Title: Technology Transfer Scientist
Location: Rochester NY 14626
Duration: 12 Months
Position Summary :
As our organization experiences continued growth, we are seeking Tech Transfer Support to facilitate the introduction of new products (Thermo Controls) across our diverse range of testing technologies.
The individual will be responsible for assisting with the execution and implementation activities for the launch of these new products and processes.
The individual will report to the Tech Transfer Manager and work under the guidance of a Senior Tech Transfer Scientist to help ensure that key project milestones are met.
Major Duties & Responsibilities
30% Author Tech Transfer deliverable checklists to ensure that all prequisite requirements are in place prior to manufacturing the verification (Transfer),
Validation and launch lots of products. Ensure all objective evidence and supporting evidence is obtained and meets requirements.
30% Ensure receiving site protocols and reports are aligned to the manufacturing transfer plans and that transfer and validation lots meet requirements.
25% Author /update Manufacturing Transfer Plans and Reports related to the alternate site(s)
10% Serve as liason between the current and new manufacturing locations as required.
5% Ensure that all documentation and any updated versions are provided to the alteranate manufacturing locations.
Perform other work-related duties as assigned.
Skills Required:
Degree in Chemistry, Biochemistry, Biology or similar discipline preferred or minimum of 3 years experience in an Tech Transfer, Operations or Product Development/Support role within a GMP manufacturing environment.
Minimum of 3 years experience in an Tech Transfer, Operational or Product Development/Support role within a GMP manufacutring environment.
Demonstrated ability to successfully deliver against project timelines
Track record of contributing to cross-functional teams within a regulated environment.
Knowledge of R&D and Operations (manufacturing, quality processes and systems) is required.
Ability to recommend efficient solutions to harmonize potential process changes with operational preferences.
Efficient use of common applications, such as MS Excel, is required.
cGMP and external audit experience (GMED, FDA, etc.) is strongly preferred.
Maintains an organized approach understands priorities and escalates issues appropriately.
Knowledge of Client's products and quality system is preferred.
Multi-disciplined validation experience is strongly preferred (Process, Product, Method).
Experience with Lean Manufacturing, Six Sigma and Mistake Proofing is preferred.
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