Upstream MSAT Process Engineer/Scientist Opportunities - HYBRID
*Multiple mid-level and senior positions available; level of role is dependent on experience*
Our client is a Global Pharmaceutical CDMO existing for over a century that works with nonclinical and clinical research as well as capsule development. Their key focus is in scientific innovation and manufacturing technology to streamline the latest in pharmaceuticals. The company strives to eliminate emerging threats from the core, to empower healthy lives. Being such a robust and established organization, they push for internal growth and mobility for career advancement.
Overview:
The position is an opportunity to work within a rapidly growing Upstream Manufacturing Science and Technology (MSAT) Team. The Process Engineer/Scientist would be the SME for Upstream activities and manufacturing processes. Because there are a wide array of seniority levels open, it is an opportunity for someone with various levels of experience to enter a MSAT role focusing on the Upstream aseptic technique and mammalian cell culture.
Responsibilities:
- Represent the MSAT team on technology transfer project teams as the SME for communications customer technical and quality representatives.
- Author/Review/Own related documentation example process description and batch records.
- Author/Review change controls and manage implementation as assigned to agent.
- Present on the monitoring and reporting on process performance data.
- Process support, process tech transfer, manufacturing support.
- There is NO lab work associated with this positions.
Possible tasks:
- Process fit assessment & assessing customers to see what their needs are.
- Creation of all process documentation for tech transfer (batch records, gap analysis, raw materials, testing/compendial requirements).
- Training of operations & act as tech consultants to manufacturing floor.
- Real time process monitoring & on call support for events on the floor.
- Assess deviations (impact of event on product quality).
- Once process is completed support batch release.
- Customer facing (joining tech team meetings, part of cross functional teams at site).
- Within each asset, mix of clinical and commercial processes.
Required:
- At least 5 years of related pharmaceutical/biotech industry experience
- Mammalian cell culture
- Bioreactor Operation
- Scale-Up
- Tech Transfer
- Aseptic Technique
- Manufacturing operations knowledge
