Job Description

Position Summary:

The CMF MS&T Sr. 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 Sr. 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 Sr. 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. The scope of this role includes:

• 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.

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Your Duties and Responsibilities

• Establish and Direct Department Level Activities

  • Coordinate and delegate activities for the upstream MS&T team

  • Track deliverables and resolve conflicts

  • Develop staff engineers through stretch assignments, mentoring and coaching

• Technical Support and Process Engineering

  • Provide technical expertise for cGMP production runs, ensuring efficient and reliable upstream operations.

  • Oversee and support the transfer of processes from development to manufacturing, including critical process descriptions and requirement definitions for site implementation.

  • Develop and implement process validation, monitoring strategies, and documentation to ensure ongoing compliance and process stability.

• Client Communication and Requirement Definition

  • Act as the primary point of contact for clients, managing communication to clearly articulate process requirements, expectations, and modifications.

  • Facilitate client alignment on process design, transfer plans, and performance criteria, ensuring all production activities meet defined client standards.

• Equipment System Ownership

  • Support equipment lifecycle management, including procurement, commissioning, qualification, and ongoing maintenance planning.

  • Define equipment maintenance requirements, enroll new manufacturing equipment, and evaluate and respond to equipment deviations and change impacts.

• Cross-Functional Collaboration and Team Leadership

  • Lead cross-functional teams to coordinate process implementation, validation, and optimization projects.

  • Work closely with Manufacturing, Validation, QA, Facilities & Engineering, Supply Chain, IT, Automation, QC, and Process Development teams to ensure compliant, efficient process execution.

  • Drive effective collaboration to align on process goals, solve complex challenges, and implement improvements.

Your Qualifications:

• Educational Background:

  • BS in Science or Engineering with minimum of 15 years industry experience, Masters with 13 years industry experience or PhD with 11 years industry experience.
  • Must have industry-wide biologics expertise in upstream or downstream tech transfer, processing and operations
  • Extensive 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 required
  • Experience working in a cGMP manufacturing environment is a plus

• Skill and Competencies:

  • Proven expertise in biologics, specifically in upstream processing, technical transfer, and operational support.

  • Strong background in cGMP production operations is essential.

  • Demonstrated experience in technical transfer and scale-up processes.

  • Familiarity with process validation and GMP compliance requirements is highly preferred.

  • Previous experience working in a cGMP manufacturing environment is an advantage.

  • Detail-oriented and organized, with a strong commitment to quality and regulatory compliance.

  • Team-oriented mindset with experience in leading projects and cross-functional initiatives.

Salary Range: $133,000 - $183,700.

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.

About KBI:

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.

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.