Manager, Manufacturing Sciences & Technology (MSAT)

Join Orca Bio, a pioneering late-stage biotechnology company, as we redefine the transplant process for blood cancer patients. Our innovative cell therapies aim to improve survival rates while minimizing risks, offering hope to over one million individuals currently battling blood cancer in the United States.Our clinical manufacturing facility in Sacramento, CA, is crucial for the production of high-precision cell therapy products. This site plays an integral role in advancing our clinical pipeline and ensuring a reliable supply of therapies for our clinical trials.We are seeking an Associate, Cell Therapy Production for our 2nd shift, working Monday through Friday from 3 PM to 11:30 PM. Reporting to the assigned supervisor in clinical manufacturing, this role is vital in the production of our cell therapy products, ensuring compliance with rigorous quality standards, regulatory requirements, and aseptic production techniques. Responsibilities include executing manufacturing processes, maintaining and cleaning production equipment, and accurately documenting production activities in a highly regulated environment. You will collaborate closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) as part of a cross-functional team to carry out GMP manufacturing runs.

Join a pioneering biotechnology company dedicated to transforming the lives of individuals battling blood cancer. Orca Bio is at the forefront of innovative cell therapy solutions, aiming to improve survival rates while minimizing risks associated with traditional transplant methods. Our mission is clear: to replace patients' blood and immune systems with healthier alternatives and restore their quality of life.As a Cell Therapy Production Associate for Oncology (Night Shift), you will play an essential role in the production of our groundbreaking cell therapy products. Your responsibilities will include ensuring compliance with rigorous quality standards, regulatory guidelines, and aseptic manufacturing techniques. Reporting directly to the assigned supervisor in commercial manufacturing, you will execute manufacturing processes, maintain and clean production equipment and workstations, and accurately document all production activities in a highly regulated setting. You will collaborate closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) teams to ensure successful GMP manufacturing runs as part of a dynamic, cross-functional team.Night Shift Hours:• 6:00 PM to 6:30 AM or• 6:30 PM to 7:00 AMWork Week Schedule:• Sunday, Monday, Tuesday + every other Wednesday or• Thursday, Friday, Saturday + every other Wednesday

Join the fight against blood cancer at Orca Bio, a pioneering late-stage biotechnology company dedicated to transforming the transplant process through groundbreaking cell therapies. Our mission is to enhance survival rates while minimizing risks associated with traditional allogeneic stem cell transplants. Our investigational cell therapy products aim to not only restore healthy blood and immune systems but also to rejuvenate lives.Our state-of-the-art clinical manufacturing facility in Sacramento, CA, is the backbone of our operations, dedicated to producing high-precision cell therapy products that are crucial for our clinical trials. As part of our team, you will contribute significantly to the advancement of our clinical pipeline and ensure a consistent supply of therapies for patients in need.We are currently seeking an Associate, Cell Therapy Production for our 3rd shift, working on-site from Monday to Thursday, 9 PM to 7:30 AM. In this pivotal role, you will report to the assigned supervisor of clinical manufacturing and play a vital part in the production of our cell therapy products. Your responsibilities will include adhering to strict quality standards, regulatory requirements, and aseptic production techniques. You will execute manufacturing processes, maintain production equipment, and meticulously document production activities in a highly regulated environment. Collaboration with Materials Management, Quality Control (QC), and Quality Assurance (QA) is essential as you participate in GMP manufacturing runs within a cross-functional team.

At Orca Bio, we are dedicated to transforming the lives of individuals battling blood cancer. As a late-stage biotechnology company, we are pioneering next-generation cell therapies that aim to improve survival rates and minimize risks associated with traditional allogeneic stem cell transplants. Our vision is to provide patients with purified, high-precision investigational cell therapies that not only restore their blood and immune systems but also enhance their quality of life.We are currently seeking a dedicated Associate, Cell Therapy Handling and Cryopreservation - Night Shift to join our Manufacturing team. In this pivotal role, you will be responsible for the receipt of patient materials (leukapheresis/blood), the cryopreservation of cellular products, and the preparation and coordination of final drug product shipments. Ideal candidates will possess a strong understanding of GMP manufacturing and cell therapy processes, and be adept at executing multiple tasks in a fast-paced environment.Night Shift Hours:• 6:00 PM to 6:30 AM or• 6:30 PM to 7:00 AMWork Week Schedule:• Sunday, Monday, Tuesday + every other Wednesday or• Thursday, Friday, Saturday + every other Wednesday

