Technical Transfer Process Lead

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, the selected candidate will be responsible for supporting process validation and technical transfer activities as part of the Technical Transfer Process (TTP) team within the contract manufacturing business unit. The candidate's primary duties will involve contributing to multiple technical transfer projects focused on the fill and finish of pharmaceutical and biological drug products.
ROLE RESPONSIBILITIES

• Act as key technical lead for process development.
• Independently design and manage studies for process development, process optimization, scale-up, manufacturing records and technology transfer.
• Independently design studies for evaluating the robustness of the manufacturing process. These studies will serve as a baseline for the further process validation activities.
• Independently evaluate process data and perform in-depth analysis using scientific principles for evaluation of critical process parameters governing the performance of the process. Exercises judgement in selecting methods, techniques and evaluation criteria.
• Represents Tech Transfer department as subject matter expert routinely in meetings/conference calls with clients
• Works with client’s lead technical staff, department management and senior management to evaluate complex technical details pertaining to the project and defines the scope of the project.
• Makes recommendations to the business development team regarding pricing and project studies and assist in preparation of project proposals.
• Function as the Subject Matter Expert (SME) for Manufacturing processes and Technical Transfer of new products in regard to process development.
• Collaborate with analytical, production, quality and project management team and ensure timely completion of project deliverables.
• Independently review and analyze complex process data from the clinical and commercial manufacturing batches for conformity and facilitate batch release.
• Works independently and provide guidance to lower-level personnel or as a team member.
• Execute QbD (Quality by Design) experiments to support the development and characterization of new manufacturing processes.
• Independently manage multiple cross-functional projects that may require regulatory submissions.

BASIC QUALIFICATIONS

• B.S. in Science or Engineering with a minimum of 7 years of equivalent job experience.
• Strong leadership skills; high level of personal/departmental accountability and responsibility.
• Strong understanding of process design principles.
• Previous expertise with fill/finish operations, aseptic and/or isolator manufacturing, process validation/process performance qualifications, and technical writing are critical to this role. Candidate must also have excellent communication skills, both written and verbal.