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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.

Orca Bio is seeking a skilled Microbiology Quality Control Scientist to ensure the highest standards of quality and safety in our biotechnological processes. As a key member of our team, you will be responsible for conducting comprehensive microbiological analyses, identifying potential contamination risks, and implementing robust control measures. Your role will involve meticulous assessment of contamination risks throughout the manufacturing process to uphold regulatory compliance and product integrity.

Responsibilities:

· Perform microbiological testing on raw materials, in-process samples, and finished products to detect and quantify microbial contamination.

· Develop and validate microbiological testing methods, ensuring accuracy, precision, and reproducibility.

· Conduct contamination control risk assessments to identify potential sources of microbial contamination in the manufacturing environment.

· Implement and maintain effective contamination control strategies, including environmental monitoring programs and cleaning validation protocols.

· Collaborate with cross-functional teams to investigate and resolve microbiological deviations, implementing corrective and preventive actions as necessary.

· Support regulatory compliance by ensuring adherence to relevant quality standards, including cGMP, ISO, and FDA guidelines.

· Provide technical expertise and guidance to manufacturing personnel on microbiological best practices and contamination control measures.

· Stay abreast of emerging trends and advancements in microbiological testing methodologies, incorporating relevant innovations into quality control processes.

Qualifications:

· Bachelor's or Master's degree in Microbiology required.

· Minimum of 5+ years of experience in microbiological quality control within the biotechnology or pharmaceutical industry is preferred.

· Proficiency in microbiological testing techniques, including sterility testing, endotoxin analysis, and microbial enumeration.

· Strong understanding of contamination control principles and risk assessment methodologies.

· Experience with regulatory requirements for biopharmaceutical manufacturing, including cGMP and FDA guidelines.

· Excellent analytical skills with meticulous attention to detail.

· Effective communication skills with the ability to collaborate across interdisciplinary teams.

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/

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.