---
title: 'Manager / Senior Manager, Business Systems at Orca Bio'
canonical: 'https://feeny.ai/job/manager-senior-manager-business-systems-orca-bio-sacramento-9kkyjptn9asw'
type: 'job'
last_seen: '2026-10-16'
---

# Manager / Senior Manager, Business Systems at Orca Bio

- **Company:** Orca Bio
- **Location:** Sacramento, CA
- **Compensation:** $140k–$180k
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-10-14
- **Last confirmed live:** 2026-10-16
- **Apply:** https://jobs.lever.co/orcabiosystems/5a7a1f72-0109-4669-958e-dec4904d6e9a

## Job description

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 commercial-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 cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

Orca Bio is seeking a hands-on Manager/Senior Manager, Business Systems to own the day-to-day administration, implementation, and roadmap of our business systems portfolio, with a strong focus on AI applications and supporting OrcaLink – Orca Bio’s Salesforce-based Chain of Custody / Chain of Identity (COC/COI) platform. Reporting to the Head of Business Systems and Architecture, this person will help manage our contracted software development teams, partner closely with business stakeholders across the company, and ensure our regulated and non-regulated systems are secure, compliant, scalable, and increasingly powered by AI and automation.

Essential Duties & Key Responsibilities

- Manage the full lifecycle of business systems requests – intake, requirements, configuration/build, testing, deployment, and post-launch support across Orca Bio’s platforms.
- Evaluate, implement, and integrate new business applications (CRM, ERP, QMS, MES, CTMS, HRIS, and similar) as Orca Bio’s commercial and enterprise footprint grows.
- Partner cross-functionally with business stakeholders and SMEs to translate business needs into scalable systems solutions.
- Support OrcaLink (our Salesforce-based COC/COI platform) in partnership with the OrcaLink platform owner and Salesforce administrators, contributing to configuration, release planning, and roadmap priorities as needed.
- Lead and complete IT assessments for OrcaLink in partnership with the internal Security team – evaluating site infrastructure, access controls, and data-handling practices, and tracking remediation to enable secure onboarding and ongoing connectivity.
- Identify, scope, and drive adoption of AI applications and automation across the business, prioritizing use cases that improve operations and reduce manual effort.
- Serve as the primary bridge between business stakeholders and the development team on AI and platform initiatives.
- Lead, mentor, and grow a small team of business systems analysts/administrators supporting commercial and enterprise systems.
- Support Computer System Validation (CSV) activities for GxP-regulated systems, including validation protocols and change control (QCCR), partnering closely with Quality and Validation teams.
- Ensure business systems comply with GxP, 21 CFR Part 11, HIPAA, and related security frameworks (ISO 27001, SOC 2, NIST) as applicable.
- Maintain systems documentation, integration architecture diagrams, and SOPs/work instructions for owned platforms.

Minimum Experience, Education, Certifications, Licenses

- Bachelor’s degree in Computer Science, Information Systems, Business, or a related field, or equivalent experience.
- 5-8+ years of experience in business systems, IT applications, or systems administration, including 3-5 years in a regulated life sciences/biotech environment.
- Experience implementing, integrating, and administering enterprise/commercial platforms (CRM, ERP, QMS, MES, CTMS, or similar).
- Hands-on experience scoping and delivering AI applications and automation, with a track record of translating business needs into requirements for technical teams and improving operational efficiency.
- Working knowledge of GxP requirements, 21 CFR Part 11, and Computer System Validation (CSV) practices.
- Experience managing or mentoring a team, or leading cross-functional project teams.
- Strong understanding of data security, access control, and audit-readiness practices.
- Excellent communication skills, with the ability to translate technical concepts for non-technical stakeholders.

## Preferred Qualifications

- Direct experience supporting a Salesforce-based patient services, commercial, or chain-of-custody platform.
- Hands-on Salesforce administration experience.
- Familiarity with the following systems/platforms: Salesforce, AWS, TrakSYS, NetSuite, MasterControl, and Veeva.
- Experience with SOX, GDPR, ISO 27001, or NIST frameworks.
- Experience in cell and gene therapy or another regulated commercial/clinical setting.

