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 Case Management Lead will lead the day-to-day operations of Orca Bio's case management function supporting Orca-T, our investigational high-precision cell therapy. This individual will oversee a team of Cell Therapy Case Managers and be responsible for ensuring efficient, accurate, and empathetic case coordination across treatment centers. You will play a key role in building Orca Bio's customer service model during launch readiness, developing SOPs, defining service expectations, and establishing the infrastructure for a scalable order management function. This role is ideal for someone who thrives in a launch-phase environment and is excited to shape how Orca Bio partners with treatment centers at every touchpoint of the therapy journey. Location: preferential treatment will be given to candidates located near one of Orca Bio's offices in California.Essential Duties & Key Responsibilities
Team Leadership & Daily Operations:
Oversee the daily operations of the case management team, including case assignment, workflow monitoring, coverage, and adherence to service level expectations.
Create and manage the staffing and scheduling model for the order management/case management function, ensuring optimal patient throughput and site experience.
Monitor case activity, respond to escalations, and provide real-time support to case managers and treatment centers.
Lead daily huddles, ensure timely internal communication, and reinforce best practices and SOP compliance.
Foster a high-performance, best-in-class, service-oriented, and a supportive, cohesive culture within the team.
Launch Readiness & Continuous Improvement:
Collaborate with Commercial and Technical Operations leadership to define the Orca-T customer service model, including workflows, team structure, escalation protocols, and cross-functional handoffs.
Define, draft and continuously refine case management SOPs, work instructions, and training materials.
Contribute to the design and implementation of Orca Bio's commercial ordering platform.
After launch, track and report on key performance indicators, identifying trends and opportunities for team optimization.
Partner with cross-functional stakeholders to resolve operational gaps and improve case handling efficiency.
Minimum Requirements
5-8+ years of experience in patient case management, order coordination, transplant operations, or healthcare call center leadership, preferably in cell or gene therapy, oncology, or complex therapeutics.
At least 2 years in a team lead or supervisory capacity, with responsibility for scheduling, coaching, mentoring, and daily operations.
Player-coach mentality.
Strong understanding of treatment center workflows, transplant coordination, apheresis, and chain-of-identity logistics.
Excellent interpersonal skills with a service-first mindset and calm, solution-oriented approach to escalation management.
Strong organizational and problem-solving skills with the ability to work under pressure in a launch-phase environment.
Experience with call center structure, shift design, or customer service models is a plus.
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.
$56k-102k yearly est. Auto-Apply 60d+ ago
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Cell Therapy Case Management Lead
Orca Bio 4.1
Orca Bio job in Sacramento, CA
Job DescriptionMore 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 Case Management Lead will lead the day-to-day operations of Orca Bio's case management function supporting Orca-T, our investigational high-precision cell therapy. This individual will oversee a team of Cell Therapy Case Managers and be responsible for ensuring efficient, accurate, and empathetic case coordination across treatment centers. You will play a key role in building Orca Bio's customer service model during launch readiness, developing SOPs, defining service expectations, and establishing the infrastructure for a scalable order management function. This role is ideal for someone who thrives in a launch-phase environment and is excited to shape how Orca Bio partners with treatment centers at every touchpoint of the therapy journey. Location: preferential treatment will be given to candidates located near one of Orca Bio's offices in California.Essential Duties & Key Responsibilities
Team Leadership & Daily Operations:
Oversee the daily operations of the case management team, including case assignment, workflow monitoring, coverage, and adherence to service level expectations.
Create and manage the staffing and scheduling model for the order management/case management function, ensuring optimal patient throughput and site experience.
Monitor case activity, respond to escalations, and provide real-time support to case managers and treatment centers.
Lead daily huddles, ensure timely internal communication, and reinforce best practices and SOP compliance.
Foster a high-performance, best-in-class, service-oriented, and a supportive, cohesive culture within the team.
Launch Readiness & Continuous Improvement:
Collaborate with Commercial and Technical Operations leadership to define the Orca-T customer service model, including workflows, team structure, escalation protocols, and cross-functional handoffs.
Define, draft and continuously refine case management SOPs, work instructions, and training materials.
Contribute to the design and implementation of Orca Bio's commercial ordering platform.
After launch, track and report on key performance indicators, identifying trends and opportunities for team optimization.
Partner with cross-functional stakeholders to resolve operational gaps and improve case handling efficiency.
Minimum Requirements
5-8+ years of experience in patient case management, order coordination, transplant operations, or healthcare call center leadership, preferably in cell or gene therapy, oncology, or complex therapeutics.
At least 2 years in a team lead or supervisory capacity, with responsibility for scheduling, coaching, mentoring, and daily operations.
Player-coach mentality.
Strong understanding of treatment center workflows, transplant coordination, apheresis, and chain-of-identity logistics.
Excellent interpersonal skills with a service-first mindset and calm, solution-oriented approach to escalation management.
Strong organizational and problem-solving skills with the ability to work under pressure in a launch-phase environment.
Experience with call center structure, shift design, or customer service models is a plus.
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.
$73k-112k yearly est. 7d ago
National (Senior) Director, Field Medical Affairs
Orca Bio 4.1
Remote Orca Bio 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.
Position Summary:The National (Senior) Director of Field Medical Affairs serves as the strategic and operational leader of Orca Bio's field-based Medical Science Liaison (MSL) organization. With the national MSL team hired, onboarded, and actively deployed, this role is accountable for optimizing performance, advancing scientific excellence, and scaling the field medical function in alignment with launch readiness and pipeline expansion. This leader will partner closely with Medical Affairs leadership and cross-functional stakeholders to ensure high-impact, compliant scientific engagement across priority institutions. Travel: up to 50-60% domestic and international travel required.Responsibilities:
Lead, mentor, and develop an established national MSL team, ensuring ongoing scientific excellence, performance management, and professional growth
Evolve and optimize MSL operational frameworks, SOPs, training programs, and CRM utilization to support launch and post-launch needs
Translate Medical Affairs strategy into clear field execution plans with defined objectives, metrics, and accountability
Advise Medical Affairs leadership on MSL coverage models, territory design, and future headcount expansion aligned with indication growth and organizational scale
Oversee strategic KOL identification, engagement planning, and scientific exchange to support launch readiness, data dissemination, and insight generation
Direct compliant collection, synthesis, and internal communication of actionable field insights to inform Medical, Clinical Development, Commercial, and Access strategies
Provide strategic oversight of field medical support for clinical trials, including investigator engagement and site education
Partner cross-functionally on congress strategy, advisory boards, medical education initiatives, and special enterprise priorities
Ensure the highest standards of compliance with FDA, OIG, PhRMA, and Orca Bio policies governing scientific exchange
Represent Orca Bio at scientific congresses, advisory boards, and external medical forums
Maintain deep scientific and clinical expertise in hematologic malignancies and cell therapy through continuous learning
Minimum Qualifications:
Doctorate-level advanced scientific or clinical degree (MD, PharmD, PhD, or MSN required)
8+ years of Medical Affairs experience, including prior MSL experience and ≥3 years leading field-based medical teams
Demonstrated success leading field medical organizations through launch or late-stage development
Strong command of US medical affairs compliance requirements and field governance
Proven ability to lead, coach, and scale high-performing MSL teams
Exceptional strategic thinking, communication, and cross-functional leadership skills
Preferred Qualifications:
Cell and/or gene therapy experience
Experience working in small biotech company or start-up environments
Direct experience supporting first-launch or near-launch assets
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.
