Production Supervisor, HPC, Marrow

About Ossium

Ossium’s mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good.

About the Production Supervisor, HPC, Marrow Job

Fixed DAY shift: Monday-Friday, 6:00 a.m.-2:30 p.m. with a 30 minute lunch break. No nights, no rotating shifts.

Onsite: Indianapolis Facility

BS or BA in a science field preferred ; high school diploma required

This position provides oversight of daily operations and training within Ossium Health’s Production group relating to the processing of donor tissue and HPC, Marrow. The Supervisor will oversee first shift staff involved in the intake, processing, and storage of donor tissue and bone marrow products for pre-clinical and clinical use. The Supervisor will ensure a safe, controlled work environment in all areas of responsibility, be aware of the site safety objectives and quality standards, and make sure they are communicated and understood by all staff. This position will report directly to the Manager of Clinical Production.

Two things are worth knowing before you apply . First, the source material is human. Marrow is recovered from donated vertebral bodies, and every donation reflects a decision made by a family and is a gift we fully honor. Second, processing a donor requires you to be fully gowned, over the head, face, hands, feet, and body, inside a cleanroom, with limited breaks.

Required Qualifications

High school diploma required

2+ years of experience managing people

4+ years of experience in manufacturing

Knowledgeable with respect to manufacturing operations in a regulated environment

Scientific aptitude and the ability to clearly and thoroughly document all work on existing forms and records

High level of attention to detail in both operations and documentation

Excellent written and oral communication skills

Capability to operate with a high level of organization and excellent time management in a dynamic startup environment

Preferred Qualifications

BS or BA in biological sciences or equivalent

Knowledgeable with respect to aseptic techniques, clean room environment, cellular and tissue processing

2+ years aseptic processing or management experience

Key Responsibilities

Oversees daily production of HPC, Marrow, including scheduling of staff and troubleshooting processing issues

Leads daily 1st shift huddles, escalating issues related to safety, quality, delivery, cost, and people during Tier 2 huddle

Regularly meets with direct reports and escalates any issues or concerns;

Performs or verifies tasks in the production of HPC, Marrow as assigned

Ensure necessary training is completed by all production staff

Provide ongoing coaching and recognition of direct staff

Review timesheets of direct reports

Review bone marrow production batch records and associated documentation

Perform allocation and authorization review for incoming donors and sample requests

Ensures production activities are performed in accordance with current Good Tissue Practices, AATB standards, and other relevant regulations

Author or assist in drafting and revising of departmental procedures

Oversee the cryopreservation and initial inventory of HPC, Marrow product and samples in freezers

Process quality monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements, and communication with production specialists regarding the monitoring of processing and product trends

Maintain the production areas and records in an inspection ready state at all times

Work with Sterile Processing team and Equipment team to monitor production equipment/tools and ensure all is kept clean, in working order, and within calibration/PM schedule

Interact with QA department to complete event reports, deviations, CAPAs, and change controls

Interact with QC department to submit sample requests and prepare reports

Interact with Management to provide updates, results, suggestions, and work area/process observations

Physical Requirements:

Must be able to work in a moderately noisy environment

Must be able to work around biohazardous materials and chemicals

Required to work the majority of the shift aseptically in a controlled environment with limited breaks. This environment requires special gowning (ie. over the head, face, hands, feet and body).

Must be able to lift, push, pull and/or carry up to 50 lbs

Must have sufficient manual dexterity, hand/finger coordination, wrist mobility, wrist stability, and grip strength to handle, feel, grasp, manipulate, and operate objects, manual and power tools, equipment, and controls safely and accurately.

Regularly required to sit, stand, walk, squat, balance, climb, stoop, kneel, crouch and reach with arms.

A pre-employment physical examination is required for this position. This examination will be conducted after a conditional offer of employment has been extended and will evaluate the candidate's ability to safely perform the essential functions listed above.

Schedule:

Full-time (40 hours per week) onsite in our Indianapolis facility

This is a salary , exempt role

Monday through Friday , 6:00 a.m. to 2:30 p.m; no nights and no rotating shifts to cover

Occasional holiday and overtime work required: Typically about one Saturday and one holiday per year, driven by donor recovery timing; overtime based on production processing needs

No weekend shifts today: As we scale toward commercial production, we expect to add weekend coverage; any change will come with significant notice and input from the operators on the floor

Room to grow. Supervisors have the ability to advance as they qualify and gain experience, with pay increases tied to milestones

We offer a full slate of employee benefits including:

Competitive salaries

Stock options

401(k) matching

Medical, dental and vision coverage

Four weeks of PTO accrued (vacation & sick time) annually + 11 company holidays

Employer paid life insurance and long term disability

Gym membership/recreational sports reimbursements

Ossium Health provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, protected veteran status, sexual orientation, gender identity, gender expression, or any other protected characteristic. Our Equal Employment Opportunity Policy Statement and the Know Your Rights: Workplace Discrimination is Illegal Poster reaffirm this commitment. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

If reasonable accommodation is needed, please contact our People Team at [email protected] or 650-285-0603. Ossium Health complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities.

Principals / direct applicants only please. Recruiters, please do not contact this job poster.

Equal Opportunity Employer/Veterans/Disabled