Join Orca Bio, a pioneering late-stage biotechnology company committed to transforming the transplant process and improving survival rates for patients battling blood cancers. Our innovative cell therapies focus on enhancing patient outcomes with significantly reduced risks compared to traditional allogeneic stem cell transplants. By utilizing our high-precision investigational cell therapies, we aim to restore not just the blood and immune systems of patients but also their lives.Our advanced 100,000-square-foot manufacturing facility located in Sacramento, CA, plays a crucial role in ensuring the consistent delivery of our cell therapy products, supporting our clinical pipeline and future commercial availability of life-saving therapies.Position Overview: We are seeking dedicated part-time contractors to provide specialized courier services that are critical to our mission of delivering life-saving cellular therapies for bone marrow donation and transplantation. In this role, you will be responsible for the secure, timely, and compliant transport of blood components and related materials from our laboratory facilities to hospitals and treatment centers across the nation.As a Cell Therapy Medical Courier (also known as Transport Associate), you will serve as a professional service provider, ensuring the transport of highly sensitive medical specimens while strictly adhering to handling, documentation, and chain-of-custody protocols. Ideal candidates will demonstrate reliability, keen attention to detail, and excellent communication skills, along with the professionalism and discretion necessary to represent Orca Bio in a highly regulated and time-sensitive clinical environment.

Orca Bio is a pioneering biotechnology company dedicated to transforming the lives of individuals battling blood cancer. With over a million Americans currently affected, we are revolutionizing the allogeneic stem cell transplant process through our innovative cell therapies, which aim to significantly improve survival rates while minimizing risks associated with traditional methods. Our high-precision investigational cell therapies are designed to replace patients' blood and immune systems with healthier alternatives, ultimately restoring their quality of life.The Quality Control Technician - Night Shift plays a vital role in our cell therapy manufacturing facility by conducting both routine and non-routine testing to uphold the highest quality standards. Your contributions will be essential in ensuring the integrity and safety of our cell therapy products, directly impacting patient outcomes.

About Orca Bio Orca Bio is a late-stage biotechnology company focused on transforming stem cell transplants for blood cancer patients. The team develops next-generation cell therapies designed to improve survival rates and reduce risks like graft versus host disease. With a 100,000-square-foot manufacturing facility in Sacramento, CA, Orca Bio supports both clinical trials and future commercial distribution of its therapies. Role Overview: Quality Assurance Specialist (Weekend Shift) This Quality Assurance Specialist role covers the weekend shift: Friday through Monday. The position plays a key part in maintaining Orca Bio’s quality policy and ensuring that cell therapy products meet rigorous standards before release. What You Will Do Manage and maintain quality systems, including production records and deviation management Oversee processes for deviations, change control, and corrective and preventive actions (CAPA) Handle document management to ensure accurate and compliant record-keeping Make timely batch disposition decisions to support rapid product processing and release Help uphold compliance with internal quality standards and regulatory requirements Location and Shift Details Location: Sacramento, CA Schedule: Friday through Monday (weekend shift) Impact This role directly supports the delivery of innovative cell therapies, contributing to better outcomes for patients facing blood cancers. Learn More For more on allogeneic stem cell transplants, see the Mayo Clinic overview.

Orca Bio develops precision cell therapies for blood cancer, with a focus on improving allogeneic stem cell transplants. The Sacramento, CA site plays a critical role in manufacturing these therapies and supporting clinical trials. Role overview The Quality Assurance Specialist (Day Shift) helps maintain high standards for product safety and compliance. This position manages key quality systems and ensures that each batch meets required specifications before release. What you will do Oversee quality systems, including deviation management, change controls, CAPA (corrective and preventive actions), and document management Review and manage production records Make timely batch disposition decisions to uphold quality standards before product release Support efficient processing timelines for cell therapy products Impact This role directly supports the delivery of safe, high-quality cell therapy products to patients in clinical trials, helping Orca Bio advance its mission and meet critical timelines.

Join Orca Bio, a pioneering biotechnology firm dedicated to transforming the transplant process for blood cancer patients. With over one million individuals in the U.S. battling blood cancer, our advanced cell therapies aim to significantly enhance survival rates while reducing associated risks. Our state-of-the-art 100,000-square-foot manufacturing facility located in Sacramento, CA, is vital for the consistent production and delivery of our high-precision cell therapy products.The Associate Director of Supply Chain Planning & Procurement will spearhead our planning and procurement initiatives, optimizing manufacturing execution systems (MES) and enterprise resource planning across our cell therapy manufacturing sites. This key role is responsible for ensuring compliant and scalable planning processes, utilizing digital systems for real-time visibility and seamless production of clinical and commercial cell therapy products. Collaborating with Manufacturing, Finance IT, Facilities, and Quality teams, you will establish a robust planning foundation that supports data-driven decision-making.

