Job Description

ABOUT THIS ROLE

The Manufacturing Associate II/III performs and documents daily manufacturing operations in a cGMP environment that involves operation of process equipment, execution of validation protocols, creating/ revising cGMP documents and other assignments. Highly detailed oriented with excellent documentation skills and good troubleshooting abilities. 

WHAT YOU’LL DO

• Execute manufacturing processing steps and/or manufacturing support activities
• Documents/Records and Review cGMP data and information
• Approves reviewed completed batch production records
• Investigate deviations, develops and implements corrective and preventative actions as required by supervisor
• Actively participates in training activities, managing their individual training plan
• Ability to work independently and with minimal direction
• Ability to develop schedules for the group when requested, and keeps other groups current on scheduling changes (e.g. communicates with schedules and materials management as required).

WHO YOU ARE:

If you are a highly detailed and focused individual that enjoys problem solving and team work, you are a great fit for our manufacturing 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.  

Qualifications

REQUIRED SKILLS:

MANUFACTURING ASSOCIATE II:

• High School Diploma (or equivalent) in addition to 6 months of direct experience/1 year of related experience OR
• Biowork Certificate, Associate’s Degree or Bachelor’s Degree with limited to no experience

MANUFACTURING ASSOCIATE III:

• High School Diploma (or equivalent) in addition to 1.5 years of direct experience/3 years of related experience OR
• BioWork Certificate or Associate’s Degree in addition to 1 year of direct experience/2.5 years of related experience OR
• Bachelor’s Degree with 6 months of direct experience/2 years of related experience

PREFERRED SKILLS:

• Targeted biopharmaceutical training (Bioworks or equivalent) and/or related military training preferred
• Detailed oriented with excellent documentation skills
• Strong peer and team leadership skills.
• Capable to work a 12-hour shift

Additional Information

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.