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Director, MSAT

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.

We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.

The Director, MSAT is responsible for leading the Manufacturing Science and Technology team within the Orca organization. This role oversees manufacturing processes as they transfer from development into commercial operations and throughout the commercial lifecycle of the product. The Director, MSAT works closely with teams, such as Development, Quality, Operations, Regulatory Affairs and CMC to launch, scale-up and optimize operational attributes to ensure product quality, efficiency and compliance with regulatory standards. This position requires on-site attendance at our Sacramento facility.

Responsibilities

Lead a team of scientists, engineers and technical experts to support the launch, scale up and maintenance of late stage and commercial manufacturing processes.

Establish and maintain performance metrics to measure manufacturing operations.

Develop strategies to enhance manufacturing processes, including optimizing processes for investigation, corrective actions and change management for MSAT Projects.

Implement process improvements based on data analysis and scientific principles including focus on technology, alternate materials, shipping and labeling, and data from continuous process verification.

Drive the execution of various studies, qualifications and design of experiments related to deviations, process performance, and regulatory needs for commercial products.

Develop and drive practices for the transfer of processes from development into commercial manufacturing facilities.

Coordinate with the operations team to ensure successful implementation of new processes in commercial GMP environments.

Collaborate with cross functional teams to trouble shoot and resolve technical issues.

Lead and drive the preparation and review of data to support regulatory submissions.

Build and mentor the MSAT team ensure the team is equipped with the skills and tools to meet current and future manufacturing needs.

Education & Experience Requirements

B.S. in Engineering, Chemistry, Pharmacy or related scientific discipline required.

PhD in Chemical Engineering, Biochemistry or Analytical Chemistry is preferred.

Associate Director : Minimum of 8 years of relevant experience.

Director : Minimum of 10 years of experience, with demonstrated success in higher-level decision-making roles.

Experience with manufacturing processes and equipment in related fields : biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries.

4+ years of people leadership experience.

Prior experience in regulated, GMP manufacturing operations.

Strong communication and problem-solving skills.

Experience in Cell therapy manufacturing preferred.

Knowledge of automation, continuous process verification, investigation processes, process optimization.

Personal Qualities & Physical Demands

Highly detail oriented with special attention to quality, compliance and safety.

Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize.

Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment.

Strong interpersonal skills and ability to communicate effectively.

Ability to work in a collegial and collaborative manner, independently and part of a team.

Ability to work in a fast-paced start-up environment while following SOPs.

Highly tolerant and respectful of all team members.

Strong problem-solving skills with desire to improve upon established processes.

Ability to work in cleanroom environments and, at times, across various shifts.

Ability to follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition.

Occasional need to ascend / descend stairs within workspace; job requires standing / walking.

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 positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to competitive 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.

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.