Manufacturing Associate II (Drug Substance)

Job Description

RTP’s Drug Substance Manufacturing Site is a dynamimc environment that encourages teamwork and offers an opportunity to grow and develop while impacting our patient’s lives. The Manufacturing Associate II is an entry level position that performs and documents daily manufacturing operations in a cGMP environment. Activities include the operation of process equipment, execution of validation protocols, creating/ revising cGMP documents and other assignments.

• Work in and help maintain a safe working environment
• Execute manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record and control system
• Document/Record and review cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures
• Actively participate in training activities, managing their individual training plan

If you are a highly detailed, focused individual that enjoys problem solving and team work, you could be a great fit for our manufacturing team! You’ll have the opportunity to collaborate and innovate with a group of individuals who are passionate about saving lives.

Qualifications

• 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

• Effectively contribute in a dynamic team environment
• Ability to interpret and apply GMP knowledge
• Excellent oral and written communications skills, and analytical and organizational skills.
• Willing to work evenings and weekends to accommodate production schedules.

• Targeted biopharmaceutical training (Bioworks or equivalent) and/or experience in a regulated environment or military training
• Experience with process automation systems (i.e. DeltaV).
• Proficient in Window based software. Ability to adapt to changing software programs.

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.