Scientist II, QC Support, MSAT

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

This position will serve as the technical expert for the Technology Transfer Process for Quality Control Lab methods and serve as a liaison between the client, the QC lab, and the operations department at the West Chester site to ensure compliance with global standards, regulations, and cGMPs. In addition, the role will represent Resilience in various industry groups dealing with analytical, and general laboratory issues.

Job Responsibilities

Partner with the QC lab to develop and maintain QC processes and systems

Serves as the technical leader for MSAT on QC methods and processes

Partners with QC to train the team on new procedures, and/or processes.

1Develop or Support transfer, development and qualification of new methods and processes.

Answer compliance and process questions from others, including regulatory agencies.

Facilitates and leads initiatives using new technologies, new policies, or new procedures to improve QC functions.

Liaison between the client, operations, and QC operations team during the tech transfer phase.

May serve as primary contact for contract services including 3rd party laboratory testing during the Tech Transfer phase.

Serve as SME for certain analytical techniques/instrumentation/equipment/procedures

Minimum Requirements
Extensive experience in pharmaceutical industry
Proven proficiency in solving complex technical problems
Demonstrated knowledge of cGMP as defined by 21CFR, Combination Drugs and EU Regulations
Strong project management skills
Demonstrate understanding of Analytical laboratory regulatory issues
Proficiency with analytical instrumentation including HPLC
Strong technical writing skills and proficiency with MS Word and Office
Experience with coaching, mentoring and training analysts.

Preferred Background
Bachelor's degree in chemistry or a similar field

> 10 years experience in a Quality control laboratory
Previous experience in method transfer and method verification
Experience with medical device testing
Experience with laboratory investigations

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.