Senior Director, MSAT and Technical Transfer and Process Technology

Kindeva Drug Delivery • Bridgeton, MO

89d

About The Position

In this role as the Director of Technical Transfer, Product & Process Technology (“Tech Transfer”) you are responsible for engineers, scientists, and technical professionals with expertise in aseptic/ sterile drug product formulation, vial, syringe and cartridge filling, inspection and primary packaging manufacturing activities for liquid, lyophilized and suspension products. You will oversee technical assessments for new product placement at St. Louis sites, manage product transfers, and drive continuous improvements in manufacturing science and technical processes to support client products. You will ensure clarity, alignment, and direction for the Tech Transfer team and partner functions while planning, forecasting, and managing resources to meet technical demands. Additionally, you will collaborate across functions to develop process and technology solutions. As the system owner, you will oversee media fill protocols, analytical method validation, and Product Process Qualification (PPQ) authorization. Your leadership will foster an environment of innovation by identifying, evaluating, and implementing new technologies and product improvements. You will work cross-functionally to ensure the site remains at the forefront of contemporary manufacturing science and technologies in the aseptic/sterile drug product filling environment.

Requirements

• BS/BA, MS or PhD in a relevant discipline with minimum 10 years’ experience in bio/pharmaceutical development and Aseptic manufacturing of parenteral liquid drug products in a cGMP environment.
• Extensive experience and expertise with managing multiple product technical transfers from multiple clients in a contract manufacturing organization.
• Experience/Knowledge of primary packaging from fill to finish for vials, cartridges and syringes.
• Sound understanding and experience with technology transfer concepts.
• Strong knowledge of regulatory guidance associated with process and method validation.
• Strong knowledge of lean & QbD principles in a manufacturing environment.
• Proven track record of management and leadership effectiveness.
• Experience with complex strategic planning and cross-functional project prioritization and execution.
• Strong risk assessment and management skills.
• Strong technical and communication skills: oral/written and listening.
• Computer skills (MS Office Suite, JMP statistical software, Visio, LIMS, SAP, etc).

Responsibilities

• Oversee evaluation and eventual technical transfer of new molecules and products into the site.
• Manage the interface of the Tech transfer team with Client Portfolio & Relationship Management, Technical Operations, Quality, Validation, Operations, Regulatory and related project management.
• Manage tech transfer Project Managers, Process Engineers, and analytical resources responsible for these activities.
• Drive evaluation, planning, schedule adherence and implementation of improved drug product manufacturing processes and equipment.
• Collaborate with downstream manufacturing groups to ensure product quality attributes are clearly defined and understood.
• Develop and execute strategies to improve production throughput efficiencies throughout the new product introduction phase.
• Ensure efficiency, effectiveness, and overall compliance of the tech transfer process and related systems.
• Manage key risks, priorities and oversight of tech transfer continuous improvement efforts.
• Ensure that the processes and equipment identified meet current safe manufacturing requirements.
• Provide timely and effective support to key customers across the site/enterprise.
• Develop and execute plans that enhance employee/team engagement and enable colleague performance.
• Establish and maintain a safe work environment through the application of behavior-based safety and 6S+ programs.
• Plan and manage annual departmental budget and associated program and project costs.

What This Job Offers

• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees