Senior Scientist Technical Transfer

JOB REQUIREMENTS: Help us change lives At Exact Sciences, we\'re

helpingchange how the world prevents, detects and guides treatment for

cancer. We give patients and clinicians the clarity needed to make

confident decisions when they matter most. Join our team to find a

purpose-driven career, an inclusive culture, and robust benefits to

support your life while you\'re working to help others. Position

Overview The Senior Scientist, Technical Transfer role will lead variety

of technical transfer activities facilitating process and product

transfer into Operations. This position will work collaboratively with

other departments to develop, document, and implement new processes and

procedures as part of the design transfer process. This role shares

accountability for ensuring the successful implementation of new or

improved products and processes in Operations while relying on a team of

resources outside of reporting structure. Essential Duties Include, but

are not limited to, the following: Support Operations in design and

development of In Vitro Diagnostic (IVD) medical device manufacturing

processes and procedures in accordance with cGMP, ISO13485, and FDA

guidelines. Leads development and characterization of complex

formulation manufacturing processes and processing equipment for

buffers, mixtures, and/or raw materials with unique physical or chemical

attributes incorporating industry standard techniques at both small and

large scale. Leads and develops the development build plan strategy and

coordinate execution of development batches , lead Production Operators

in troubleshooting issues that arise during development manufacturing.

Leads and/or executes process development, training, and pilot scale

Manufacturing for moderate and complex processes/products as well as

complex buffers. Leads external design transfer of reagents and/or

components to contract manufacturing operations. Support Process and

Test Method Validation readiness and execution. Provides support and

review in generating Validation documentation. Responsible for

identifying critical processing parameters and critical quality

attributes. Leads troubleshooting and root cause investigation efforts

with understanding of recognized tools. Write new and edit existing

Quality System documents. Recognizes CI opportunities for the Quality

System and leads efforts. Responsible for generating/driving corrective

actions/action plans for more complex change requests/change orders,\...

For full info follow application link. We are an equal employment

opportunity employer. All qualified applicants will receive

consideration for employment without regard to age, color, creed,

disability, gender identity, national origin, protected veteran status,

race, religion, sex, sexual orientation, and any other status protected

by applicable local, state or federal law. Applicable portions of the

Company\'s affirmative action program are available to any applicant or

employee for inspection upon request. \*\*\*\*\* APPLICATION

INSTRUCTIONS: Apply Online: ipc.us/t/CD88461E33234F4C