Sr. Manager, Manufacturing (Cell Therapy)

Employer
Nkarta Inc
Location
South San Francisco, CA, United States
Posted
Nov 03, 2020
Ref
31037
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Sr. Manager, Manufacturing (Cell Therapy)

Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off the shelf natural killer (NK) cell therapies for cancer. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies, Nkarta is building a pipeline of cell therapy candidates generated by efficient manufacturing processes, which are engineered to enhance tumor targeting and improve persistence for sustained activity in the body.

Founded in 2015 at the birthplace of biotechnology in South San Francisco, CA, Nkarta became a public company (Nasdaq symbol NKTX) in 2020. Our development pipeline of engineered NK cell therapy candidates consists of co-lead programs, NKX101 and NKX019. The IND for NKX101 for the treatment of relapsed or refractory AML and higher-risk MDS was accepted by the FDA in July 2020. Patient dosing began in Q4 2020. As we broaden the development of NKX101, we also plan to initiate studies in solid tumors. Our second co-lead program, NKX019, is designed to target B cell lymphomas. We plan to file our IND for NKX019 with the FDA in early 2021.

Position Title Sr. Manager, Manufacturing (Cell Therapy)

Reports to: Executive Director, Manufacturing

Location South San Francisco, CA

Position Summary

Nkarta seeks a highly motivated Sr MGR, Manufacturing to join our Manufacturing team. This role leads the Manufacturing team supporting our efforts in the exciting new area of cancer immunotherapy , managing a team of cell culture manufacturing specialists in a commercial pharmaceutical environment.

Key Responsibilities
• Leads and manages drug substance) and drug product contract manufacturing organizations. Activities include tech transfer, and manufacturing oversight (i.e. execution to release). Leads the internal meetings tied to each CMO for preparedness and readiness of activities.
• Leads and manages the startup of Nkarta's facility including qualification of equipment. Works with vendors on the commissioning of the equipment. Works with the internal team on the design space of the area.
• Works with a cross functional team to build the starting material for Phase 1 program
• Manages the on-the-floor operations of our commercial cell therapy manufacturing facility in a cGMP environment
• Builds a team, provides necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews
• Generates SOPs, batch records, and other quality documents for equipment and procedures used in the manufacture
• Executes production and resource schedule against operational plan
• Ensures performance of all process steps specific to the phase or stage of operation
• Processes monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements
• Completes the final review of completed manufacturing documentation per compliance standards and established timelines
• Investigates and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management
• Interacts with outside vendors and senior management
• Participates in multi-functional project teams, as necessary
• Takes corrective action to bring about required changes using change control procedures

Position Requirements
• Experience in a regulated biotech or pharmaceutical setting with proven competency and expertise in the GMP manufacture of cell-based therapies.
• Ability to build and manage a team as well as train entry-level team members.
• Knowledgeable of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's).
• Creative and comfortable with building a facility and processes from the start.
• Understanding of process, systems and equipment to troubleshoot problems.
• Strong knowledge of quality systems.
• Excellent interpersonal, verbal and written communication skills; this is a collaborative teamwork environment.
• A "Can do" attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
• Willingness to think outside of the box; adapt best practices to our small and growing environment.
• Ability to adapt in a constantly evolving environment.
• Self-motivated with a strong sense of ownership in areas of responsibility

• Willingness and ability to travel up to 20%.

• Embodies the Nkarta culture of empowerment, diversity, and inclusion.

Education / Background
• Bachelor's degree in biology or related field (or equivalent experience required), advanced degree preferred with at least 12 years of experience managing a manufacturing team in the biotechnology or biologics industry.
• Previous cell culture experience preferred

Working Environment

This position requires the ability to occasionally lift and/or move up to 25 pounds within a cell therapy manufacturing environment. Must gown in aseptic environments. Specific vision abilities for this job include close vision, depth perception, and ability to adjust focus. The common requirements of an office environment (computers, computer screens, workstations, etc.) apply when not working in or around the laboratory environment. Car and airplane travel might be requirement of this role.

About Nkarta

The 90+ team members at our South San Francisco, California headquartered location describe working at Nkarta, along with opportunities for improvement, in some of the following ways:
• "Work is interesting - lots of projects in the pipeline (so I don't have to worry about the one project failing). Leadership is open, straight forward."
• "Smart, capable, nice people. People I work with day to day are enjoyable."
• "Employee-centric."
• "I like that the company is open minded with a (people) -(looking for) a set of skills that can grow (as opposed to thinking you have to have exactly what's in a job spec now) Things that broaden their (employees) skills and growth."
• "Like any startup there are fires to put out; feel confident we have the people to control those fires."
• "Diverse people from different backgrounds."

To learn more about our work at Nkarta and the career opportunities that will drive us forward to serve patients, please visit the company's website at https://www.nkartatx.com