Job Description

WHO WE ARE

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

THE ROSLINCT WAY

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE

The Materials Management Specialist will perform all activities supporting manufacturing operations, product shipping, material receiving, cryo-storage and preservation, inventory control, kitting, and MS&T support to ensure materials are supplied in a timely manner, the inventory is accurate, and manufacturing operations proceed in compliance with all Quality Systems and GMP requirements.

How You Will Make an Impact:

· Perform and maintain timely execution of PO Receipt processing for all deliveries, both GMP and non-GMP materials, in our ERP system.

· Collaborate with QC staff on all GMP inventory requiring incoming inspection.

· Periodic review and edit to core departmental SOP’s and Work Instructions to ensure compliance to cGMP standards.

o Coordinate with team on Change Control and procedural revisions for critical SOP’s and work instructions as applicable.

· Receive incoming shipments of all materials and equipment per established procedures.

· Movement and transaction of GMP materials to support production operations.

· Perform patient material receipt and outgoing shipping responsibilities as assigned.

· Ensure QC samples are accurately labeled, packed out and shipped per established procedures.

· Prepare and deliver raw materials, samples, supplies, etc. to various departments as needed ensuring proper procedures and temperature conditions are observed.

· Maintain accurate inventory of GMP material for the following functions:

o Perform inventory cycle counts, and related ERP transactions.

o Perform Expired Materials review and disposition transactions.

o Execute all transactions related to RoslinCT shipping activities.

· Escalate inventory discrepancies to Manager and SC Ops as appropriate.

· Maintain adherence to all safety procedures and GMP requirements.

· Ensure all material management workspaces remain inspection ready.

· Ensure individual employee training is current and up to date.

· Other duties as assigned.

What You Will Bring:

· A highly organized work style that ensures timely execution of tasks.

· A mindset that ensures accurate results.

· Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).

· Effective problem-solving capabilities.

· Strong oral and written communication skills.

· Prior experience with critical temperature-controlled Materials (2-8⁰C, -20⁰C, -80⁰, as well as LN2)

· Proficiency with administrative Quality and Compliance elements:

o Support execution on tasks associated with Deviation and CAPA investigations and subsequent closing actions.

Qualifications:

· 3 – 5 Years dedicated experience within Supply Chain, Materials Management or Warehouse operations role within Bio-pharma industry.

· 5 - 7 years’ experience in cGMP related industry or equivalent business.

· Established aptitude and work ethic in support of inspection-ready state and conditions for assigned responsibilities and designated work area(s).

· Bachelor’s degree with 5 years of related experience, or associate’s degree with 8 years of related experience preferred.

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal-opportunity employer, we seek to create a welcoming

and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

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