Training & Continuous Improvement:

Mandatory training will be assigned on a regular basis, and as needed. You are expected to complete all assigned training by the due date.

- Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
- Data Integrity (ALCOA+ principles)
- 21 CFR Part 11 and Computer System Validation (CSV)
- Quality Management System (QMS) training, including Change Control (QCCR), CAPA, Deviations, and Document Control
- FDA inspection readiness and regulatory compliance
- Company SOPs, policies, and applicable quality procedures
- Information security, cybersecurity, HIPAA, and confidentiality training
- Safety and Environmental Health & Safety (EHS) training applicable to office and manufacturing environments

Travel Requirements

- Occasional travel between Orca Bio sites (Menlo Park and Sacramento) and limited domestic travel as needed (approximately [0-10]%).

The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized 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.

## About Orca Bio

## Company Overview
- **One-liner**: Orca Bio is a clinical-stage biotechnology company developing high-precision cell therapies to cure blood cancer, genetic blood disorders, and autoimmune diseases without the severe side effects of traditional transplants.
- **Entity Type**: Private (Late-Stage Biotech)
- **Headquarters**: Menlo Park, California, USA
- **Founded**: 2016
- **Founders**: Not publicly available (leadership team has delivered on mission since founding)

## Core Business
- **Primary Industry**: Biotechnology / Cell Therapy / Pharmaceutical Manufacturing
- **Target Customers**: B2B — healthcare providers, transplant centers, and oncology clinics; ultimately serving patients with hematologic malignancies, genetic blood disorders, and autoimmune diseases
- **Mission Statement**: "To deliver a cure without compromise for patients through high precision cell therapies" [orcabio.com](https://orcabio.com/join-our-team/)

## Products & Services
- **Orca-T (Lead Therapy)**: Allogeneic T-cell immunotherapy designed to treat hematologic malignancies (AML, ALL, MDS, MPAL). It is a high-precision cell therapy that isolates the less than 1% of cells that provide therapeutic benefit from a standard transplant, aiming to improve survival rates while reducing risks of chronic GvHD. Received **Regenerative Medicine Advanced Therapy (RMAT)** designation and **Orphan Drug Designation** from the FDA. BLA accepted under **Priority Review** in October 2025, with a PDUFA target action date of **April 6, 2026** [siliconvalleyinvestclub.com](https://siliconvalleyinvestclub.com/companies/orca-bio/).
- **Orca-Q**: Designed to treat acute leukemias for patients without a fully matched donor.
- **OrcaSort Platform (Enabling Technology)**: Proprietary single-cell sorting and purification technology that isolates specific immune and stem cell populations at high precision and scale — the foundation enabling all Orca Bio’s therapies.
- **Other Pipeline Therapies**: Intended to treat a broad array of non-malignant blood and immune system disorders.

## Market Standing
- **Valuation**: Not publicly disclosed (privately held)
- **Total Funding**: **$542M** across 7 rounds (Seed, Series D, Series F, and others) [search results]
- **Key Funding Events**:
  - **Series F (Jan 2026)**: **$250M** led by **Lightspeed Venture Partners** [siliconvalleyinvestclub.com](https://siliconvalleyinvestclub.com/companies/orca-bio/)
  - **Series D (Jun 2020)**: **$192M** led by **Lightspeed Venture Partners** (11 investors total)
- **Annual Revenue**: **$13.5M** (estimated)
- **Notable Investors/Partners**: Lightspeed Venture Partners; clinical trial partners include City of Hope, Stanford Health Care, UC Davis, Oregon Health & Sciences University, University of Texas MD Anderson Cancer Center, Sarah Cannon Research Institute [orcabio.com](https://orcabio.com/wp-content/uploads/2022/03/orcabio-corporate-factsheet.pdf)
- **Growth Signals**:
  - Headcount grew **72.3% YoY** to **283 employees** [search results]
  - Phase 3 primary endpoint met (Feb 2025)
  - BLA under FDA Priority Review with PDUFA date April 6, 2026 — potential FDA approval and commercial launch imminent
  - 200+ patients treated in clinical trials to date
  - Ramping up manufacturing operations with multiple new hires across manufacturing, quality, and operations

