- Manufacturing Science is a partner of biologics manufacturing operations and is the custodian of manufacturing processes. Manufacturing Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.
- Provide collocated technical leadership at manufacturing sites including process monitoring,
CPV, root cause investigation, change assessment, debottlenecking, and continuous
- Anticipate, respond to, and permanently resolve issues that arise during production.
- Aid in design of new processes and facilities with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis.
- Lead the creation and use of digital process data analytic systems.
- Partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements.
- Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
- Reviews manufacturing processes and/or development and production data
- Designs and conducts necessary experiments, interprets results
- Recommends changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.
- Trains manufacturing staff on new or changed processes and the use of equipment.
- May provide technical guidance to less experienced staff.
- Interacts with colleagues from various functions, such as Engineering, Manufacturing, and
- May lead small technical project teams and implement project plans.
- May lead technology transfer efforts of small project teams between groups/organizations.
- Bachelor’s Degree in engineering or science with 3 years of experience
OR Master’s degree in engineering or science with 1 year of experience
- **Seeking looking for someone with a degree in Chemical or Biochemical Engineering, or related engineering discipline.
- **Prior experience with biopharmaceutical production a plus
- Proficient in Microsoft Word, Excel, and PowerPoint
- Experience in biotechnology or the pharmaceutical industry
- Experience in purification, cell culture, or analytical methods
- Familiarity with root cause analysis and/or risk assessment
- Knowledge of DeltaV automation
- Experience working with statistical analysis software
- Experience with project leadership, communicating with cross functional teams
- Effective communication skills and strong technical writing skills
- Experience with high level data analysis
- Ability to lift weight, gown up and gain entry to manufacturing areas
- Ability to manage timelines and work with multidisciplinary teams **highly preferred
- Coding experience or desire to learn coding.
- This job will be remote until allowed onsite. At which point, it is still uncertain whether it will be fully onsite or if we transition to a hybrid working structure.