$76k-155k yearly est. Auto-Apply 60d+ ago
Specialist, Logistics Program
Orca Bio 4.1
Orca Bio job in Sacramento, CA
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 have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) 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 Specialist, Logistics ensures the secure and timely transport of donor cells and drug products between Orca Bio's manufacturing sites and transplant centers. This role is responsible for scheduling couriers, coordinating logistics with internal stakeholders and external donor and recipient organizations, and maintaining compliance with regulatory requirements. The ideal candidate is proactive, solutions-oriented, and able to work independently in a fast-paced environment, with strong attention to detail, a sense of urgency, and the ability to troubleshoot issues in real time.Physical Demands
Production Associates: 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.
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.
Work Conditions
Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
Must be comfortable regularly participating in video-based meetings.
May be required to work scheduled overtime, weekends, or holidays based on business needs.
Key Responsibilities
Schedule couriers to facilitate donor cell pickups and deliveries to Orca Bio manufacturing sites in Sacramento.
Coordinate outbound shipments of patient drug products to recipient sites.
Manage flight and travel logistics for couriers, liaising with airlines and travel providers.
Actively monitor shipments and proactively resolve any delays or issues in real time.
Communicate changes urgently and professionally with all impacted stakeholders.
Partner with clinical schedulers and commercial case managers to troubleshoot and triage non-routine issues during transports.
Ensure all documentation and compliance requirements for pickups and deliveries are met.
Support communication flow between internal teams, couriers, and external partners to ensure secure and timely deliveries.
Liaise with third-party couriers and troubleshoot transportation issues as they arise.
Review and approve courier invoices; assist in performance tracking and optimization.
Contribute to training materials and ensure the courier team remains compliant and current.
Continuously evaluate and improve logistics workflows to support operational scalability.
Participate in on-call coverage during active courier transports to handle non-routine issues.
Assist with additional logistics and operations-related projects as needed.
Education & Experience
Bachelors degree and 2-3 years of relevant logistics experience required. B.S. in biology, life sciences, or logistics preferred.
Proven success in logistics coordination, preferably in a regulated environment.
Familiarity with handling biological materials and associated transportation regulations is a plus.
Proficiency in logistics tracking systems or software required.
Preferred Experience
Logistics or courier coordination in fast-paced, time-sensitive industries (e.g., healthcare, biotech, or medical transport).
Working with regulated materials, such as biological specimens or pharmaceuticals, with knowledge of chain-of-custody, IATA, or DOT compliance.
Real-time problem-solving and communication during transport disruptions or delays.
Managing relationships with vendors, third-party couriers, airlines, and internal stakeholders simultaneously.
Exposure to continuous improvement efforts, workflow scaling, or SOP development.
Familiarity with logistics tools and platforms such as shipment tracking systems, Google Workspace, Smartsheet, or equivalent.
Personal Qualities
Highly detail-oriented, with an unwavering commitment to quality, safety, and compliance.
Takes ownership and drives forward without waiting for instruction.
Is naturally curious, eager to learn, and energized by solving problems.
Brings creative solutions to unexpected challenges.
Is comfortable juggling multiple priorities in a fast-paced, startup environment.
Communicates clearly and professionally with internal and external stakeholders.
Works both independently and collaboratively with a team-first mindset.
Stays calm under pressure and adapts quickly to change.
Embraces a positive attitude, a collaborative spirit, and a good sense of humor.
Can work flexible or off-shift hours to support urgent logistics needs.
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. You will also be eligible to receive pre-IPO equity, in addition to competitive 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.
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.
$69k-117k yearly est. Auto-Apply 60d+ ago
Join Our Talent Community
Orca Bio 4.1
Orca Bio job in Menlo Park, CA
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 have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) 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.
Didn't find an open role that feels like the perfect fit?
We'd still like to hear from you. Orca Bio is growing fast, and we're always looking for passionate, driven people who want to help us transform the future of cell therapy at our Bay Area and Sacramento sites (and in some cases, remote/field based).
This general application is a way for you to introduce yourself to our Recruiting Team. Please submit your resume and a brief description letting us know your areas of interest and how you'd like to contribute at Orca Bio. We'll keep your information on file and reach out if something aligns now-or in the future.
Thanks for your interest in joining the pod!
What We Offer
You may be eligible to receive pre-IPO equity, in addition to:- Competitive medical, dental, and vision benefits- Flexible PTO and paid holidays- 401(k) plan- Life and accidental death & disability coverage- Parental leave benefits- Free daily lunches and snacks at our on-site locations Physical Demands
Production Associates: 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.
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.
Work Conditions
Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
Must be comfortable regularly participating in video-based meetings.
May be required to work scheduled overtime, weekends, or holidays based on business needs.
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.
