Associate Director, Upstream Manufacturing

KBI Biopharma, Inc.; North Carolina; On-site; USD 180,000 - 240,000; Full time

Job summary

KBI Biopharma, Inc. seeks an Upstream Director to oversee all upstream manufacturing for a new commercial GMP biopharmaceutical facility.

The role leads manufacturing staff and directs media prep, seed expansion, bioreactor operations, and harvest processes to achieve quality, safety, productivity and cost targets. The candidate will drive manufacturing readiness during construction, commissioning and qualification, while ensuring strict adherence to batch records and GMP.

Qualifications

• B.S. in a life sciences or engineering field or an M.S. with GMP manufacturing experience.
• 15+ years of related GMP manufacturing operations, or 13+ years with a Master’s degree.
• 7+ years of leadership/supervisory experience.
• Knowledge of cell culture or fermentation operations; single-use platform experience preferred.
• Excellent written and verbal communication; organized and proactive.

Responsibilities

• Plan, schedule, and support medium/long term upstream production tasks to meet schedules.
• Lead upstream manufacturing staff and drive process improvements and CAPAs.
• Ensure compliance with batch records, SOPs and cGMP; manage documentation and ERP activities.
• Serve as SME during audits; manage daily issue escalation and facility readiness activities.
• Maintain equipment and facilities, ensuring timely work orders and high standards.

Skills

Leadership

Cell culture

Communication

Problem solving

Education

B.S. in life sciences or engineering

M.S. in life sciences or engineering

Tools

ERP systems

EDMS

Job description

JOB SUMMARY

The upstream director will oversee the management of all areas of upstream

manufacturing involved in the startup and production at a new commercial GMP

biopharmaceutical manufacturing facility. The individual will lead upstream

manufacturing with the aim of achieving superior quality, safety, productivity and

cost objectives. The individual will lead the manufacturing readiness activities

during the construction, commissioning, and qualification of the facility. The director will oversee all upstream manufacturing staff, with manufacturing supervisors and specialists as direct reports and will report to the Director of Manufacturing.

This proven and qualified candidate will use their past experiences, depth and

knowledge of cell culture fundamentals in media preparation, seed expansion,

bioreactor operations and cell culture harvest operations to teach, troubleshoot and continuously improve the production operations. The ideal candidate will be both technically sound as well as an experienced team motivator and coach.

The individual will ensure their teams maintain strict accordance with production

batch records, SOPs and Good Manufacturing Practices. The individual will also be responsible for ensuring MRP transactions, manufacturing record reviews,

maintenance activities, and compliance documents are completed timely and

thoroughly. The individual will ensure that manufacturing records and materials are available for timely execution of activities to meet production schedules.

The individual will be responsible for managing the mid-term and long term

schedule planning for their department and be the primary point of contact for daily issue escalation.

The director will use their leadership and technical expertise to drive process

improvement initiatives, monitor processes and equipment, troubleshoot issues,

trend and track metrics and author, review and approve procedures, deviations,

CAPAs, and change controls as needed.

JOB RESPONSIBILITIES

• Plan, schedule, and support medium and long term production tasks to ensure schedule adherence. Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T and PD, QA, Maintenance and Engineering, and AFS and Microbiology.
• Ensure timely execution and review of procedures, batch documentation, logbooks, deviations, CAPAs, change controls, and completion of ERP orders. Drive requirements to ensure rapid batch disposition.
• Hire, train and develop a highly motivated and engaged high performing team. Ensure staff maintain a high level of compliance to procedures and quality expectations.
• Drive process improvement initiatives, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed. Serve as a SME during internal and external audits and inspections.
• Ensure equipment and manufacturing facilities remain in superior working order by demonstrating a clear sense of ownership, accountability, and pride by performing routine walkthroughs, setting high standards for their staff, and ensuring facility and equipment work orders are executed timely and effectively.

MINIMUM REQUIREMENTS

Knowledge, Skills, Abilities

• B.S. degree in a life sciences or engineering discipline and 15+ years’ experience in related GMP manufacturing operations or a Master’s degree and 13+ years’ experience in related GMP manufacturing operations. Level commiserate with education and experience.
• 7+ years prior leadership/supervisory experience.
• Demonstrated knowledge of cell culture or fermentation unit operations are preferred. Experience in single-use platform technology is preferred.
• Excellent written and verbal communication skills are required.
• Energetic, motivated and dynamic individual.
• Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

Language Ability

Fluent in English Language both reading and writing. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills

MS Office, ERP, EDMS, production equipment software

Equipment Use

Biosafety Cabinets, Incubators, Single Use Bioreactors, Peristaltic Pumps and Other Single Use pumps, Automated Cell Counters, Blood Gas Analyzers, Metabolite Analyzers, Scales and Balances, pH and Osmolality meters, other lab and production equipment, and office equipment.

WORKING CONDITIONS

The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee oversees staff who utilize equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards. The noise level in the environment is moderate to high.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.