Lead Manufacturing Associate

The Lead Manufacturing Associate is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. This position is for a 2,2,3 pitman day shift schedule starting at 6:00 AM to 6:30 PM.

The Lead Manufacturing Associate must follow written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) following Good Manufacturing Practice (GMP), including good documentation practices, and/or Good Laboratory Practice (GLP). As needed, the Lead Manufacturing Associate will work individually or on teams to author standard operating procedures (SOPs) or Master Batch Records (MBRs); write corrective and preventive actions (CAPAs); and specify, commission, and qualify new equipment.

The Lead Manufacturing Associate will be responsible for upstream unit operations (seed expansion, bioreactor operations, cell culture harvest), downstream unit operations (chromatography, tangential flow filtration, viral inactivation, and bulk filling) and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave) activities. The Lead Manufacturing Associate will have past experience and a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment), downstream processing equipment (mixing vessels, chromatography, tangential flow filters, virus filters), and/or manufacturing support equipment (mixing vessels, parts washers, and autoclaves). Additionally, the manufacturing associate will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). The Lead Manufacturing Associate will use past experiences and knowledge to teach, troubleshoot and continuously improve the daily operations of upstream or downstream manufacturing. The Lead Manufacturing Associate will promote and enforce precise and compliant operations, while maintaining a sense of ownership of the production processes, the manufacturing environment, and the facility.

The Lead Manufacturing Associate will be expected to review the manufacturing schedule, executed manufacturing documentation, and ERP orders to ensure compliant operations and schedule adherence. Staff will effectively communicate questions, concerns, or deviations to management and the quality system according to KBI internal notification processes.

The Lead Manufacturing Associate must be able to provide direction/guidance to Manufacturing Associates and Senior Manufacturing Associates; as well as to provide detailed status of processes and equipment to other staff members. The Lead Manufacturing Associate must fill in when the Manufacturing Supervisor is not available.

Responsibility- Approximate % of Time

Manufacture bulk intermediates and drug substances per manufacturing batch records and in compliance with quality standards, company policies and current regulations. 20%

Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures. Ensure each task listed in production records (i.e. SRs, EPRs, and BRs) is completed following GxP’s at the time of execution. 15%

Ensure that the team is performing pre-execution and post-execution review of their records; as well as reviewing batch records prior to submitting for departmental review. This includes the issuance and accountability of applicable items during the execution of a record (i.e. SR, EPR and BR).15%

Demonstrate, apply, and ensure understanding of current Good Manufacturing Practice and how they apply to specific tasks and responsibilities. 10%

Provide direction/guidance to Manufacturing Associates and Senior Manufacturing Associates. Help supervisor to distribute the workload and ensure others understand the requirements of their tasks. Check with team members throughout the shift to make sure that assigned tasks are completed in a timely fashion. 10%

Check schedule and try to identify and assign any tasks that could be pulled from next shift, and/or ensure everything the next shift will need is ready for them. Set them up for success. 10%

Participate and be accountable for workplace organization (5S). 10%

Ensure additional tasks assigned by Supervisor are completed during shift (i.e. trainings). 10%

Bachelor’s degree in a related scientific or engineering discipline with 6 years’ experience in related GMP manufacturing operations; or a high school diploma with 12 years’ experience in related GMP manufacturing operations.

• Basic knowledge of upstream (cell culture or fermentation) or downstream (purification and bulk filling) unit operations is 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 fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
  
  
  

Salary: $40.39 - $55.53/hour

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

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.