$29k-48k yearly est. Auto-Apply 60d+ ago
Technician, Facilities/Maintenance
Orca Bio 4.1
Orca Bio job in Sacramento, CA
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 Technician, Facilities/Maintenance is responsible for supporting the maintenance and repair of facilities and associated infrastructure across multiple production sites producing clinical and commercial drug products. This role involves utilization of a Computerized Maintenance Management System (CMMS) to execute and document preventative and corrective maintenance activities to ensure compliant and reliable operations to support production requirements to meet customer needs.Job Duties and Key Responsibilities
Perform or coordinate preventive and corrective maintenance on the facility and associated infrastructure
Coordinate onsite preventative and corrective maintenance to be completed by service providers
Escort of service providers in restricted access areas during execution of facility and asset maintenance activities
Review and approval of service provider documentation, and completion of tasks in the CMMS
Maintain documentation in accordance with company standards
Ensure that facilities and associated infrastructure are maintained to applicable regulatory and GMP requirements
Participate in the continuous improvement of facility standards, specifications, procedures, and business processes
Other duties as assigned
Respond to emergency maintenance requests during off-hours as needed
Education & Experience Requirements
High school diploma or GED required, associate's degree or certification in facility maintenance preferred
2 years of experience in GMP manufacturing facility, preferably cell therapy, biotechnology or pharmaceutical
Experience in use of a CMMS system for managing execution of maintenance activities
Experience in execution of preventative and corrective maintenance of a GMP manufacturing facility and associated infrastructure
Experience coordinating onsite maintenance activities completed by service providers
Personal Qualities & Physical Demands
Ability to multitask and manage multiple responsibilities simultaneously; able to prioritize
Demonstrates strong work ethic and problem-solving skills
Willing to support sites after-hours on an as needed or on-call basis
Strong people skills and ability to communicate effectively
Ability to gown and work in cleanroom areas
Ability to work in a collaborative manner, independently and as part of a team
Ability to work in a fast-paced start-up environment while following documented procedures and instructions.
Ascend/descend stairs within the workspace; job requires sitting, standing, walking
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. You will 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.
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.
$39k-54k yearly est. Auto-Apply 60d+ ago
Engineer / Sr. Engineer, Operational Excellence
Orca Bio 4.1
Orca Bio job in Sacramento, CA
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 have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) 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.
Summary of Role: We are looking for a results-driven and detail-oriented Operational Excellence Engineer to join our team, focusing on manufacturing optimization and the development of metrics to drive operational improvements. This role will be pivotal in enhancing production efficiency, reducing costs, and ensuring high-quality standards through the use of data-driven decision-making and process optimization. The ideal candidate will have a strong background in manufacturing processes, operational excellence methodologies (Lean Six Sigma), and the ability to implement key performance metrics that drive continuous improvement. Physical Demands
Production Associates: 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.
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.
Work Conditions
Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
Must be comfortable regularly participating in video-based meetings.
May be required to work scheduled overtime, weekends, or holidays based on business needs.
Responsibilities
Manufacturing Process Optimization: Lead and implement continuous improvement initiatives aimed at optimizing manufacturing processes. Use Lean, Six Sigma, and other operational excellence tools to streamline production workflows, reduce waste, and increase overall efficiency.
Metrics Development & Monitoring: Define, implement, and monitor key performance indicators (KPIs) that track the efficiency, quality, and effectiveness of manufacturing operations. Develop dashboards and reporting tools to ensure real-time visibility into process performance.
Data Analysis & Reporting: Collect and analyze data related to production metrics, production performance, cycle times, etc. Identify trends and areas of improvement and use data to drive decision-making for process enhancements.
Cross-Functional Collaboration: Work closely with operations, engineering, quality, and supply chain teams to understand challenges, identify bottlenecks, and optimize processes across departments. Facilitate communication between teams to ensure alignment on improvement initiatives.
Project Management: Lead projects aimed at improving manufacturing processes and performance. Manage project timelines, budgets, and resources to ensure successful completion.
Compliance & Quality Assurance: Ensure all manufacturing optimization activities comply with industry standards and regulations (e.g., GMP, ISO). Work closely with the quality team to ensure that improvements maintain or enhance product quality and safety.
Continuous Improvement Culture: Foster a culture of continuous improvement within the organization, encouraging employees to contribute ideas, solve problems, and implement solutions that drive operational excellence.
Qualifications
Bachelor's degree in a relevant field such as Biotechnology, Engineering, Manufacturing or Operations Management; advanced degree preferred.
3-5 years of experience (engineer level) or 6+ years of experience (senior engineer level) in manufacturing or operations optimization, preferably in a regulated environment (e.g., pharmaceuticals, medical devices, or biotechnology).
Required: Lean certification (minimally green belt certified) - Including demonstrated experience applying Lean Six Sigma, and other operational excellence methodologies to manufacturing operations.
Experience with data analysis, process optimization, and implementation of KPIs and performance metrics.
Understanding of cell therapy manufacturing processes, regulatory requirements (GxP, GMP, FDA, EMA), or related industry standards.
Proficient in data analysis tools (Excel, Minitab, etc.), statistical process control (SPC), and process modeling techniques.
Strong understanding of Lean, Six Sigma, and other continuous improvement methodologies, certification a plus
Excellent analytical, problem-solving, and troubleshooting skills.
Strong project management skills, with the ability to handle multiple projects simultaneously.
Excellent written and verbal communication skills, with the ability to present data and findings to leadership and cross-functional teams.
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. You will also be eligible to receive pre-IPO equity, in addition to competitive 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.
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.
$119k-172k yearly est. Auto-Apply 60d+ ago
(Senior) Clinical Research Associate
Orca Bio 4.1
Remote Orca Bio 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.
Summary:In this (Senior) CRA role (depending on the candidate), you will be responsible for monitoring the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. You can be based anywhere in the U.S., although east coast is preferred. Travel expected: ~1+ site visit per week, for sites that do not permit virtual monitoring.
The role may be engaged as contractor or full-time employee, depending on business needs.
Responsibilities:
May serve as the primary monitor and main point of contact for assigned clinical sites
Conduct interim monitoring visits (IMVs) and ISF review
Review electronic medical records (EMR)/patient data
Source documentation verification (SDV) against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
Provide support to site staff including research coordinators and physicians
Assist in the development of trial materials as needed (e.g., case report forms, monitoring guidelines, site tools and training guides)
Contribute to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates
Author and submit high-quality monitoring visit reports within required timelines
Ensure completeness and accuracy of monitoring documentation in the eTMF
Desired Qualifications:
BA/BS or equivalent with a minimum of 2+ years of CRA experience (for CRA role) or 5+ years with lead monitor responsibilities (Senior)
Therapeutic experience in oncology/hematology and cell and gene therapy preferred
Prior CRA experience working directly for sponsor, ideally a start-up/or small company, with primary site ownership and independent monitoring responsibility
Strong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
Experience with Trial Master File management according to the DIA reference model
Experience operating within various site EMR/EHR systems
Experience using eTMF, EDC (IBM Zelta experience ideal), CTMS, and other vendors systems/portals
Personal Qualities:
Highly detail oriented with special attention to quality and quality control
Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
Well organized and able to work under tight deadlines
Demonstrated strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
Strong interpersonal skills, including verbal and written communication, are essential
Ability to work in a collegial and collaborative manner; independently and as part of a team
Ability to work in a fast-paced and informal startup environment
Highly tolerant and respectful of all members of our team
Strong problem-solving skills with desire to improve upon established processes
Sense of humor
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.
