Business Management:

• Recruit, mentor, and develop a high-performing team of quality professionals, fostering a culture of accountability, collaboration, and professional growth.
• Provide strategic direction and leadership to the quality team, empowering them to achieve departmental goals and objectives.
• Develop and manage to an operating budget

Qualifications

• Bachelor’s degree in life sciences, engineering, or related field; advanced scientific degree or MBA preferred.
• Experience in quality assurance, quality control, and regulatory affairs (primarily CMC) within the biotechnology or cell and gene therapy industry, with at least 5 years in a leadership role. GCP and GLP experience is a plus.
• In-depth knowledge of global regulations governing cell and gene therapy products, including FDA and EMA requirements. Understanding of the drug development pathway and phase-appropriate CMC requirements.
• Proven track record of successful regulatory inspections and/or client audits, submissions, and interactions with regulatory agencies.
• Strong leadership and communication skills, with the ability to influence and collaborate effectively across internal and external teams.
• Strategic thinker with a demonstrated ability to develop and implement quality and regulatory strategies aligned with business objectives.

Supervised by:  Chief Operating Officer

Benefits:

• Competitive salary and benefits package
• Opportunities for professional development and career advancement
• Collaborative and highly innovative work environment at the forefront of cell and gene therapy advancements

Job Description

We are seeking an Associate Director / Director Marketing with extensive experience and expertise in our Cell and Gene Therapy (CGT) business.  The ideal candidate for this position is someone who can conduct market and competitor research to gain insight into the industry and analyze data to create effective marketing strategies for our Business Development and Solution Planning units.  Success in targeting addressable market segments will involve the implementation of strategies to strengthen brand awareness, generate highly qualified leads, and provide adequate marketing materials for Business Development.  Our Solution Planning will also utilize developed strategies to support decisions for current or future product and service evaluations.

To thrive in this position, you need to have comprehensive knowledge of the cell therapy and gene therapy fields to align ASC’s services and products with the industry’s demands. This presents a unique opportunity for the Head of Marketing to shape the future of ASC and the industry, sparking inspiration and excitement in potential candidates.

The successful candidate will devote 25% of their time gathering insight from customers and competitors, which they will then share with the organization to encourage internal transformation. The remaining 75% will be focused on developing targeted marketing strategies and deploying and executing efficient marketing channels by working with internal R&D, Operations, Legal, and Commercial teams to enhance business growth.

We are seeking an Associate Director / Director Marketing who is driven and innovative, who can utilize their technical expertise and marketing knowledge to advance our Cell and Gene Therapy Business.

Key Responsibilities

• Lead the effort to gather information about global and regional macroeconomics, customer segments, and C&G industry trends during the strategic annual planning process.
• Perform deep dives into the cell and gene therapy market using secondary and primary research, as well as customer interviews, to provide intelligence strategies to the commercial and technical teams. The findings must address our customer needs, market trends, appropriate pricing strategies, threats, competitions, and opportunities to promote business growth.
• Organize and deliver marketing content or supporting materials for account-based or traditional marketing, with the involvement of operations, R&D, business development, legal, and outside agencies.
• Deploy marketing strategies through proper marketing channels for the best return on investment.
• Manage and execute all tradeshow or conference functions, including booth registrations, speaking arrangements, attendees’ registrations, and all necessary logistics for all chosen events.
• Create press releases and distribute them promptly in accordance with ASC’s business situation.
• Leverage strategic priorities to strengthen current and future products and services portfolios while working with solution planning and development teams to meet yearly booking/revenue goals and stay ahead of the competition.
• Analyze customer pipeline data and purchasing information to discover additional opportunities and offer sales recommendations or training for business development.
• Track, analyze, and report on marketing initiatives and dynamics, including the competitive landscape and emerging technologies, and submit monthly or quarterly KPI or tracking reports to management. Ensure campaign metrics demonstrate the program efficiency of marketing activities and drive the intended demand.
• Develop and manage marketing program budgets, ensuring efficient allocation of resources for maximum ROI
• Monitor and report on budget performance, making recommendations for adjustments as needed.
• In-person working gives us the platform we need to connect, work at a pace and challenge perceptions. We balance the expectation of being in the office while respecting individual flexibility.

Qualifications

• An advanced degree, Ph.D., in biology, immunology, biochemistry, or bio-medical engineering, or a related field.
• A certificate or degree in business or marketing is preferred.
• 2+ years’ experience in the life science or bioprocess industry with a marketing focus on cell therapy/gene therapy and worked with outside marketing agencies.
• 5+ years of experience in marketing and strategic marketing required. Product management, business development, or management consulting experience.
• Demonstrated experience in CGT strategy and marketing development.