Over one million individuals in the United States are currently battling blood cancer. While the traditional allogeneic stem cell transplant has provided hope for many, it can also carry significant risks, including fatal outcomes and severe complications such as graft versus host disease. At Orca Bio, a cutting-edge biotechnology firm, we are revolutionizing the transplant process by creating next-generation cell therapies aimed at significantly enhancing survival rates while minimizing risks. Our goal is to not only replace patients' blood and immune systems with healthy alternatives but also to restore their quality of life. We have established a state-of-the-art 100,000-square-foot manufacturing facility in Sacramento, CA, to guarantee the consistent and reliable delivery of our high-precision cell therapy products. This facility is crucial for advancing our clinical pipeline and ensuring the future commercial availability of our life-saving therapies. The Director, Commercial Manufacturing will lead our cell therapy manufacturing operations and production support functions to ensure the reliable, compliant, and timely delivery of patient-specific therapies. This role is essential in driving consistent batch execution, operational discipline, and cross-functional collaboration to meet on-time patient delivery, all while upholding the highest quality and safety standards.The Director will develop and maintain robust production systems, implement lean manufacturing principles, and spearhead continuous improvement initiatives to scale operations in a dynamic, GMP-regulated environment.

Join the fight against blood cancer at Orca Bio, a pioneering biotechnology company dedicated to transforming the transplant process. With over one million individuals battling blood cancer in the United States, our mission is to enhance survival rates and minimize risks through next-generation cell therapies. Our state-of-the-art, 100,000-square-foot manufacturing facility located in Sacramento, CA, plays a vital role in ensuring the reliable production of our innovative cell therapy products, ultimately restoring the lives of patients.As the Manager of Commercial Manufacturing, you will oversee the daily operations of our GMP manufacturing facility. Your responsibilities will include managing the production of cell-based therapies while ensuring compliance with regulatory guidelines, standard operating procedures (SOPs), and quality standards. You will have the opportunity to lead a dedicated team of Supervisors and support Cell Therapy Production Associates, delivering patient batches with exceptional safety, quality, and reliability.

At Orca Bio, we are on the forefront of redefining the allogeneic stem cell transplant process, aiming to enhance survival rates while minimizing associated risks. Our innovative approach focuses on next-generation cell therapies that not only aim to replace but also restore patients' blood and immune systems, ultimately improving their quality of life. We have established a cutting-edge 100,000-square-foot manufacturing facility in Sacramento, CA, dedicated to the reliable production of our high-precision cell therapy products, critical for advancing our clinical pipeline and ensuring the future availability of life-saving therapies. The Supervisor of Quality Control (QC) is vital to our mission, responsible for managing daily QC laboratory operations to ensure compliance with regulatory standards, internal protocols, and high-quality expectations. This role is essential in maintaining data integrity through meticulous audit trail reviews, leading investigations into out-of-specification (OOS) results, and ensuring the laboratory is always prepared for inspections.

Over one million individuals in the United States are currently battling blood cancer. Although allogeneic stem cell transplants have historically provided hope, they can also lead to severe complications, including fatal outcomes and conditions like graft versus host disease. At Orca Bio, a pioneering late-stage biotechnology firm, we are revolutionizing the transplant landscape by developing advanced cell therapies aimed at significantly enhancing survival rates while minimizing risks. Our innovative, high-precision investigational cell therapies are designed not only to replace patients' blood and immune systems with healthy ones but also to restore their quality of life.Our cutting-edge 100,000-square-foot manufacturing facility located in Sacramento, CA, is crucial for ensuring the consistent and reliable delivery of our high-precision cell therapy products. This facility plays a vital role in advancing our clinical pipeline and supporting the future commercialization of our life-saving therapies.Didn’t find a specific role that seems like the ideal match? We still welcome your application. Orca Bio is rapidly expanding, and we are constantly on the lookout for passionate and driven individuals eager to help us shape the future of cell therapy at our Bay Area and Sacramento locations, as well as in certain remote or field-based roles.This general application serves as an opportunity for you to introduce yourself to our Recruitment Team. Please submit your resume along with a brief note detailing your interests and how you envision contributing to Orca Bio. We will keep your information on file and reach out when a suitable opportunity arises, now or in the future.Thank you for your interest in becoming part of our team!What We OfferEligible candidates may receive pre-IPO equity, along with:- Competitive medical, dental, and vision benefits- Flexible paid time off and holidays- 401(k) retirement plan- Life and accidental death & disability insurance- Parental leave benefits- Complimentary daily lunches and snacks at our facilities

Join Orca Bio, a pioneering late-stage biotechnology firm dedicated to transforming the transplant landscape. We are committed to advancing cell therapies that significantly improve survival rates while minimizing risks associated with traditional allogeneic stem cell transplants. Our state-of-the-art manufacturing facility, spanning 100,000 square feet in Sacramento, CA, plays a crucial role in ensuring the reliable delivery of our high-precision investigational cell therapies. The Engineer, Manufacturing Sciences & Technology (MSAT) will focus on enhancing the efficiency and safety of our drug product manufacturing processes. This position entails lifecycle management of commercial products, process monitoring, troubleshooting, implementing and validating process improvements, and supporting investigations as well as corrective and preventive actions.

