Manager, Downstream MS&T

Position Summary:

The PAT MS&T Manager is responsible for establishing and directing the department level activities, execution, resources and business processes for tech transfer, process engineering, process validation and pilot lab operations at the CMF site. The MS&T Manager will manage a team of Engineers and Scientists that lead tech transfer projects and will introduce new commercial programs to ensure projects are executed efficiently and in a timely manner. The MS&T Manager should demonstrate proven technical expertise in upstream or downstream biologics and have strong knowledge of industry best practices around process engineering, process validation and the pilot lab.

Position Responsibilities:

• Oversee new commercial product introduction from Stage 2 PPQ through Stage 3 CPV Process Validation and Pre-Approval Inspection (PAI)
• Establish and maintain the procedures, business processes and tools/systems for tech transfer, process engineering, process validation and laboratory activities
• Establish plans and strategies to ensure successful cGMP production by active collaboration with process development, manufacturing operations, quality and supply chain
• Manage scheduling and resources and lead staff meetings.
• Recruit and retain talent within organization. Develop plans for contractor support of short-term projects
• Represent the department during audits, client meetings and multi-disciplinary meetings with boards of health and upper management. 
• Lead multi-disciplinary projects to improve manufacturing operations, adopt new technologies, increase production revenues, reduce cost of goods, streamline practices.
• Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, promotion and disciplinary effort. Identify opportunities and provide the means for employees to pursue career growth. 

The candidate should be able to apply sound judgment and effective decision making to lead day to day operations of the group. In addition, the candidate is required to apply sound technical and management principles in order to drive tech transfer projects and department performance within defined timelines. The ability to manage multiple projects and resources is required. The candidate should have the ability to drive direction and have excellent communication skills in order to influence the department and broader business as required.

Minimum Requirements:

• BS in Science or Engineering with minimum of 9 years industry experience, Masters with 7 years industry experience, or PhD with 6 years industry experience
• Must have demonstrated biologics expertise in upstream or downstream tech transfer, processing and operations
• Expertise in cGMP production operations is required
• Expertise with technical transfer and scale up is required
• Experience with process validation and GMP compliance requirements is preferred
• Experience working in a cGMP manufacturing environment is a plus

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.