$72k-114k yearly est. Auto-Apply 34d ago
Cell Therapy Production Associate, Oncology, 2nd Shift
Orca Bio 4.1
Orca Bio job in Sacramento, CA
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 have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) 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.
This is a 2nd shift-based position, working on-site Monday through Friday, from 3pm to 11:30pm. The Cell Therapy Production Associate, Oncology plays a critical role in the production of Orca Bio's life-saving cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. Reporting into the assigned supervisor, commercial manufacturing, the job involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.Physical Demands
Production Associates: 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.
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.
Work Conditions
Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
Must be comfortable regularly participating in video-based meetings.
May be required to work scheduled overtime, weekends, or holidays based on business needs.
Key Responsibilities
Operate and closely monitor advanced manufacturing equipment to support the production of cutting-edge cell therapy products
Follow and execute standard operating procedures (SOPs) and batch records to perform production activities
Identify and resolve equipment or process issues, escalating to management as necessary
Complete all assigned training to maintain required technical proficiency and adhere to cGMP standards
Operate, monitor, clean, and prepare advanced automated equipment for cell processing, expansion, and filling in Grade B/C cleanroom environments. All required PPE and GMP-compliant gowning are provided by the company
Contribute to continuous improvement efforts, including manufacturing efficiency, compliance practices, and support for investigations, deviations, and change control processes
Required to participate in an on-call rotation as needed for weekend and/or holiday shifts
Minimum Qualifications
Associate degree and at least 1 year of experience in biomanufacturing, OR
High School Diploma/GED with a minimum of 2 years of biomanufacturing experience
Preferred Qualifications
Experience working in GMP-compliant environments
Involvement in investigations, deviations, and change control processes
B.S. degree in Biological or related sciences
Personal Qualities
Highly detail oriented with special attention to quality and documentation
Strong work ethic, curiosity to learn and contribute in a fast-paced, collaborative environment
Excellent interpersonal skills and ability to communicate effectively
Ability to work both independently and in a collaborative manner
Highly tolerant and respectful of all team members
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. You will also be eligible to receive pre-IPO equity, in addition to competitive 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.
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.
$32k-39k yearly est. Auto-Apply 60d+ ago
Senior Manager, Cost Accounting
Orca Bio 4.1
Orca Bio job in Menlo Park, CA
Job DescriptionMore 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 Senior Manager, Cost Accounting will lead cost accounting activities for manufacturing and operational functions within a biotechnology or pharmaceutical organization. This role is responsible for overseeing product costing, inventory valuation, COGS reporting, and cost-related controls, while supporting business scaling from clinical-stage through commercialization. The position requires strong leadership, cross-functional partnership, and deep expertise in manufacturing cost structures.Essential Duties & Key Responsibilities
Cost Accounting & Analysis
Develop, own and oversee standard costing, variance analysis, and cost allocations across manufacturing operations
Establish and maintain cost accounting policies, procedures, and internal controls
Lead and review monthly close activities related to inventory, COGS, and manufacturing variances
Support cost-of-goods-sold (COGS) analysis for clinical and commercial products
Inventory & Manufacturing Accounting
Maintain accurate inventory valuation for raw materials, WIP, and finished goods
Account for complex manufacturing processes, including batch-based and patient-specific production, where applicable
Partner with Manufacturing, Supply Chain, and R&D to understand cost drivers and improve cost accuracy
Lead physical inventory counts and cycle count programs
Ensure proper capitalization and expensing of manufacturing-related costs
Financial Reporting & Compliance
Support monthly close activities related to inventory, COGS, and manufacturing variances
Ensure compliance with GAAP, SOX (if applicable), and internal controls
Assist with audit requests related to inventory, cost accounting, and manufacturing transactions
Support implementation and maintenance of ERP and cost accounting systems
Serve as a primary point of contact for auditors on cost accounting and inventory-related matters
Budgeting & Forecasting
Assist in manufacturing cost forecasts and annual budgets
Monitor actual costs versus budget and provide variance analysis
Support long-range planning related to scale-up, tech transfer, and commercialization
Minimum Experience, Education, Certifications, Licenses
Bachelor's degree in accounting, Finance, or related field
5+ years of progressive cost accounting experience in a manufacturing, biotech, or pharmaceutical environment
Strong understanding of standard costing, inventory accounting, and variance analysis
Experience working with ERP systems - NetSuite is highly desirable
Strong Excel skills and data analysis capabilities
Strong analytical and problem-solving skills
Ability to work cross-functionally with manufacturing and operations teams
High attention to detail and accuracy
Ability to manage multiple priorities in a fast-paced environment
Preferred Qualifications
Experience in cell therapy, gene therapy, or biologics manufacturing
Knowledge of GMP manufacturing environments
CPA preferred but not required
Experience supporting clinical stage to commercial transition
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. You will 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.
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.
Job DescriptionMore 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 have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) 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 Associate Director, Supply Chain Planning leads planning and procurement functions while driving the design, implementation and optimization of manufacturing execution systems (MES) and enterprise resource planning connections across cell therapy manufacturing sites. This role ensures robust, compliant and scalable planning and procurement processes with digital systems to enable accurate, real-time visibility and uninterrupted production of clinical and commercial cell therapy products. The associate Director will partner with Manufacturing, Finance IT, Facilities and Quality to deliver a reliable planning foundation that supports operations and data-drive decision-making. Physical Demands
Production Associates: 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.
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.
Work Conditions
Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
Must be comfortable regularly participating in video-based meetings.
May be required to work scheduled overtime, weekends, or holidays based on business needs.
Key Responsibilities
Supply Planning
Lead site supply planning, production scheduling, and material planning to meet customer service and operational targets
Manage production and material capacity planning aligned with clinical and commercial demand forecasts developing and analyzing operational scenarios to support capacity and demand needs.
