Job Title:
Senior Engineer, Drug Product
This position is a great opportunity for individuals with experience in large-scale processing of biologic drug products. We are seeking a skilled and motivated individual to join our team as a Senior Engineer.
The successful candidate will have a strong understanding of regulatory requirements and guidelines, as well as hands-on experience in MSAT or process development and technology transfer. They will also possess excellent communication and problem-solving skills, and be able to work effectively in a dynamic environment.
The role involves working closely with cross-functional teams to support the technical delivery of new product introductions and tech transfer projects. The ideal candidate will have a solid understanding of continuous process improvements and be able to identify opportunities for improvement.
Responsibilities include:
* Developing process comparisons, risk assessments, and managing DP technical and manufacturing risks
* Authoring technical reports to support DP process and product characterization
* Facilitating investigations, root cause analysis for deviation resolution, data gathering/analysis, and providing technical assessments for deviations
* Initiating and leading process improvement projects, involving cross-functional teams
* Supporting the technical delivery of new product introductions and tech transfer projects
Requirements include:
* A degree in engineering or science with relevant experience in the biotech/pharmaceutical field
* Strong analytical skills and sound judgment
* Effective decision-making skills, with the ability to negotiate and balance decisions and priorities across multiple stakeholders' needs
* Proficient in MS Office: Word, Excel, Outlook, PowerPoint, MS Project, etc.
Why Work with Us?
We are committed to diversity, equity, and inclusion in the workplace and are an affirmative action employer. We welcome applications from diverse candidates who share our commitment to these values.