A multi-product cell culture manufacturing facility is seeking to recruit a Downstream Manufacturing Support Scientist. The Manufacturing Support group, within Manufacturing Science & Technology (MS&T), is responsible for providing continued process and technical support to cell culture, primary recovery, and downstream unit operations for the commercial manufacture of multiple mammalian cell culture processes.
The successful candidate will be a key contributor to a dynamic and highly technical team and will build strong collaborations with Manufacturing, MS&T, Upstream and Downstream teams, Engineering, Quality Assurance, Quality Control, and Global Regulatory groups.
Key Responsibilities
* Maintain a thorough understanding of the science behind each molecule and associated drug substance manufacturing processes, with strong technical knowledge in one or more of the following areas:
- Upstream (Cell Culture Focus): Media preparation, large-scale mammalian cell culture processing, vial thaw, scale-up activities, single-use systems, seed and production bioreactors, and harvest centrifugation/clarification.
- Downstream (Purification Focus): Buffer preparation, purification and viral reduction operations, including chromatography, ultrafiltration, viral reduction filtration, viral inactivation technologies, drug substance formulation, and bulk fill.
* Identify and implement process improvements such as yield enhancement and cycle time reduction through evaluation of process performance using data analytics tools.
* Provide process subject matter expertise during regulatory inspections and interactions with health authorities, including preparation of responses and data packages.
* Deliver on-the-floor technical support for troubleshooting manufacturing issues and lead investigations into process deviations and resolutions.
* Identify and support process improvements through change controls and CAPAs and participate in the implementation of Lean and continuous improvement initiatives.
* Author and review technical documentation, including protocols, reports, and SOPs supporting process validation activities.
* Generate and execute plant-supporting studies and technical studies at commercial manufacturing scale.
* Document and communicate technical learnings and outcomes within internal forums and, where appropriate, external scientific meetings.
Qualifications & Experience
* Minimum BSc or equivalent with at least 6 years' experience providing technical support within drug substance manufacturing in the biopharmaceutical industry.
* Demonstrated understanding of cGMP compliance and regulatory agency requirements, with strong technical writing and communication skills.
* Proven ability to work effectively in cross-functional, matrixed, and global team environments.
* Ability to develop, present, and defend technical and scientific approaches both verbally and in writing.
* Strong stakeholder management skills with the ability to influence technical decisions while balancing product quality and operational requirements.
This role may occasionally require extended hours, modified work schedules, or on-call support.
On-site Requirement
Physical presence on site is a core requirement of this role to support collaboration, operational effectiveness, and manufacturing support activities.