Ensure effective inventory strategies to maintain optimal raw material, consumable, and finished product levels.
Develop Sales & Operations Planning (S&OP) processes for cell therapy programs across internal manufacturing sites.
Facilitate relationships with internal commercial stakeholders and suppliers and vendors, where appropriate
Digital Systems
Serve as site business lead for MES and ERP system deployment, configuration, and optimization.
Partner with IT, Engineering, and other functions to define requirements, ensure seamless integration, and enable end-to-end planning functionality.
Translate planning processes into digital workflows, ensuring master data accuracy, transactional discipline, and real-time visibility.
Drive user adoption, training, and change management for MES/ERP solutions at the site.
Process Improvement & Analytics
Implement best practices in supply chain planning, leveraging system capabilities to improve forecast accuracy, scheduling efficiency, material availability, and cost competitiveness.
Establish KPIs and dashboards for planning performance, leveraging ERP/MES data for decision-making.
Identify and resolve systemic bottlenecks in planning processes through digital solutions
Team Leadership & Development
Lead, coach and develop a team of planners and system users.
Build a culture of digital fluency, continuous improvement and data-driven decision-making within the planning function. Build a culture of digital fluency, continuous improvement, and data-driven decision-making within the planning function.
Leadership
Effectively lead, mentor, and coach a direct team
Oversees the daily workflow of the department and performance to goals and deliverables
Recruits, interviews, hires, and trains new staff
Provides constructive and timely performance feedback and evaluations
Minimum Qualifications
Bachelor's degree in Supply Chain, Engineering, Life Sciences, or related fields.
5-7 years of progressive supply chain experience in biomanufacturing, cell therapies or advanced therapies.
Leadership of digital transformation initiatives including MES and ERP systems.
Strong knowledge of production planning, material requirements planning (MRP), and capacity planning within manufacturing.
Proven success leading cross-functional teams and driving operational results.
Excellent interpersonal, leadership, and communication skills.
Preferred Qualifications
Experience with autologous or allogeneic cell therapy supply chains.
Familiarity with both clinical and commercial supply chain models.
Knowledge of manufacturing, chain of identity/custody requirements, and vein-to-vein workflows.
Personal Qualities & Physical Demands
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
Strong problem-solving skills
Domestic and international travel may be required from time to time as needed (approximately 10-25%). Office and GMP warehouse/manufacturing environment.
May require occasional lifting up to 25 lbs. and gowning into cleanroom areas.
Requires sitting, standing, working in an office environment and computer use.
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. You will also be eligible to receive pre-IPO equity, in addition to competitive 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.
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.
$108k-167k yearly est. 5d ago
Senior Product Manager, Marketing
Orca Bio 4.1
Remote Orca Bio 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 Senior Product Manager, Marketing is responsible for contributing to the US promotional launch of Orca-T, Orca Bio's first commercial product. This individual will be a critical member of the Marketing and broader Commercial team, supporting workstreams to collect and interpret insights, develop tailored and actionable omnichannel APP/patient engagement strategies, shape and test brand messaging, and tactical development and deployment. Preparing for Promotional Launch Readiness, launch execution and continuous learning and development of new capabilities to support mid-to-long range brand success will be core responsibilities for this role. This individual will collaborate closely with the cross-functional Orca team including Medical Affairs, Sales, Operations, Regulatory, IT, and Legal.
Location: Preferential treatment will be given to candidates local to one of Orca Bio's offices in Menlo Park or Sacramento.Essential Duties & Key Responsibilities
Execute a comprehensive patient-centric tactical plan aligned to Brand KPIs to enable a robust promotional launch
Apply deep understanding of patient journeys, patient characteristics and unmet needs to develop innovative messaging and patient engagement strategies
Lead the design and implementation of APP/patient engagement initiatives, including patient ambassadors, patient advocacy partnerships, advisory boards, websites, social media, email, and education materials
Contribute to omnichannel deployment and optimization
Orchestrate quality engagement with the field sales team to ensure optimized delivery of messaging and assets
Effectively manage the marketing tactical budget
Lead planning and execution of complex, high visibility meetings and events, ensuring alignment with business objectives, seamless delivery and adherence to internal compliance requirements, policies and procedures
Provide strategic direction and oversight to agency and vendor partners, holding stakeholders accountable to scope, timelines, budget, and quality
Manage concurrent workstreams, applying strong project management discipline to prioritize work, mitigate risks, and resolve issues
Timely identification and appropriate escalation of issues with proposed solutions
Minimum Qualifications
Bachelor's degree in Life Sciences, Marketing, Finance, or related required; an MBA or other advanced degree is preferred
7+ years of biopharmaceutical experience, including 5+ years of commercial experience (sales, marketing, market access or insights and analytics)
Experience in hematology/oncology and marketing complex, novel products in therapeutic areas of high unmet need required
Proven ability to prioritize and manage multiple projects simultaneously, including market research, promotional tactics and message development, and associated PRC and OPDP processes
Track record of cross-functional collaboration
Willingness to travel up to 20%
Preferred Qualifications
Strong Marketing experience, including disease state education and branded strategy and tactical execution
Experience building, managing and optimizing omnichannel tactics, including digital and print media, and field force optimization
Clinically proficient in acute leukemia and bone marrow transplantation, with a track-record of collaborating with clinical and scientific experts to shape strategy and tactics
Strong business acumen and insight into HCP perception/behavior dynamics and key value drivers
Thrives in dynamic, fast-paced, ambiguous environments and champion an entrepreneurial mindset
Strong communication skills, with the ability to educate and drive alignment with internal, cross-functional stakeholders
Expertise in prioritizing and managing multiple projects simultaneously to deliver against ambitious goals
Experience working with Agency partners including developing agency briefs and creating content derivatives
Contributed to integrated customer experiences across audiences and channels
Proficiency with Veeva PromoMats
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.
$103k-142k yearly est. Auto-Apply 12d ago
Supervisor, Commercial Manufacturing, 2nd Shift
Orca Bio 4.1
Orca Bio job in Sacramento, CA
Job DescriptionMore 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 have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) 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 Supervisor, Commercial Manufacturing 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 Associates, Cell Therapy Production, Oncology to ensure timely and compliant manufacturing.
