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.