About Orca Bio Orca Bio is a late-stage biotechnology company focused on transforming the transplant process for patients with blood cancer. Our clinical manufacturing facility in Sacramento, CA, produces next-generation cell therapies designed to improve survival rates and reduce risks for patients in our trials. Role Overview The Quality Control Environmental Monitoring Technician helps ensure the safety and quality of our cell therapy products. This technician monitors environmental conditions in the manufacturing facility, supporting compliance with strict quality standards and regulatory requirements. Main Responsibilities Conduct routine and non-routine environmental monitoring and testing within the manufacturing facility. Follow established operating procedures for all testing and monitoring activities. Perform air and surface monitoring to maintain compliance with regulatory guidelines. Collect samples from critical areas throughout the facility. Maintain and calibrate environmental monitoring equipment to ensure accurate readings. Keep thorough records of all monitoring activities, including sampling plans, results, and any corrective actions taken. Carry out environmental analyses such as microbial and particulate matter testing. Perform basic laboratory functions, including reagent preparation. Location This position is based onsite at our clinical manufacturing facility in Sacramento, CA.

Join Our Team at 21st Century Home Health Services (21HHS)At 21HHS, we prioritize empathy, compassion, and understanding in caring for our patients—treating them like family. With a dedicated workforce of over 600 employees, we proudly stand as the largest home health agency in San Francisco and the fastest-growing in the Bay Area. We currently serve over 4,000 patients across multiple counties, including San Francisco, San Mateo, Santa Clara, and Sacramento, and are excited to expand into Marin and Sonoma counties.Our clinical team is not only devoted to the patients but also to supporting one another. Our commitment to excellence is reflected in our hospital readmission rates, which consistently remain below 10%, well below the industry average of over 15%.Recognized as a 2024 Top Workplace, 21HHS fosters a culture of support and professional growth through open communication and development opportunities.Key Achievements:- Ranked 3rd among medium-sized companies and 1st among home health agencies in the San Francisco Chronicle Top Workplaces in the Bay Area.- Nationally recognized as 12th among medium-sized healthcare companies and 1st among home health agencies.Our patient and employee feedback on platforms like Yelp, Google, Glassdoor, and Indeed reflects our commitment to outstanding care and a positive workplace. By focusing on engagement and satisfaction, 21HHS attracts top clinical talent and delivers exceptional outcomes, solidifying our leadership in the home health sector.Position Overview:The Clinical Supervisor - Therapy plays a crucial role in coordinating and managing patient care. As the primary point of contact for field clinicians, this position ensures that support is readily available and timely. The Clinical Supervisor-Therapy oversees the delivery of care and services while supervising clinical personnel. This leadership role is essential for the effective oversight of clinicians providing care in patients’ homes.Work Schedule:2 days in the Sacramento office and 3 days in the field, conducting 12 supervisory patient visits weekly.Coverage Area: Sacramento, Placer, and Yolo Counties.

Join our dynamic team at RR Donnelley as a Bindery Operator 1 on the 2nd shift, where you will play a crucial role in the print production process. Your responsibilities will include setting up and operating binding machines, ensuring quality control, and adhering to safety protocols. This is an excellent opportunity for those looking to advance their careers in the printing industry.

Join Orca Bio, a pioneering biotechnology company dedicated to transforming the transplant process for blood cancer patients. Our mission is to develop next-generation cell therapies that significantly enhance survival rates while minimizing risks associated with traditional allogeneic stem cell transplants. By utilizing our high-precision investigational cell therapies, we aim to restore not just the blood and immune systems of our patients, but also their quality of life.The Material Handler - Night Shift plays a crucial role in the efficient management of pharmaceutical materials and products for our advanced cell therapy solutions. This position is responsible for ensuring compliance with stringent quality standards and regulatory requirements while executing processes related to warehouse inventory, kitting materials for production, and overseeing the intake, movement, and shipping of drug products and samples.Night Shift Hours:• 6:00 PM to 6:30 AM or• 6:30 PM to 7:00 AMSchedule:• Sunday, Monday, Tuesday + every other Wednesday or• Thursday, Friday, Saturday + every other Wednesday

Orca BioSystems seeks a Training Specialist to join the night shift team in Sacramento, CA. This role centers on developing and presenting training programs aimed at building staff skills and knowledge. Role overview The Training Specialist will design and deliver learning sessions that help employees perform at their best. By supporting staff development, this position plays a key part in upholding strong service standards and consistent operational quality across the organization. What you will do Create and implement training materials tailored to staff needs Lead training sessions during the night shift Support efforts to maintain high-quality operations and service Location and schedule This is an on-site role based in Sacramento, CA, working during night shift hours.