About Us:
Indapta is a clinical stage biotechnology company harnessing the natural power of the immune system to fight hematologic and solid cancers with its universal natural killer (NK) cell platform. The company’s allogeneic platform is based on a subset of NK cells, so called g-NK cells that are derived from healthy donors and are deficient in the FceR1g protein. These cells are particularly potent at killing cancer cells when combined with monoclonal antibodies currently clinically employed to specifically target and kill cancer cells. Indapta is working to bring this unique and powerful off-the-shelf cellular therapy to patients with cancer to overcome the limitations of currently available immunotherapies.
The Position:
Indapta seeks an experienced, biotech CMC quality professional at a director or senior director level. We offer the autonomy, excitement, and ability to contribute in an ambitious clinical-stage company moving from early to later phase clinical trials.
Responsibilities will include:
Lead the CMC QA function and partner with clinical, regulatory and CMC teams, including contracted CDMOs to ensure the successful planning, execution and delivery of projects and production activities. Develop and lead efforts for QA oversight of the manufacture of pre-clinical and clinical investigational product, including:
- Disposition of clinical batches
- Process Development activities
- Technical Reports
Partner with contract manufacturing and testing organizations to ensure the GMP compliance of operations performed.
Manage QA resources to perform quality activities, including review and of batch documentation - including manufacturing records, analytical data, and deviations/CAPA in preparation for lot disposition.
Review and approve relevant documentation including deviation investigations, change control, specifications, process, stability, and method validations.
Ensure quality of products produced/maintained at contract organizations through review and approval of key activities, including fulfillment of quality agreements, internal and audits.
Develop and maintain key quality metrics that support excellence in quality systems and processes, informing senior leadership of the intended outcomes and results.
Write and review relevant sections of regulatory submissions including IND's; Assist in responses to regulatory questions.
Ensure activities and deliverables comply with FDA, EMA, local regulations and guidance, SOPs and industry best practices.
Participate in continuous improvement initiatives to accomplish compliance, productivity, cost-effectiveness, and enhanced efficiencies of processes and procedures as they pertain to quality.
Participate due diligence activities for supplier qualification and technology transfer.
Participate in hosting inspections (regulatory or due diligence)
Other duties as needed.
Who you are:
Bachelor’s degree in chemistry, biology, biotechnology or related field
A minimum of 12 years of relevant industry experience (manufacturing, quality assurance, and/or quality control in biotechnology, biologics, and/or drugs) with at least 8 years in a quality role.
Previous experience working collaboratively with contract research organizations and ability to travel to manufacturing sites (TX) is required.
Ability to build positive relationships with key internal and external key stakeholders.
Demonstrated expertise in using logic and influencing skills to resolve disagreements.
Acts an internal consultant, proactively providing advice and counsel on quality assurance related topics.
Demonstrates effectively managing and implementing GMP-compliant quality system
Experience with a QMS and other software tools
Experience in the EMEA or other regulatory systems is a plus
Excellent writing skills on technical topics
What we can offer you:
We have a comprehensive total compensation package including medical, dental and vision benefits for you and your family. We want all of our employees to have the opportunity to become shareholders and all new hires receive stock options. The company also offers participation in the annual bonus program. The salary range for a Director level candidate, located in the Bay Area is $185,000 - $220,000 depending on skills and experience. We are open to employees working in Houston TX or remotely from the West Coast. The pay range for candidates residing outside of California will be dependent on the geography in which they are located.