Lead, CMC Process Validation

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs.

host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.

With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

Summary :

The CMC Process Validation Lead (Director level) will play a pivotal role in developing and managing process validation principles and practices of early and late-stage cell therapy programs at Orca Bio.

Work will focus on activities to ensure all appropriate process design, control strategies, key quality elements, qualifications and validations are completed for Orca Bio's cell therapy drug products.

The validation team completes activities at both the Menlo Park development labs and commercial site in Sacramento. The position will work closely with other CMC functions and cross-functionally with Quality and Manufacturing Operations and will require some travel to the Sacramento site.

The ideal candidate has done cell therapy science in the process development space, and has experience creating validation plans and strategies in a GMP setting.

This person will manage our team of 6 scientists and should understand how to establish process controls, risk evaluations and manage validation campaigns with our commercial site.

Responsibilities

• Manage and develop strategic direction for all appropriate activities leading to process performance qualification (PPQ), associated CMC requirements and regulatory submissions
• Manage and influence strategy for the development and monitoring of critical process controls and continued process verifications
• Manages, tracks and reports on readiness / execution status for all proves validation activities and deliverables
• Generates PPQ documents (plans, protocols, reports) according to timelines and commitments
• Manage and mentor career development of cell therapy scientists; organize resourcing of projects and project assignments of group members
• Author and review protocols, technical reports, method SOPs and / or work instructions. Responsible for all appropriate documentation for regulatory submissions
• Develop and optimize validations for container closure, shipping systems and all appropriate validations needed for an IND and / or BLA submission for a cell therapy technology
• Collaborate with and provide training and guidance to process validation and CMC group members in defining, executing and analyzing studies
• Prepare and present high-quality data summaries and project progress updates to stakeholders and at cross-functional team meetings

Desired Qualifications

PhD in Pharmaceutical Sciences, Biology, Immunology, Cell Biology, with 12 years of relevant industry experience. Candidates with B.

S. / M.S. may also be considered with demonstrated leadership track record in process development and validation

• History with commercialization projects and successful track record of BLA projects
• Knowledge and broad understanding of validation principles associated with a GMP drug product manufacturing site. Good understanding of relevant ICH guidelines
• Experience working with contract service providers and consultant contributors externally to complete project assignments
• Experience in GMP cell therapy and / or biological product manufacturing, preferably with emphasis on cell therapy and individualized patient therapies
• Experience working with and leading cross functional teams such as CMC, Quality and Regulatory
• Outstanding written and verbal communication, self-starter with great interpersonal skills and strong planning / tracking skills
• Must be able to work in a fast paced, changing environment with demonstrated ability to manage multiple competing responsibilities with a high degree of self-motivation

The anticipated annual salary range for this job is based on prior experience in the role / industry, education, location, internal equity, and other job-related factors as permitted by law.

For remote-based candidates, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.

Other perks include free daily lunches and snacks at our on-site locations.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission.

We aren't afraid to ask why not and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

To learn more : https : / / orcabio.com / join-our-team /

all official communication will be from @orcabio.com; please beware of scams

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening.

Our employment activities, inquiries and offers are managed through our HR / Talent team, and all candidates are presented through this channel only.

We do not accept unsolicited resumes, and we rarely outsource recruitment.

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