## Competitive Advantages
- **Precision Cell Sorting Platform**: Orca Bio’s proprietary technology sorts the more than 100 billion cells in a standard allogeneic transplant down to the less than 1% that actually provide therapeutic benefits, creating a high-precision proprietary mixture of immune and stem cells to build a designer immune system for patients.
- **Reduced Side Effects**: Designed to control serious complications like chronic GvHD while enabling a potent anti-cancer effect — a significant improvement over traditional transplants.
- **Manufacturing Speed**: Consistently achieved donor-to-patient vein-to-vein turnaround times of less than 72 hours across ongoing clinical trials.
- **Regulatory Momentum**: RMAT designation and FDA Priority Review for lead therapy Orca-T signal strong regulatory alignment and potential for accelerated path to market.

## Strategic Focus
- **Commercialization Readiness**: With a $250M Series F raised in Dec 2025/Jan 2026 and a PDUFA date in April 2026, the company is aggressively scaling manufacturing, quality, and commercial operations to prepare for a potential product launch.
- **Manufacturing Scale-Up**: Significant hiring across manufacturing, MSAT, packaging, and cold chain handling roles in Sacramento and Menlo Park.
- **Pipeline Expansion**: Advancing Orca-Q for patients without fully matched donors and expanding into broader non-malignant blood and immune system disorders.
- **Building the Commercial Organization**: Recent hires include a Chief Commercial Officer (Mike Hirschmann) and Associate Director of Market Development (Mid-West), signaling preparation for a U.S. commercial launch.

## Why Work Here
- **Mission-Driven Impact**: "Deliver the promise of a cure, without compromise" — employees work directly on therapies that could transform the lives of patients with blood cancer and serious immune disorders [orcabio.com](https://orcabio.com/join-our-team/)
- **Start-Up Culture with Late-Stage Resources**: Described as maintaining a "start-up culture of camaraderie" while being well-funded ($542M total) and approaching a major regulatory milestone [orcabio.com](https://orcabio.com/join-our-team/)
- **Rapid Growth & Career Opportunity**: Headcount grew 72% YoY; 36 active job postings at time of research across manufacturing, quality, analytical development, and commercial roles
- **Work Environment**: On-site roles in Menlo Park, CA (HQ) and Sacramento, CA (manufacturing facility). Roles span day, night, and 2nd/3rd shifts for manufacturing positions.
- **Culture Ratings**: 3.7/5.0 overall on employer review sites (Culture: 3.9, Career: 3.7, Compensation: 3.4, Work-Life: 3.1)
- **Top Talent Sources**: Employees come from Genentech, UC Davis, Stanford, BioMarin, Cepheid, Omeros — strong biotech pedigree
- **Notable Perks**: Opportunity to work at the cutting edge of cell therapy with a platform that has real potential to change standard of care in transplant medicine

## Sources
1. [orcabio.com - Official Website](https://orcabio.com/join-our-team/)
2. [orcabio.com - Corporate Factsheet](https://orcabio.com/wp-content/uploads/2022/03/orcabio-corporate-factsheet.pdf)
3. [jobs.lever.co/orcabiosystems - Careers Page](https://jobs.lever.co/orcabiosystems)
4. [siliconvalleyinvestclub.com - Orca Bio Profile](https://siliconvalleyinvestclub.com/companies/orca-bio/)
5. [linkedin.com/company/orcabio - LinkedIn](https://linkedin.com/company/orcabio)

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