Manufacturing Process Lead (3rd Shift)

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 are establishing manufacturing operations on the East Coast 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 Manufacturing Process Lead conducts cGMP manufacturing activities to produce clinical and commercial cell therapies and helps to optimize Manufacturing processes. The Lead ensures and adheres to quality standards, regulatory requirements and aseptic production techniques. This position involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. This position also entails on-shift oversight of production activities to ensure timely, efficient, and quality-driven execution of each day’s objectives.

Essential Duties & Key Responsibilities:

• Oversee execution of routine manufacturing and occasional scientific protocols
• Develop and refine procedures for cell separation technologies, sterile connections, and aseptic techniques
• Serve as subject matter expert for cell therapy processes and new technology
• Provide verification for results and ensure detailed records are maintained
• Prepare, maintain, trouble-shoot, and operate instruments
• Plan the shift - including break management, shift pass downs, and process appropriate decisions
• Supervise in-room operations and delegate individual tasks based on operator capacity
• Complete deviations
• Escalate issues appropriately
• Review and support continuous improvements of business processes, records, and SOPs
• Training and coaching employees
• Other duties as assigned

Minimum Qualifications:

• Bachelor’s degree in a science related field (Biology, engineering, etc.) or related field, required.  Master’s degree preferred
• 2-3 years of experience in GMP Manufacturing, process sciences, or discovery 
• Experience with aseptic techniques 
• Familiarity with cell/or gene therapy, including working with human cells, cell characterization methods, or cell separation techniques
• Direct or indirect people leadership preferred
• Flexibility to work outside standard business hours when needed to support site priorities, deadlines, or critical business needs.
3rd Shift: • Monday - Friday, 12:00am - 8:30am

Physical Demands

• Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

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. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.    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.