Engineer, Process Development

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 Process Development Engineer, CMC will focus on commercialization and post-commercial process optimization of allogeneic cell therapy manufacturing processes. You will contribute to technology transfer into GMP manufacturing, evaluation of replacement and novel raw materials, BLA content generation, scale-up/scale-out, and process/operational optimization to advance Orca’s clinical pipeline into commercialization. This role is expected to closely collaborate with multiple teams across Process Development, MSAT, Analytical Development, Regulatory Affairs, Quality and Manufacturing.

Responsibilities:

-Lead projects to optimize and implement process improvements related to closed and single-use cell therapy manufacture for pre-commercial and post-commercial manufacturing processes

·Coordinate implementation of process improvements and new process technology into clinical and

commercial GMP facilities

·Play a lead role for core activities during technology transfer of processes into GMP clinical and

commercial manufacturing, including on-floor support as Person-In-Plant and authoring and reviewing of technical documents

·Contribute to process characterization and process validation work packages to progress the CMC development of Orca’s clinical pipeline

·Author and review plans, protocols, technical reports and CMC sections of regulatory submissions

·Generate risk assessments and use quality risk management techniques to guide development efforts

·Collaborate with external vendors and internal engineering teams to design and implement novel automation and closed processing technologies for cell therapy production

·Participate in investigations and troubleshooting of both manufacturing issues and lab studies

Qualifications:

·PhD, MSc in Chemical Engineering, Biotechnology, or related field; candidates with Master’s or Bachelor’s degree will be considered with additional experience

·2-6 years of experience (depending on education) in process sciences or manufacturing

·Experience with commercial biologic (e.g., antibody, recombinant protein) processes; cell/gene therapy experience preferred

·Experience with aseptic techniques and closed manufacturing systems

·Experience with late-stage process development, including process characterization and/or process validation preferred

·Experience with regulatory (e.g., IND, BLA) authoring

·Experience with quality risk management (i.e., risk assessments)

·Ability to travel to Sacramento occasionally (10 – 20%)

Additional Attributes:

·Demonstrated organizational, record-keeping, and problem-solving skills, with an attention to detail

·Strong interpersonal skills including verbal and written communication

·Demonstrated success working independently as well as in a team environment

·Ability to act with urgency and agility to bring lifesaving therapies to patients

·Intense curiosity and a propensity to break with the status quo

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.