Assoc. Scientist – Engineering
Company | Merck |
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Location | North Wales, PA, USA |
Salary | $Not Provided – $Not Provided |
Type | Full-Time |
Degrees | Bachelor’s |
Experience Level | Entry Level/New Grad, Junior |
Requirements
- BS (or expected completion within 6 months of application) in Chemical/Biochemical/Biomedical Engineering, Biotechnology, Biochemistry, Microbiology, Structural biology, or related fields
- Relevant academic, internship, co-op, or professional experience in a laboratory setting.
- Excellent oral and written communication skills
- Well-developed organizational, record-keeping, and problem-solving skills, with an attention to detail.
Responsibilities
- Executing process development in vaccine downstream processing including lab-scale process development and optimization, in-process assay support, and process scale-up/scale-down model development.
- Supporting the hands-on execution of lab-scale experiments and authoring associated technical reports and documents.
- Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing.
- Supporting assignment execution against accelerated, critical-path timelines in a right-first-time manner.
- Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure.
- Participate in and drive organizational excellence practices such as technical standards, process platforms, operational procedures.
Preferred Qualifications
- Hands-on expertise with downstream unit operations (i.e. membrane filtration, chromatography, etc.) and process development for large molecules
- Ability to understand and execute experiments independently in fulfillment of assigned program objectives in a manner that meets quality and timeline expectations
- Experience within or collaboration with analytical teams, pilot-scale, and/or manufacturing environment
- Large molecule drug substance process development, scaling (up and down) and technology transfer
- Current Good Manufacturing Practice (cGMP) awareness or experience
- Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions
- Communication of scientific information through oral presentations and written documents