Associate Director / Director, Manufacturing

Job Summary

Oversees the management of all areas within Upstream Manufacturing (cell culture) involved in producing drug substances with the aim of achieving schedule, quality and cost objectives.

Responsibilities include:

• Leads Department staff hiring, accountable for staff training and ensures execution of timely staff evaluations. Develops an engaged and high-performing team. Provides 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.
• Serves as a mentor in developing direct reports and other leaders across the site. Serves as a role model of KBI’s Principles and Competencies.
• Directs and monitors department managers in accomplishing Manufacturing goals, consistent with established Manufacturing and safety culture and 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.
• Supports achieving optimum employee headcount and performance with least amount of overhead and raw material costs to meet annual budgetary plan.
• 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 manager/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 areas of expertise.
• Perform miscellaneous duties and projects as assigned and required.
  
  
  

Job Responsibilities

• Lead department staff hiring, ensure training compliance and oversee staff evaluations. Develop an engaged and high-performing team. Serve as a coach and mentor for reports meeting with them at a minimum frequency based on experience to assure objectives are met.
• Help in establishing department long and short-term goals and directs/monitors department managers in accomplishing goals.
• 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
  
  
  

Minimum Requirements

Knowledge, Skills, Abilities

Associate Director: Bachelor’s degree in a related scientific or engineering discipline and 7+ years industry experience (cell culture, fermentation); or 10+ years related experience and/or training; or equivalent.

Director: Bachelor’s degree in a related scientific or engineering discipline and 12+ years industry experience (cell culture, fermentation); or 15+ years related experience and/or training; or equivalent.

Ideal candidate will have broad based knowledge of Upstream processing techniques and equipment for mammalian cell culture processes. Experience with technical transfer is required. Experience working in a cGMP manufacturing environment is required.

Language Ability

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.

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.

Math Ability

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.

Physical Demands

Ability to periodically gown required attire to enter manufacturing spaces.

Computer Skills

MS Office Applications, ERP systems, EDMS systems, Electronic Quality Management Systems, statistical software

Equipment Use

Knowledge and experience operating or overseeing the use of GMP manufacturing equipment such as: 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 equipment, other production equipment, and Office Equipment

WORKING CONDITIONS

The job requires working 8 hour shifts M-F with fairly standard daytime hours. The job requires occasional movement 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.

Salary ranges:

Associate Director: $129,000 – $177,000

Director: $155,000 - $213,000

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.