Sr Engineer II, Drug Product Process Development & Manufacturing at Biogen in Research Triangle Park, NC

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Job Description

Biogen is seeking a process engineer for leading activities for parenteral drug product development and manufacturing. This is a unique opportunity to be in a multi-functional role that covers CMC development and manufacturing of parenteral drug products. As a member of the Drug Product group, the candidate will be responsible for developing and implementing fill-finish processes, overseeing operations and troubleshooting production issues in Biogen's internal manufacturing facility. The candidate will work collaboratively with Quality and Manufacturing groups to ensure clinical supply and quality standards.

Responsibilities include:
* Lead process fit analysis, equipment testing and machinability trials in a flexible format fill-finish facility to support GMP production
* Develop filling and stoppering processes in vials, syringes and cartridges for parenteral products of multiple modalities
* Support media fills, primary packaging qualifications and new format testing activities
* As a technical SME, oversee activities in the plant during a GMP production
* Support Engineering in troubleshooting and maintain process equipment- isolator, filler, mixing vessels and control systems
* Seek operational efficiency and continuous improvement opportunities and implement process improvements
* Perform batch record review. Support manufacturing deviation, perform root cause analysis and corrective actions
* Design and execute of fill-finish process characterization studies such as freeze/thaw, mixing, filtration and aseptic filling
* Evaluate new fill-finish technologies and lead implementation in manufacturing
* Represent drug product in CMC development teams and support regulatory filings as necessary
* Presenting scientific data to technical and manufacturing teams, ability to manage several projects simultaneously, and excellent communication skills, both written and oral

Qualifications

* Prior experience with fill-finish technologies- Isolators, filling equipment, stopper processing, single -use mixers and freeze/thaw systems
* Thorough knowledge of drug product manufacturing process flow and operations such as mixing, sterile filtration and container filling/stoppering
* Ability to evaluate process and equipment set-up and parameter and design studies for optimization
* Good understanding of liquid and lyophilized drug product development and regulatory guidelines on sterile fill-finish process
* Ability to drive decisions and recommendations in cross-functional teams in a dynamic work environment with multiple projects through effective communication and engagement

BS/MS in an Engineering discipline or Pharmaceutical Sciences with 8+ years or a PhD with 2+ years industrial experience is required

Additional Information

Biogen is seeking a process engineer for leading activities for parenteral drug product development and manufacturing. This is a unique opportunity to be in a multi-functional role that covers CMC development and manufacturing of parenteral drug products.

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