Kindeva Drug Delivery · 2 weeks ago
Senior Director, MSAT and Technical Transfer and Process Technology
St. Louis County, MO
Full-time
Onsite
Director/Executive
10+ years expKindeva Drug Delivery is a company focused on creating products that save lives and improve patient health globally. The Senior Director of MSAT and Technical Transfer and Process Technology will lead a team of technical professionals in overseeing the technical transfer of drug products and drive continuous improvements in manufacturing processes. This role involves collaboration across functions to ensure compliance and efficiency in aseptic drug product filling.
Manufacturing
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
Qualification
Required
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: Technology Transfer Strategy and Implementation, Formulation Development, Process Development, Product Process Improvement, Media Fill programs, compliance requirements, execution elements, Process characterization and control, equipment qualification, 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)
Company
Kindeva Drug Delivery
Kindeva Drug Delivery is a global contract development and manufacturing organization (CDMO) in the pharmaceutical industry.
1001-5000 employees
H1B Sponsorship
Kindeva Drug Delivery has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (4)
2023 (1)
2022 (3)
Funding
Current Stage
Late StageTotal Funding
$46.96MKey Investors
Global Britain Investment Fund
2023-08-03Grant· $41.96M
2022-11-14Acquired
2022-06-13Series Unknown· $5M
Leadership Team
Brian Schubmehl
Chief Human Resources Officer
Recent News
MarketScreener
2026-01-01
Company data provided by crunchbase