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.
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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.
1. Manager/Sr. Manager, QC
Applied StemCell, Inc. (ASC) is a leading gene editing and cell therapy CRO/CDMO company founded in 2008 in Milpitas, California. ASC supports gene editing and stem cell therapy development processes with two high-impact platforms: CRISPR and TARGATT™ genome editing and iPSC technologies. ASC’s proprietary TARGATT™ technology enables site-specific, stable integration of large DNA fragments into a safe harbor locus. ASC is also a member of the FDA/National Institute of Technology and Standards (NIST) Genome Editing Consortium where we provide benchmark materials using our unique expertise in stem cell technology and genetic engineering to establish measurements and standards for characterizing genome editing outputs using stem cells. Further, our stem cell technology together with genome editing technology and cGMP production capability allows us to be at the forefront of new therapeutic cell line development, an emerging area in the Cell and Gene Therapy (CGT) field.
We are searching for a highly skilled QC Manager to join our Quality team with a focus on building and leading effective and compliant QC operations in cell and molecular biological assays and QC microbiology for sterile products.
The QC Manager will be responsible for providing oversight for the GMP testing of cell therapy products and critical intermediates, leading out of specification (OOS) and environmental monitoring excursion investigations, and refining and maturing QC and cross-functional cGMP workflows. This position will also support client and internal audits and regulatory inspections by providing confident subject matter expertise. The successful candidate will be an experienced people-leader with a proven track record in biologics or cell therapy QC, who can operate in a collaborative, fast paced environment, multidisciplinary environment.
Skills and Experience
- 6+ years of relevant experience in GMP quality control, or a combination of related fields such as analytical development or quality assurance and a BS or BA in a relevant discipline; or 4+ years of relevant experience and a MA/MS/MBA. At least 2 years of experience leading or managing personnel. Sr. Manager title may be considered for candidates who significantly exceed the above requirements.
- Prior experience related to method development/qualification/validation required.
- Knowledge of global regulatory requirements, guidance documents, and best practices for biopharmaceuticals and advanced therapies. Experienced in the application of these in QC operations
- Experience and knowledge of environmental monitoring programs, including ISO 14644 and EU Annex 1
- Experience with flow cytometry, biological assays, and cell therapies is strongly preferred
- Experience with standard microbiological safety testing for aseptically manufactured parenteral products, e.g. sterility per USP <71> or rapid methods, endotoxin, and mycoplasma
- Experience with implementation and use of LIMS and other quality management system software is a plus; experience with implementing, improving and ensuring robust documentation and data integrity approaches
- Experience in preparing for and participating in quality and regulatory audits
- Experience with risk management and qualification of raw materials and vendors/contract service providers
- Strong organizational and multi-tasking skills, attention to detail, and the ability to adapt to changing priorities
- Ability to quickly identify and elevate issues, evaluate impacts, support solutions, and manage change implementation. Experience with GMP change control/change management processes
- Excellent oral and written communications skills and a collaborative personality. Excels in a team-oriented environment
- Testing & Analysis: Lead and manage routine and non-routine analysis of samples (raw materials, in-process and finished goods, stability, etc.).
- Data & Specifications: Review and approve data to ensure accuracy, and compliance. Collaborate on establishing and justifying specifications.
- Procedures & Methods: Create, review, and approve new or revised test methods, SOPs, and qualification/validation protocols and reports. Continuously improve and mature the QC function to phase-appropriate standards.
- Investigations & Deviations: Conduct investigations of out-of-specifications results and manage deviations/CAPA related to analytical procedures.
- Team Building and Training: Grow the QC team and manage QC analyst training: Training need, Design, Delivery, Assessment, Qualification, and Documentation.
- Equipment: Establish the user requirements and qualification of new and existing equipment; manage instrument qualification; develop SOPs for operation and maintenance; troubleshoot as needed.
- Quality Functions: Ensure all QC lab operations and practices meet GxP standards and safety regulations. Participate in internal and client audits and regulatory inspections, support quality systems like Change Control, Deviations, CAPA, Audits, and Quality Metrics.
- Collaboration: Serve as QC representative and subject matter expert within the company, with vendors, and during client interactions.
- Additional Duties: Participate in backups/reviews, manage stability and retain sample programs, support data packages for regulatory submissions, apply scientific knowledge to solve problems, contribute to material inventory tracking, and handle other duties as assigned.
2. Scientist - Cell Biology Group
Applied StemCell, Inc. (ASC) is a leading gene editing and cell therapy CRO/CDMO company founded in 2008 in Milpitas, California. ASC supports gene editing and stem cell therapy development processes with two high-impact platforms: CRISPR and TARGATT™ genome editing and iPSC technologies. ASC’s proprietary TARGATT™ technology enables site-specific, stable integration of large DNA fragments into a safe harbor locus. ASC is also a member of the FDA/National Institute of Technology and Standards (NIST) Genome Editing Consortium where we provide benchmark materials using our unique expertise in stem cell technology and genetic engineering to establish measurements and standards for characterizing genome editing outputs using stem cells. Further, our stem cell technology together with genome editing technology and cGMP production capability allowsus to be at the forefront of new therapeutic cell line development, an emerging area in the Cell and Gene Therapy (CGT) field.
We are searching for a highly skilled Cell Biologist to join our iPSC group with a focus on human iPSC work and its downstream applications.
Skills and Experience
- PhD degree in biological sciences such as cell biology, developmental biology, genetics or related fields.
- At least 1 year rigorous experience with iPSCs and/or other stem cell culture, cell transfection, lentiviral transduction, as well as IPSC reprogramming, etc.
- Hands-on experience for cell differentiation and/or 3D organoid from iPSCs is preferred.
- Working experience in GMP and cleanroom environments are also highly desired.
- Effectively document activities according to procedures; improve procedures through collaborative approval workflows when needs arise.
- Working knowledge and hands-on experience with genome engineering technology (e.g. CRISPR, TALEN or transgenesis) is a plus.
- Require high degree of attention to detail.
- Understanding of US FDA cGMP and international regulatory requirements is welcomed.
- Good oral and written communication and organizational skills with a teamwork spirit and leadership characteristics
- Experience as a people manager highly preferred.
Duties and Responsibilities
- Work closely with a multi-function team to deliver iPSC products, genome-edited iPSC lines, and differentiated cells.
- Participate and contribute to product development by strictly following iPSC culture and engineering protocols.
- Apply scientific knowledge, critical thinking, and problem-solving abilities to troubleshoot and refine processes and analytical methods/assays.
- Strictly follow established SOPs and instructions under GMP and ISO quality management systems.
- Adhere to good document practices: maintain and document GMP lab records and all required activities, effectively update results and project status in companywide informatics system.
- Contribute to GMP material inventory tracking.
- Uphold a personal and area hygiene and safe work environment.
Job Type: Full-time