Associate Director, Upstream Manufacturing

KBI Biopharma, Inc.; Durham (NC); On-site; USD 180,000 - 230,000; Full time

Job summary

KBI Biopharma, Inc. is seeking an Upstream Director to oversee all upstream manufacturing activities at a new GMP biopharmaceutical facility.

The role drives quality, safety, productivity and cost objectives while guiding media preparation, seed expansion, bioreactor operations and harvest processes. The successful candidate will manage staff, ensure compliance with batch records and SOPs, lead capital projects, schedule planning and continuous improvement initiatives, and mentor a

Qualifications

• B.S. in life sciences or engineering with 15+ years GMP manufacturing ops, or a Master's with 13+ years.
• 7+ years of leadership or supervisory experience.
• Cell culture or fermentation operations knowledge preferred.
• Single-use platform technology experience preferred.
• Excellent written and verbal communication skills.

Responsibilities

• Plan, schedule and support medium and long term production tasks to meet the schedule.
• Hire, train and develop a motivated, high-performing team.
• Lead audits, change controls, CAPAs and ensure cGMP compliance.
• Drive process improvements and troubleshoot equipment and processes.
• Ensure readiness during construction, commissioning and qualification.

Skills

Leadership

GMP

Cell culture

Process improvement

Team coaching

Education

B.S. in Life Sciences or Engineering

M.S. in Life Sciences or Engineering

Tools

ERP

EDMS

MS Office

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

• 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.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged. If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.

Please Note: To 3rd Party Search Firms/Employment Agencies: All inquiries must be directed to [e-mail]. Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position. KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement.