Hollow Fiber Principal Scientist-Engineer

6 days ago


Marlborough, United States Repligen Full time
Overview

The principal scientist will be primarily responsible for all technical aspects of hollow fiber spinning & quality control process to obtain and meet overall hollow fiber product specifications. The successful candidate will be a hands-on person who works through the manufacturing team to implement process adjustments to meet planned schedules. Candidate must be detail oriented, communicate clearly, train team, and drive efficiency. Good understanding of product usage by GMP customers so that your team understands importance of what they do. You will also have responsibility for creation of documentation and the maintenance of that documentation in an ISO regulated plant. The successful candidate will actively collaborate with personnel at all levels of within the organization.

Responsibilities

Essential Duties and Responsibilities:

* Manage/Provide leadership to all aspects of hollow fiber manufacturing, testing and documentation.

* Work closely with the membrane manufacturing, engineering, and quality control teams, dedicating considerable time to hands-on work in the operational areas.

* Provide technical understanding to a multi-shift manufacturing team who operate over a 24 x7 schedule.

* Lead process validation efforts for all new product introductions and provide support to manufacturing with any issues that arise.

* Drive Continuous improvement in quality and throughput leading to increased yield, improved efficiencies, and reduced process variability.

* Sound approach to problem solving aligned to business and quality requirements.

* Methodical problem solver, skilled in data analysis utilizing statistical tools.

* Provide training or presentations as needed in support team goals and objectives.

* Provide mentorship, team guidance, and succession planning.

* Communicate effectively with engineering staff and cross functional departments.

* Align with the Repligen's EHS (Environmental Health & Safety) culture to foster a safe work environment and strive for continuous improvement.

Qualifications

Education and/or Work Experience Requirements:

* BS or MS in Chemical engineering, Polymer Chemistry, Material Science or relevant discipline and 7-10 years of experience in membrane development or membrane manufacturing.

* Extensive hands-on experience in the hollow fiber spinning process, coupled with comprehensive expertise in the critical process parameters that govern hollow fiber membrane spinning process.

* Good technical knowledge of performance specification for UF and MF hollow fiber membranes and ability to relate the specifications to hollow fiber spinning process.

* Experience in method development and operation of various analytical instruments (e.g. Spectroscopy, HPLC, Karl-Fisher titrator), and membrane characterization tools (e.g. SEM, porometer).

* A demonstrated history for meeting demanding production timelines within the framework of an ISO/GMP environment.

* Communicates to a multi-shift seven-day manufacturing team.

* Meticulous mindset.

* Strong written and verbal communication skills with ability to delegate tasks.

* Proficiency with standard business software is required (Office 365, Teams, etc.)

* Able to balance changing priorities with increasing workload by making timely decisions.

* Able to interact with employees at all levels and cross functionally across multiple departments.

* Lead by example and adhere to safety protocols, safe work practices, and wearing appropriate PPE (Personal Protective Equipment).

Physical Requirements:

Must be capable of lifting 50 pounds routinely.

PDN-9d85f625-1d4e-4e62-ae05-d8eb361c1993

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