Knowledge, Skills and Abilities:  

• Geography: resident in the San Francisco Bay rea.
• Language: Proficient in writing and editing English pieces for the desired marketing purposes.
• Market intelligence expertise: Able to analyze customer, market, and competitor data to extract valuable insights and recommend strategies to fuel growth.
• Strategic marketing and execution: Able to develop and execute multi-channel marketing strategies for a sustainable competitive advantage.
• Vertical marketing experience: Demonstrated success in vertical marketing. Ability to understand customer pain points and needs and frame product offerings into workflow solutions., preferably with an advanced degree and related cell and gene therapy experience.
• Knowledge of CGT technologies: Familiar with cell and gene therapy technologies, processes, competition/industry knowledge, and customer needs, behaviors, and difficulties.
• Strong project management skills: Proficient in managing projects, problem-solving, and prioritizing tasks in a fast-paced environment to improve productivity and efficiency.
• Financial acumen: Understands the financial impact and metrics of marketing to enhance marketing effectiveness to meet business booking/revenue objectives year after year.
• Analytical competence: Skilled in synthesizing data from various sources and communicating key insights effectively.
• Collaboration and matrix management: Able to work in a highly matrixed organization, collaborating with cross-functional teams.
• Influencing skills: Capable of influencing without direct authority.
• Proficient in working collaboratively with various levels of management in a matrix environment.
• Ability to travel up to 10% of the time

Supervised by:              Chief Commercial Officer

Job Description

The Sales Account Manager (AM) is a sales role accountable for representing and selling ASC products and services by maintaining and expanding customer base in academic, governmental and industrial segments. The AM will participate in the development of strategic and tactical plans and execute those plans to meet or exceed sales objectives. The AM will drive the strategy and sales for the region, and overall performance of the respective territory. The AM will participate in national, regional, and local strategic meetings, as well as, lead meetings with their respective team members. The AM will also work cross-functionally to pull through wins from the market team leads and senior management directive in addition to ensuring the delivery of core messages developed by the Marketing Team.

Key Responsibilities

Position Description and Responsibilities:

• Achieve or exceed sales objectives in assigned region.
• Conduct regular field visits and business reviews through client visits to ensure that proper programs and messages are being utilized and to help close sales.
• Responsible for developing new accounts and expand existing accounts.
• Oversee management of key accounts. Ensures a high level of expertise and customer service is delivered to all customers.
• Recommends product lines by identifying new product opportunities, and/or product packaging and service changes; active competitor tracking
• Ensures cooperative and collaborative communication and execution with Sales Director and Chief Commercial Officer
• Responsible for local tradeshow logistic and organization
• Reading professional publications; maintaining professional network
• Responsible for collaborating effectively and mobilizing all appropriate ASC resources.
• Represent ASC vision and quality policy to the scientific communities

Qualifications

• Experienced sales leader
• 2 – 5 years of life science industry or equivalent experience
• Proven track record of success
• Exceptional business acumen
• Start-up or Product launch experience preferred
• Expertise in basic laboratory skills, specifically for applications in molecular cloning, DNA construct, genome editing, SNP genotyping, cell culture, stem cells or iPSC’s

Minimum Education:

• B.S. in Scientific Discipline required, Ph.D preferred

Minimum Experience:

• 2 – 5 years of demonstrated, successful sales experience preferably to life science research or equivalent.

This job description in no way states or implies that these are the only duties to be performed by this employee.  He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor or the management of the company.

Supervised by:          Director Sales

Job Description

Key Responsibilities

• Maintenance of genetically engineered HEK293 cell lines
• Transfection of HEK293 cells
• Enrichment and cryopreservation of HEK293 cell pools
• FACS isolation of HEK293 cells with desired characteristics
• Outgrowth of sorted single-cell clones and pools
• Extraction of genomic DNA
• Genomic PCR
• DNA purification
• Sequence analysis
• Molecular cloning of variant libraries
• Plasmid mini- and midi-preps

Qualifications

• PhD in Genetics, Cellular Biology, or a related field.
• Must have experience with FACS, mammalian cell culture and genetic variant libraries.
• Experience with molecular biology techniques including PCR, DNA isolation, molecular cloning, variant library cloning, and sequence analysis is a plus.
• Good oral and written communication skills and organizational skills.

Job Description

Applied StemCell Inc. seeks a Research Associate II based at company headquarters in Milpitas, CA. Job duties include: Support in vitro and in vivo gene editing applications, including molecular biology and cell work, for research and the development of proprietary therapeutic technologies.  Perform lab experiments on cell culture maintenance, expansion, characterization and banking of iPSC, iPSC-derived cells, MEF and cancer cells, using aseptic techniques. Operate laboratory instruments and equipment, conduct and monitor experiments, collect data and samples, make observations, and calculate and record results. Analyze organic substances. Perform laboratory experiment, including the collection of information and samples, such as blood and animal tissues. Use computers, computer-interfaced equipment, robotics and high-technology industrial applications to perform experiments and examinations. Monitor and observe experiments, recording production and test data for evaluation by research team. Analyze experimental data and interpret results to write reports and summaries of findings. Provide technical support and services for scientists and engineers working on employer’s proprietary genome editing and stem cell technologies. Maintains highly detailed records of the stages of production development of tests and the final results thereof. Input experiment data into databases. Isolate, identify and prepare specimens for examination. Operate and troubleshoot laboratory and field equipment. Monitor laboratory work to ensure compliance with quality standards of ISO, FDA, OSHA, etc. Participate in the research, development, or manufacturing of proprietary gene and cell therapies. Conduct biological, microbiological or biochemical tests and laboratory analyses to evaluate employer’s therapeutic gene editing applications. Ability to perform a diverse range of assays, tests, and studies of non-routine nature. Provide training to new research associates. Position requires a Bachelor’s degree in Biological Sciences, Biotechnology, Biochemistry, Neuroscience, or a closely-related field, plus at least 6 months of relevant experience working with laboratory equipment, supporting experiments on therapeutic gene editing applications. Send resume to L. Gu, Director, Applied StemCell Inc., 521 Cottonwood Dr Suite 111, Milpitas, CA 95035.