Downstream Manufacturing Manager/ Senior Manager

• Ensures schedule adherence for tasks including but not limited to manufacturing, qualification, and maintenance activities.
• Actively participate as a role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor.
• Staff selection, training, oversight, performance evaluations, and development.
• Ensures standard operating procedures are accurate for executing unit operations, batch record review & MRP transactions are completed accurately meeting disposition timelines, trend and track departmental metrics, and non-conformances are initiated and closed with right the first-time documentation.
• Reviews technical documents, change controls, solution records and batch records for accuracy, thoroughness and regulatory compliance.
• Elevate critical and impactful events to Director/Sr. Management.
• Utilizes leadership and technical expertise to make real time processing decisions, monitors processes and equipment.
• Troubleshoot and perform initial assessment of events that have the potential to impact area safety and product quality.

• Assists area manager with the implementation of long and short-range plans, policies, programs and objectives.
• Identifies, recommends and implements changes to improve productivity and reduce cost and waste.
• This proven and qualified candidate will serve as a subject matter expert (SME) as required during regulatory inspections for deviations, change controls, and process documentation. Make decisions as a SME on mammalian large scale production processes especially for chromatography and tangential flow filtration.
• Perform miscellaneous duties and projects as assigned and required
• Plan, schedule, oversee, and support long and short-range plans, 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.
• Supervise, coach, mentor and train team members to maintain educated, qualified and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations.
• Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders. Ensure timely corrections to batch documentation and logbooks.
• Drive process improvement initiatives, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed.
• Ensure equipment and manufacturing facilities remain in working order by overseeing production technician maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair.

Requirements:

• Bachelor's Degree in Chemical / Biochemical / Biological Engineering or related discipline with 10+ years of experience in a GLP, GMP and/or ICH/GCP environment or High School Diploma with 15+ years of experience in a GLP, GMP, and/ or ICH/GCP environment
• 4+ years of experience leading a team, managing others directly or indirectly
• Mechanical ability/expertise coupled with a solid technical background of purification processes and equipment, strong knowledge of GMP practices preferred.
• Excellent organization, technical writing and communication skills.
• Energetic and motivated individual with the ability to multi-task and meet aggressive deadlines for clinical and commercial production.
• Experience in single-use platform technology is preferred.
• 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.
• 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.
• Ability to develop and solve algebraic and exponential math problems by hand or using software.
• Ability to apply basic statistics to sets of values and develop and interpret different types of graphs.
• Ability to use MS Office, ERP, EDMS, production equipment software, other
• Ability to use Chromatography system including Unicorn software, Biosafety Cabinets, Incubators, Peristaltic Pumps and Other Single Use pumps, Scales and Balances, pH and Osmolality meters, other lab equipment, other production equipment, and office equipment
• The job requires working 8-hour shifts on a Monday through Friday schedule. Some flexibility will be required for interaction across both day and night shifts.
• The job requires on call availability after hours and on weekends.
• 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.

Range: $118,000.00 / yr - $162,800.00 / yr

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.