What are the responsibilities and job description for the Technical Transfer Process Lead position 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 Make
In 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
Role Responsibilities
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
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.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
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, 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
Role 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.
- B.S. in Science or Engineering with a minimum of 8 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.
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
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.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!