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.

The MSAT Process Engineer works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions.

Responsibilities

Performs ongoing monitoring of existing commercial products and processes
Generate metrics and reports for process monitoring and continuous process verification
Support process improvements and changes including electronic batch record creation and modifications
Investigates process events and implements corrective and preventive actions
Provides troubleshooting support for manufacturing events, equipment performance and material issues
Performs root cause analysis to isolate cause of events and determine appropriate corrective actions
Authors, executes and owns change controls, technical protocols, reports and activities to support improvements
Writes and ensure proper execution of validation protocols and testing in line with required life cycle management activities

Education & Experience Requirements

B.S. in Engineering or similar fields
3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries
Prior experience in regulated, GMP manufacturing operations
Experience in biotechnology and cell therapy manufacturing preferred
Strong communication and problem solving skills, with a desire to improve upon established processes

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
Strong interpersonal skills and ability to communicate effectively
Ability to work in a collegial and collaborative manner, independently and as 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
A sense of humor is always appreciated
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

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/

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