Microbiology Quality Control Scientist

Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.

Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio's platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.

Summary:

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.

The anticipated annual salary for this U.S. based job is $90,000- $120,000. The final offer will be based on professional experience previously in this role/industry, education, geographic 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. Actual compensation may vary. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, vision, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Total compensation will be determined at the Company's sole discretion.

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 patients who need them.

We strive to do things right, and to embody our core values of passion, courage, and integrity. Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate daily on a path that hasn't been paved. This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission. It means we aren't afraid to ask "why not," and encourage lively discourse around rethinking the status quo.

We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.

We're proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.

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 department, and all candidates are presented through this channel only. We do not accept unsolicited resumes.