What are the responsibilities and job description for the Associate Director of Manufacturing - (Biologics) position at KBI Biopharma?
Job Responsibilities
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.
- Lead Downstream staff hiring, oversee training and lead staff evaluations. Develop an engaged and high-performing team. Provide clear direction and balanced performance feedback; coach, develop, and challenge direct reports; Takes corrective action as necessary on a timely basis and in accordance with company policy. Ensures compliance with current federal, state and local regulations. Consults with Human Resources Department as appropriate.
- Serve as a mentor in developing direct reports and other leaders across the site. Serve as a role model of KBI’s Values.
- Directs and monitors department managers in accomplishing manufacturing goals, consistent with established manufacturing and safety procedures. Acts as liaison between department management/subordinate levels, as well as executive/department manager levels to inform personnel of communications, decisions, policies and all matters that affect their performance, attitudes and results.
- Support achieving optimum employee levels with least amount of overhead and raw material costs to meet annual budgetary plan and client budgets.
- Manages the establishment of procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards.
- Assists managers, supervisor and other senior staff members in the development and formulation of long and short-range plans, policies, programs and objectives.
- Identifies, recommends and implements changes to improve productivity and reduce cost and waste.
- May lead major projects needed to add capabilities or manufacturing capacity (e.g., Workstream lead, etc.).
- 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 step
- Perform miscellaneous duties and projects as assigned and required
- Bachelor’s degree in a related life sciences or engineering with 6 years biopharmaceutical industry experience or 8 years related experience and/or training; or equivalent.
- Ideal candidate will have broad based knowledge of Downstream processing techniques (chromatography, tangential flow filtration) and equipment.
- Experience with technical transfer is desired.
- Experience working in a cGMP manufacturing environment is required,
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, and customers.
- 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 perform process calculations to complete technical transfer analysis including but not limited to mass balances, cycle analysis, feed rate calculations, ratio determinations, and step yields.
- Ability to use MS Project, Visio, Word, E-mail, Excel, MS Office Applications, ERP systems, EDMS systems, Electronic Quality Management Systems, statistical software
- Knowledge and experience operating or overseeing the use of GMP manufacturing equipment such as: Biosafety Cabinets, chromatography system including Unicorn software, TFF system, Peristaltic Pumps and Other Single Use pumps, Scales and Balances, pH and Osmolality meters, Other lab equipment, other production equipment
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.