This is a 2nd shift-based position, working on-site Monday through Friday, from 3pm to 11:30 pm. Physical Demands
Production Associates: 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.
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.
Work Conditions
Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
Must be comfortable regularly participating in video-based meetings.
May be required to work scheduled overtime, weekends, or holidays based on business needs.
Key Responsibilities
Supervise and lead a team of associates, cell therapy production, oncology during assigned shift operations.
Coordinate daily manufacturing activities to meet schedule, and quality and compliance goals.
Execute and enforce cGMP-compliant SOPs, batch records, and safety procedures
Provide on-the-floor training, mentorship, and performance feedback to production staff
Monitor and troubleshoot production activities and equipment, escalating as needed
Partner with QA and QC to support in-process checks, deviation investigations, and batch record reviews
Maintain real-time, accurate documentation of manufacturing processes and equipment use
Support continuous improvement initiatives to increase reliability and efficiency.
Participate in CAPA and deviation investigations related to manufacturing activities
Minimum Qualifications
B.S. degree required in biology or related field
2+ years of supervisory or team experience is required
Strong understanding of aseptic manufacturing practices and clean room operations
Preferred Qualifications
M.S. degree in biology or related field
Prior experience in cell therapy or other advanced biologics
Familiarity with deviation investigations, CAPAs and change control processes
Personal Qualities & Physical Demands
Ability to gown and work in clean rooms and Biosafety safety cabinets
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
This position is eligible for shift-differential pay of +5%!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. You will also be eligible to receive pre-IPO equity, in addition to competitive 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.
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.
$30k-39k yearly est. 18d ago
Join Our Talent Community
Orca Bio 4.1
Orca Bio job in Menlo Park, CA
Job DescriptionMore 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 have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) 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.
Didn't find an open role that feels like the perfect fit?
We'd still like to hear from you. Orca Bio is growing fast, and we're always looking for passionate, driven people who want to help us transform the future of cell therapy at our Bay Area and Sacramento sites (and in some cases, remote/field based).
This general application is a way for you to introduce yourself to our Recruiting Team. Please submit your resume and a brief description letting us know your areas of interest and how you'd like to contribute at Orca Bio. We'll keep your information on file and reach out if something aligns now-or in the future.
Thanks for your interest in joining the pod!
What We Offer
You may be eligible to receive pre-IPO equity, in addition to:- Competitive medical, dental, and vision benefits- Flexible PTO and paid holidays- 401(k) plan- Life and accidental death & disability coverage- Parental leave benefits- Free daily lunches and snacks at our on-site locations Physical Demands
Production Associates: 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.
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.
Work Conditions
Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
Must be comfortable regularly participating in video-based meetings.
May be required to work scheduled overtime, weekends, or holidays based on business needs.
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.
$29k-48k yearly est. 7d ago
Associate Director, Market Development - Mid-West
Orca Bio 4.1
Remote Orca Bio 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.
Summary: The Associate Director, Market Development, West is a senior field-based position within the US commercial organization focused on commercial Key Opinion Leader (KOL) relationship engagement, market insight generation to inform marketing strategy, brand and disease awareness messaging, promotional speaker training and development, and key Center of Excellence (COE) profiling. Reporting to the Head of Marketing and New Product Planning, the Market Development team is a field-based extension of the Marketing team and will work closely with field Sales, Medical Affairs, and other cross-functional members of the Commercial team. They will be instrumental in facilitating COE onboarding prior to and during the Commercial launch of Orca-T, creating Brand strategy, and developing Brand tactics.
Essential Duties & Key Responsibilities
KOL Development
Design and execute KOL engagement strategy, including relationship development, message alignment and evaluation, scientific and product feedback, and targeted marketing initiatives
Assume HCP-facing responsibility for the Marketing team in influencing KOL understanding of unmet need in allo HSCT, obtain and synthesize messaging feedback, and implement positioning and messaging adjustments
Manage Commercial KOL engagement planning and execution at major congresses
Brand Strategy and Regional Marketing
Leverage KOL insights to inform Brand strategy, positioning, and messaging during the Brand Building process
Regional congress strategy and execution, KOL engagement, exhibit staffing, strategic sponsorship management, Brand Plan insight and support, advisory board content and execution.
Management of regional marketing budget
Promotional Physician Speaker Bureau
Identification, recruitment, and coaching of KOL speakers
Vendor selection and management
Content creation and PRC approval
Bureau management and program execution
Commercial COE Profiling and Insights
Identify KOL champions and lead KOL-specific scientific education and clinical alignment
Contribute to cross-functional pre-onboarding, multi-domain profiling of select ATCs
Internal Collaboration to Optimize Launch Readiness and Execution
Integration and strategic planning with regional cross-functional team, including Market Access, Medical Affairs, and Commercial Operations
Interaction with all levels of the Sales Force to ensure effective communication, alignment, prioritization and implementation of Brand tactics
Comply with all laws, regulations and policies that govern the conduct of Orca Bio activities
Minimum Qualifications
Extensive experience in hematology/oncology and allogeneic bone marrow transplant sales or marketing; field-based marketing experience preferred
Leukemia and/or bone marrow transplant clinical fluency
Academic center account experience
Launch experience
Demonstrated ability to work cross functionally with other teams
10+ years of related experience with a BA/BS degree in a related discipline, advanced degree preferred (MA/MBA/PharmD)
Ability to travel ~50% of the time (will include overnight travel)
Preferred Qualifications
Experience working in-house at a small or mid-sized biotechnology company
Experience at a company progressing from clinical stage through commercialization
Cell therapy or immune-oncology experience
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.
$84k-136k yearly est. Auto-Apply 12d ago
Senior Manager, Cost Accounting
Orca Bio 4.1
Orca Bio job in Menlo Park, CA
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 Senior Manager, Cost Accounting will lead cost accounting activities for manufacturing and operational functions within a biotechnology or pharmaceutical organization. This role is responsible for overseeing product costing, inventory valuation, COGS reporting, and cost-related controls, while supporting business scaling from clinical-stage through commercialization. The position requires strong leadership, cross-functional partnership, and deep expertise in manufacturing cost structures.
