Supervisor, Materials and Cold Chain Operations - Night Shift

Job Description

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 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 Supervisor, Materials and Cold Chain Operations - Night Shift  is responsible for overseeing daily operations associated with material supply, material handling, cryogenic storage, and cold chain packaging and shipping of cell therapy drug products. 

This role ensures that GMP-compliant handling, storage, packaging, and distribution of materials and drug products are performed safely, accurately, and in accordance with regulatory requirements, internal procedures, and chain-of-identity/chain-of-custody controls. 

The supervisor leads a team of material handlers and cryogenic processing/packaging specialists, ensuring operational readiness, inventory control, and timely shipment of critical materials and patient-specific drug products. 

Night Shift Hours worked:

 

• 10:00 PM – 6:30 AM

• Coverage: Overnight operations, early morning handoff

 

Work Week Schedule:

 

•  Monday - Friday

 

Please note there will be on call rotation between Day Shift and Night Shift supervisors. This is to ensure coverage for the off hours (3:30pm - 10pm and weekends).

Essential Duties & Key Responsibilities:

Materials Supply:

• Ensure materials and drug product shipments align with manufacturing schedules and patient treatment timelines. 

• Coordinate activities for supplying GMP material for manufacturing, laboratory and facility operations 

• Support receipt, inspection, storage, and distribution of GMP materials. 

• Ensure proper inventory control within ERP/MES/WMS systems. 

• Ensure accurate chain-of-identity (COI) and chain-of-custody (COC) controls for patient-specific materials and drug products. 

Cold Chain Management:

• Oversee cryogenic and cold chain storage systems, including LN2 freezers and associated monitoring systems. 

• Supervise drug product cryopreservation handling and storage workflows. 

• Ensure compliant pack-out and shipment of cold chain drug products using validated shippers. 

• Coordinate shipments with couriers and logistics partners. 

• Ensure accurate chain-of-identity (COI) and chain-of-custody (COC) controls for patient-specific materials and drug products. 

Supervision:

• Ensure operations comply with: GMP (Good Manufacturing Practices), GDP (Good Distribution Practices), GTP (Good Tissue Practices) where applicable and Internal SOPs and regulatory requirements 

• Support quality investigations, deviations, CAPAs, and change controls. 

• Ensure proper documentation, batch record completion, and data integrity. 

• Support internal and external regulatory inspections and audits. 

• Supervise and develop a direct reports 

• Promote a safety-first and quality-first culture. 

• Identify and implement process improvements in material flow, inventory control, and shipping operations. 

Minimum Experience, Education, Certifications, Licenses:

• Bachelor’s degree in operations management, or supply chain plus 2 years of supervisory experience or 

• 5 years of experience in cell therapy, biologics, pharmaceutical manufacturing or warehouse / supply chain with 2 years of supervisory experience 

• Experience in material management and supply 

• Experience in cold chain operations including cryopreservation and cold chain shipments 

• Experience with Inventory management systems 

• Preferred experience with FDA and Good Manufacturing Practice (GMP) knowledge 

• Preferred experience with chain of identity and chain of custody controls. 

• Strong understanding of good documentation practices and data integrity requirements. 

Key Competencies:

• Operational leadership 

• Attention to detail and quality mindset 

• Strong organizational and planning skills 

• Ability to manage time-critical patient product shipments 

• Cross-functional communication 

• Problem solving and continuous improvement 

Reporting Structure & Authority:

• Direct reports include: Material Handlers and Handling and Cryopreservation Associates 

• Define Supervisory responsibilities:  

• • Recruits, interviews, hires, and trains new staff 

• • Oversees the daily workflow of the department 

• • Provides constructive and timely performance feedback and evaluations 

• • Resolves issues and escalates issues for support as needed 

Physical Demands:

• 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 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 environment includes: 

• • Ability to lift 25 lbs 

• • Handling of cryogenic materials (liquid nitrogen systems) 

• • May require shift, weekend, or holiday coverage to support manufacturing and patient treatment timelines. 

Travel Requirements:

This position works onsite and does not require travel. 

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

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.