Principal Scientist – Cell Culture

Desired Skills: cell culture,biopharmaceutical,manufacturing

PE Global is currently recruiting for a Principal Scientist on behalf of our client based in North Dublin: 12 month initial contract

Our clients Multi Product Cell Culture (MPCC) Facility is seeking to recruit a contract upstream and/or downstream Manufacturing Support Scientist. The Manufacturing Support group (in MS&T) are responsible for continued process technical support to the cell culture, primary recovery and downstream unit operations for the commercial manufacture of multiple mammalian cell culture processes in the Multi Product Cell Culture facility. The successful candidate will be key contributor to this dynamic and highly technical team. This position will build collaborations with Manufacturing, Manufacturing Science & Technology (MS&T), Upstream and Downstream teams, Engineering, Quality Assurance, Quality Control and Global Regulatory Sciences groups to name a few.

Key Responsibilities

• Have a thorough knowledge of the science behind each molecule and associated drug substance manufacturing processes with fundamental knowledge of one or more of the following relevant principles:

o Upstream (Cell Culture Focus) including media preparation, large scale cell culture bulk drug substance manufacturing processing (vial thaw, scale up, single use systems, seed and production bioreactors and harvest centrifugation/clarification).

o Downstream (Purification Focus): to include buffer preparation, purification and viral reduction steps, including chromatography, ultrafiltration, viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill.

• To identify and implement process improvements, e.g. yield, cycle time reduction through evaluation of process performance using data analytics tools.
• Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies (e.g. health authority query support – timely responses / data gathering etc.), representing the site.
• To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution.
• Identify or support process improvements (through change control or CAPA) and participate in implementation of Lean initiatives at site.
• Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
• To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
• Document and appropriately communicate aspects of work and learnings at internal and external fora (may include participation at scientific meetings).

Qualifications & Experience

• Minimum BSc or equivalent with at least 6 years’ experience in drug substance manufacturing technical support in the biopharmaceutical industry.
• You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
• Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings.
• Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
• Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements.

Please note that this role may infrequently require periods of extended hours or a modified work schedule and may require on-call availability

On-site Protocol

Physical presence at the worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

Please note that this role may infrequently require periods of extended hours or a modified work schedule and may require on-call availability

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV to audrey.mccarthy@peglobal.net