Manufacturing Shift Supervisor - Orca Bio
Sacramento, CA 95811
About the Job
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 Manufacturing Supervisor plays a critical role overseeing the production of Orca's cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to manufacturing operators to ensure timely and compliant manufacturing.
Responsibilities
- Supervise and lead a team of manufacturing operators during designated shifts.
- Coordinate daily production activities to meet production schedules and quality standards for cell therapy products.
- Implement and enforce standard operating procedures (SOPs), protocols, and safety guidelines to ensure compliance with regulatory requirements (e.g., FDA, GMP).
- Train and mentor manufacturing staff on proper manufacturing procedures, equipment operation, and safety protocols.
- Monitor production processes, troubleshoot issues, and resolve deviations to ensure product quality and yield targets are met.
- Collaborate with Quality Assurance (QA) and Quality Control (QC) teams to conduct in-process checks, inspections, and batch record reviews.
- Maintain accurate documentation and records of production activities, batch records, and equipment logs in accordance with regulatory standards.
- Identify opportunities for process improvements and efficiency enhancements in manufacturing operations.
- Participate in investigations of deviations, incidents, and CAPAs (Corrective and Preventive Actions) related to manufacturing processes.
Education & Experience Requirements
- Minimum of high school diploma or GED
- A.S. degree is preferred, but not required
- Prior experience in GMP manufacturing, lab scale manufacturing
- Cell and gene therapy knowledge is beneficial
- 2+ years of previous supervisory or leadership experience is required
- related experience in the pharmaceutical/biotech industry, with increasing responsibilities
Personal Qualities & Physical Demands
- Ability to gown and work in clean rooms and Biosafety safety cabinets
- This is a shift position, working on site in Sacramento, CA, Monday through Friday to be decided at a later date
- Highly detail oriented with special attention to quality
- Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
- Strong interpersonal skills and ability to communicate effectively
- Ability to work in a collaborative manner
- Ability to work independently and as part of a team
- Highly tolerant and respectful of all team members
- A sense of humor is always appreciated
- Strong problem-solving skills
- Must be able to remain in a stationary position 50% of the time while in a biosafety cabinet/cleanroom environment which includes wearing a PPE gown
- 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
The anticipated 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, including shift differential pay, if applicable. You may also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations.
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.
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Source : Orca Bio