Essential Duties & Key Responsibilities
* Cost Accounting & Analysis
* Develop, own and oversee standard costing, variance analysis, and cost allocations across manufacturing operations
* Establish and maintain cost accounting policies, procedures, and internal controls
* Lead and review monthly close activities related to inventory, COGS, and manufacturing variances
* Support cost-of-goods-sold (COGS) analysis for clinical and commercial products
Inventory & Manufacturing AccountingMaintain accurate inventory valuation for raw materials, WIP, and finished goods Account for complex manufacturing processes, including batch-based and patient-specific production, where applicable Partner with Manufacturing, Supply Chain, and R&D to understand cost drivers and improve cost accuracy Lead physical inventory counts and cycle count programs Ensure proper capitalization and expensing of manufacturing-related costs
Financial Reporting & ComplianceSupport monthly close activities related to inventory, COGS, and manufacturing variances Ensure compliance with GAAP, SOX (if applicable), and internal controls Assist with audit requests related to inventory, cost accounting, and manufacturing transactions Support implementation and maintenance of ERP and cost accounting systems Serve as a primary point of contact for auditors on cost accounting and inventory-related matters
Budgeting & ForecastingAssist in manufacturing cost forecasts and annual budgets Monitor actual costs versus budget and provide variance analysis Support long-range planning related to scale-up, tech transfer, and commercialization
Minimum Experience, Education, Certifications, Licenses
* Bachelor's degree in accounting, Finance, or related field
* 5+ years of progressive cost accounting experience in a manufacturing, biotech, or pharmaceutical environment
* Strong understanding of standard costing, inventory accounting, and variance analysis
* Experience working with ERP systems - NetSuite is highly desirable
* Strong Excel skills and data analysis capabilities
* Strong analytical and problem-solving skills
* Ability to work cross-functionally with manufacturing and operations teams
* High attention to detail and accuracy
* Ability to manage multiple priorities in a fast-paced environment
Preferred Qualifications
* Experience in cell therapy, gene therapy, or biologics manufacturing
* Knowledge of GMP manufacturing environments
* CPA preferred but not required
* Experience supporting clinical stage to commercial transition
$155,000 - $175,000 a year
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. You will 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.
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.
$123k-172k yearly est. 21d ago
Supervisor, Commercial Manufacturing, 2nd Shift
Orca Bio 4.1
Orca Bio job in Sacramento, CA
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 have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) 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 Supervisor, Commercial Manufacturing 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 Associates, Cell Therapy Production, Oncology to ensure timely and compliant manufacturing.
This is a 2nd shift-based position, working on-site Monday through Friday, from 3pm to 11:30 pm.
Physical Demands
* Production Associates: 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.
* 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.
Work Conditions
* Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
* Must be comfortable regularly participating in video-based meetings.
* May be required to work scheduled overtime, weekends, or holidays based on business needs.
Key Responsibilities
* Supervise and lead a team of associates, cell therapy production, oncology during assigned shift operations.
* Coordinate daily manufacturing activities to meet schedule, and quality and compliance goals.
* Execute and enforce cGMP-compliant SOPs, batch records, and safety procedures
* Provide on-the-floor training, mentorship, and performance feedback to production staff
* Monitor and troubleshoot production activities and equipment, escalating as needed
* Partner with QA and QC to support in-process checks, deviation investigations, and batch record reviews
* Maintain real-time, accurate documentation of manufacturing processes and equipment use
* Support continuous improvement initiatives to increase reliability and efficiency.
* Participate in CAPA and deviation investigations related to manufacturing activities
Minimum Qualifications
* B.S. degree required in biology or related field
* 2+ years of supervisory or team experience is required
* Strong understanding of aseptic manufacturing practices and clean room operations
Preferred Qualifications
* M.S. degree in biology or related field
* Prior experience in cell therapy or other advanced biologics
* Familiarity with deviation investigations, CAPAs and change control processes
Personal Qualities & Physical Demands
* Ability to gown and work in clean rooms and Biosafety safety cabinets
* 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
$75,000 - $100,000 a year
This position is eligible for shift-differential pay of +5%!
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. You will also be eligible to receive pre-IPO equity, in addition to competitive 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.
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.
$30k-39k yearly est. 47d ago
Join Our Talent Community
Orca Bio 4.1
Orca Bio job in Sacramento, CA
Job DescriptionMore 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 have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) 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.
Didn't find an open role that feels like the perfect fit?
We'd still like to hear from you. Orca Bio is growing fast, and we're always looking for passionate, driven people who want to help us transform the future of cell therapy at our Bay Area and Sacramento sites (and in some cases, remote/field based).
This general application is a way for you to introduce yourself to our Recruiting Team. Please submit your resume and a brief description letting us know your areas of interest and how you'd like to contribute at Orca Bio. We'll keep your information on file and reach out if something aligns now-or in the future.
Thanks for your interest in joining the pod!
What We Offer
You may be eligible to receive pre-IPO equity, in addition to:- Competitive medical, dental, and vision benefits- Flexible PTO and paid holidays- 401(k) plan- Life and accidental death & disability coverage- Parental leave benefits- Free daily lunches and snacks at our on-site locations Physical Demands
Production Associates: 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.
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.
Work Conditions
Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
Must be comfortable regularly participating in video-based meetings.
May be required to work scheduled overtime, weekends, or holidays based on business needs.
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.
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 have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) 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 Associate Director, Supply Chain Planning leads planning and procurement functions while driving the design, implementation and optimization of manufacturing execution systems (MES) and enterprise resource planning connections across cell therapy manufacturing sites. This role ensures robust, compliant and scalable planning and procurement processes with digital systems to enable accurate, real-time visibility and uninterrupted production of clinical and commercial cell therapy products. The associate Director will partner with Manufacturing, Finance IT, Facilities and Quality to deliver a reliable planning foundation that supports operations and data-drive decision-making. Physical Demands
Production Associates: 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.
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.
Work Conditions
Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
Must be comfortable regularly participating in video-based meetings.
May be required to work scheduled overtime, weekends, or holidays based on business needs.
Key Responsibilities
Supply Planning
Lead site supply planning, production scheduling, and material planning to meet customer service and operational targets
Manage production and material capacity planning aligned with clinical and commercial demand forecasts developing and analyzing operational scenarios to support capacity and demand needs.
Ensure effective inventory strategies to maintain optimal raw material, consumable, and finished product levels.
Develop Sales & Operations Planning (S&OP) processes for cell therapy programs across internal manufacturing sites.
Facilitate relationships with internal commercial stakeholders and suppliers and vendors, where appropriate
Digital Systems
Serve as site business lead for MES and ERP system deployment, configuration, and optimization.
