Director, Technical Transfer and Process Technology

Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
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.

RESPONSIBILITIES

• Oversee evaluation and eventual technical transfer of new molecules and products into the site. This includes managing 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 for products manufactured in collaboration with key partner functions including but not limited to Manufacturing, Engineering, Quality, Supply Chain, and as required Product Management and Client Relationship & Portfolio Management.
• Collaborate with downstream manufacturing groups such that product quality attributes are clearly defined and understood and that the upstream manufacturing processes are created to ensure that these quality attributes are met.
• Develop and execute strategies to improve production throughput efficiencies throughout the new product introduction phase along with seeking opportunities to implement efficiencies of existing processes.
• 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 (i.e. validation assessments, data analysis, development materials, technology assessments, technical risk assessments, investigation support, product impact assessments, etc.)
• Develop and execute plans, aligned with site and enterprise priorities, which 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 for Tech Transfer team.
• Plan and manage annual departmental budget and associated program and project costs for which the tech Transfer team is accountable. Oversee development of new technology, technology improvement, and tech transfer-related cost and budget estimates for project, program, and site planning.

QUALIFICATIONS

• 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 is required for this position, across Liquid, suspension, lyophilization and other product types and forms used in aseptic fill environments; this includes experience with parenteral manufacturing in isolator systems utilizing single use technology for formulation and fill train.
• Extensive experience and expertise with managing multiple product technical transfers from multiple clients on in a contract manufacturing organization preferred. · Experience/Knowledge primary packaging from fill to finish for vials, cartridge sand syringes, and in the inspection, labeling and packaging of these types of containment and delivery systems.
• Sound understanding and experience with technology transfer concepts including but not limited to:

o Technology Transfer Strategy and Implementation
o Formulation Development, Process Development, Product Process Improvement
o Media Fill programs, compliance requirements, execution elements
o Process characterization and control, equipment qualification.
o Process and analytical method development and validation.

• Strong knowledge of regulatory guidance associated with process and method validation, managing submissions, particularly for manufacturing process, methods, and or facility/equipment improvements.
• Strong knowledge of lean & QbD principles in a manufacturing environment with successful application experience
• 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 (identification, mitigation, elevation, etc.)
• Strong technical and communication skills: oral/written and listening
• Computer skills (MS Office Suite, JMP statistical software, Visio, LIMS, SAP, etc

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California residents should review our Notice for California Employees and Applicants before applying.

Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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