The Associate I Manufacturing Technical Operations position is responsible for issuing and coordinating Manufacturing documentation, specifically, master production records (MPRs), to support manufacturing operations. This role ensures the effective version of the MPR and all associated sample labels are issued to the manufacturing floor according to the timing outlined in the master production schedule. This position will also support Manufacturing documentation updates to work instructions and procedures as required.

The Associate II Manufacturing Technical Operations includes all responsibilities of the Associate I and additionally serves as Subject Matter Expert in site issuance activities and can identify and execute continuous improvements to the issuance and surrounding processes. They also serve as a utility player for the wider Manufacturing Technical Operations organization and support unit op owners in manufacturing documentation updates.

Who You Are:

If you have great communication skills, and you are a highly detailed and focused individual who enjoys collaborating with other teams, you would be a great fit for our Manufacturing Technical Operations Team! This position will provide you the opportunity to collaborate and innovate with a group of individuals who are all passionate about transforming patient lives.

What You’ll do:

• Follow processes defined in procedures and work instructions to independently and with collaboration from Quality Assurance issue Batch Production Records (BPR), Solution Lot Records (SLR), and any associated labels according to the site master production schedule.
• Coordinate issuance timing and communicates any issues to multiple cross-functional groups.
• Review issued MPRs and associated labels against Master Sample Matrix prior to issuing to the manufacturing floor.
• Partner with stakeholder groups to identify continuous improvement opportunities related to the MPR issuance process.
• Identify issues and brings up to management.
• Sit on teams to help with identify improvement opportunities and help to brainstorm and execute solutions.
• Provide solutions on an infrequent basis based on well-established precedents or procedures to resolve simple technical and operational problems that arise.

Required Qualifications:

Associate I: High School Diploma plus 0-2 years of relevant experience required. Associate's or Bachelor's degree strongly preferred or equivalent skilled trades or vocational training (inclusive of military experience).

Associate II: High School Diploma plus 2 or more years of relevant experience required. Associate's or Bachelor's degree strongly preferred or equivalent skilled trades or vocational training (inclusive of military experience).

Preferred Skills:

• Effective time-manager with multiple projects/tasks who prioritizes tasks for self and for the team as required to meet production timelines
• Adaptable to changing needs and demands, comfortable navigating in a changing environment
• Ability to communicate clearly and effectively any issues across cross-functional groups
• Proficient with MS Excel, Oracle and LIMS

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.