Partner with IT, Engineering, and other functions to define requirements, ensure seamless integration, and enable end-to-end planning functionality.
Translate planning processes into digital workflows, ensuring master data accuracy, transactional discipline, and real-time visibility.
Drive user adoption, training, and change management for MES/ERP solutions at the site.
Process Improvement & Analytics
Implement best practices in supply chain planning, leveraging system capabilities to improve forecast accuracy, scheduling efficiency, material availability, and cost competitiveness.
Establish KPIs and dashboards for planning performance, leveraging ERP/MES data for decision-making.
Identify and resolve systemic bottlenecks in planning processes through digital solutions
Team Leadership & Development
Lead, coach and develop a team of planners and system users.
Build a culture of digital fluency, continuous improvement and data-driven decision-making within the planning function. Build a culture of digital fluency, continuous improvement, and data-driven decision-making within the planning function.
Leadership
Effectively lead, mentor, and coach a direct team
Oversees the daily workflow of the department and performance to goals and deliverables
Recruits, interviews, hires, and trains new staff
Provides constructive and timely performance feedback and evaluations
Minimum Qualifications
Bachelor's degree in Supply Chain, Engineering, Life Sciences, or related fields.
5-7 years of progressive supply chain experience in biomanufacturing, cell therapies or advanced therapies.
Leadership of digital transformation initiatives including MES and ERP systems.
Strong knowledge of production planning, material requirements planning (MRP), and capacity planning within manufacturing.
Proven success leading cross-functional teams and driving operational results.
Excellent interpersonal, leadership, and communication skills.
Preferred Qualifications
Experience with autologous or allogeneic cell therapy supply chains.
Familiarity with both clinical and commercial supply chain models.
Knowledge of manufacturing, chain of identity/custody requirements, and vein-to-vein workflows.
Personal Qualities & Physical Demands
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
Strong problem-solving skills
Domestic and international travel may be required from time to time as needed (approximately 10-25%). Office and GMP warehouse/manufacturing environment.
May require occasional lifting up to 25 lbs. and gowning into cleanroom areas.
Requires sitting, standing, working in an office environment and computer use.
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. You will also be eligible to receive pre-IPO equity, in addition to competitive 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.
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.
$108k-167k yearly est. Auto-Apply 35d ago
Senior Product Manager, Marketing
Orca Bio 4.1
Orca Bio job in Sacramento, CA
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 Senior Product Manager, Marketing is responsible for contributing to the US promotional launch of Orca-T, Orca Bio's first commercial product. This individual will be a critical member of the Marketing and broader Commercial team, supporting workstreams to collect and interpret insights, develop tailored and actionable omnichannel APP/patient engagement strategies, shape and test brand messaging, and tactical development and deployment. Preparing for Promotional Launch Readiness, launch execution and continuous learning and development of new capabilities to support mid-to-long range brand success will be core responsibilities for this role. This individual will collaborate closely with the cross-functional Orca team including Medical Affairs, Sales, Operations, Regulatory, IT, and Legal.
Location: Preferential treatment will be given to candidates local to one of Orca Bio's offices in Menlo Park or Sacramento.Essential Duties & Key Responsibilities
Execute a comprehensive patient-centric tactical plan aligned to Brand KPIs to enable a robust promotional launch
Apply deep understanding of patient journeys, patient characteristics and unmet needs to develop innovative messaging and patient engagement strategies
Lead the design and implementation of APP/patient engagement initiatives, including patient ambassadors, patient advocacy partnerships, advisory boards, websites, social media, email, and education materials
Contribute to omnichannel deployment and optimization
Orchestrate quality engagement with the field sales team to ensure optimized delivery of messaging and assets
Effectively manage the marketing tactical budget
Lead planning and execution of complex, high visibility meetings and events, ensuring alignment with business objectives, seamless delivery and adherence to internal compliance requirements, policies and procedures
Provide strategic direction and oversight to agency and vendor partners, holding stakeholders accountable to scope, timelines, budget, and quality
Manage concurrent workstreams, applying strong project management discipline to prioritize work, mitigate risks, and resolve issues
Timely identification and appropriate escalation of issues with proposed solutions
Minimum Qualifications
Bachelor's degree in Life Sciences, Marketing, Finance, or related required; an MBA or other advanced degree is preferred
7+ years of biopharmaceutical experience, including 5+ years of commercial experience (sales, marketing, market access or insights and analytics)
Experience in hematology/oncology and marketing complex, novel products in therapeutic areas of high unmet need required
Proven ability to prioritize and manage multiple projects simultaneously, including market research, promotional tactics and message development, and associated PRC and OPDP processes
Track record of cross-functional collaboration
Willingness to travel up to 20%
Preferred Qualifications
Strong Marketing experience, including disease state education and branded strategy and tactical execution
Experience building, managing and optimizing omnichannel tactics, including digital and print media, and field force optimization
Clinically proficient in acute leukemia and bone marrow transplantation, with a track-record of collaborating with clinical and scientific experts to shape strategy and tactics
Strong business acumen and insight into HCP perception/behavior dynamics and key value drivers
Thrives in dynamic, fast-paced, ambiguous environments and champion an entrepreneurial mindset
Strong communication skills, with the ability to educate and drive alignment with internal, cross-functional stakeholders
Expertise in prioritizing and managing multiple projects simultaneously to deliver against ambitious goals
Experience working with Agency partners including developing agency briefs and creating content derivatives
Contributed to integrated customer experiences across audiences and channels
Proficiency with Veeva PromoMats
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.
Zippia gives an in-depth look into the details of Orca Bio, including salaries, political affiliations, employee data, and more, in order to inform job seekers about Orca Bio. The employee data is based on information from people who have self-reported their past or current employments at Orca Bio. The data on this page is also based on data sources collected from public and open data sources on the Internet and other locations, as well as proprietary data we licensed from other companies. Sources of data may include, but are not limited to, the BLS, company filings, estimates based on those filings, H1B filings, and other public and private datasets. While we have made attempts to ensure that the information displayed are correct, Zippia is not responsible for any errors or omissions or for the results obtained from the use of this information. None of the information on this page has been provided or approved by Orca Bio. The data presented on this page does not represent the view of Orca Bio and its employees or that of Zippia.
Orca Bio may also be known as or be related to Orca Bio, Orca Biosystems Inc and Orca Biosystems, Inc.