Position Summary
The lead manufacturing associate is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The lead manufacturing associate must follow written, approved procedures and forms to ensure all work is conducted "Right First Time" (RFT) following Good Manufacturing Practices (GMP), including good documentation practices (GDP), and/or Good Laboratory Practices (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, downstream processing equipment, and/or manufacturing support equipment. Additionally, the manufacturing associate will have knowledge of general bioprocessing equimpentn such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies. The lead manufacturing associate will use past experiences and knowledge to teach, troubleshoot, and continuously improve the daily operations of upstream or downstream manufactguring. 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 an dsenior manufacturing associates, as well as to provide status of processes and equipment to other staff members. The lead manufacturing associate must fill in when the manufacturing supervisor is not available.
Position Responsibilities
Position Requirements
Bachelors 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 or downstream unit operations required
Experience in single-use platform technology is preferred
Excellent written and verbal communication skills are required
Salary: $43.27-$52.88
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.