Technical Transfer Process Lead - Kindeva Drug Delivery : Job Details

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Join to apply for the Technical Transfer Process Lead role at Kindeva Drug Delivery

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 MakeIn this role, you will be responsible for auditing aseptic processes to ensure compliance with established specifications, procedures, cGMPs, and FDA regulations, while identifying any non-conformances. You will need strong written and verbal communication skills, as well as the ability to collaborate effectively across multiple departments to drive key initiatives. Additionally, you will work closely with personnel at all levels of the organization, including peers, operations staff, supervisors, and managers. Success in this role requires the ability to perform job-related tasks independently and at a high level, without direct supervision

Our Work MattersAt Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.The Impact You Will MakeIn this role, you will be responsible for auditing aseptic processes to ensure compliance with established specifications, procedures, cGMPs, and FDA regulations, while identifying any non-conformances. You will need strong written and verbal communication skills, as well as the ability to collaborate effectively across multiple departments to drive key initiatives. Additionally, you will work closely with personnel at all levels of the organization, including peers, operations staff, supervisors, and managers. Success in this role requires the ability to perform job-related tasks independently and at a high level, without direct supervisionRole Responsibilities

• Function as the Subject Matter Expert (SME) for Manufacturing processes and Technical Transfer of new products in regard to process development.
• Independently design and manage studies for process development, process optimization, scale-up, manufacturing records and technology transfer.
• Represents Tech Transfer department as subject matter expert routinely in meetings/conference calls with clients
• Responsible for the development of manufacturing production records and protocols for execution in support of qualifications, developmental/technical transfer projects, or for clinical and commercial manufacturing
• Provide training to managers and production/laboratory staff for protocol requirements and new manufacturing processes.
• Effectively present complex technical information to guide decision making.
• Write and revise SOPs and Master Plans and apply CGMP and CGDP to all areas of work.

Basic Qualifications

• B.S. in Science or Engineering with a minimum of 12 years of equivalent job experience.
• Strong understanding of process design principles.
• Experience with drug product manufacturing processes development, process scale-up and optimization.
• Ability to perform well under tight timelines and excellent decision-making quality under pressure is desired.
• Data evaluation and interpretation, including statistics and process controls.
• Experience and knowledge of sterile processing principles (aseptic or isolator technology).
• Regulatory background in pharmaceutical development/research is a plus.

California residents should review our Notice for California Employees and Applicants before applying.Equal Opportunity EmployerKindeva 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.Do you see yourself as part of the Kindeva mission? Click Apply Now Today!

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionEngineering and Information Technology
• IndustriesPharmaceutical Manufacturing

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