Downstream Process Development Engineer – Indiana
To support the technical transfer process, investigations, and batch record generation for cGMP manufacturing and to partner with internal and external clients to design and support manufacturing processes.
- Perform facility fit evaluation, then technology transfer and scale up of Downstream protein manufacturing process in conjunction with the process development laboratory, client, manufacturing, and quality assurance
- Generate or oversee Technical Writers who generate process batch records, protocols, reports and SOPs.
- Monitor and perform process trending, real time and otherwise.
- Lead investigations and recommend corrective/preventive actions for ongoing manufacturing processes
- Develop strong working relationships with client Technical representative
- Quickly identify and resolve purification manufacturing issues
- Work as Subject Matter Expert in Downstream Processing
- Must work and interact effectively with and for others to achieve company goals
- Must strictly adhere to safety requirements
- Must meet company attendance requirements
- Must maintain company quality and quantity standards
- Must have extremely strong and effective oral and written communications throughout various levels of the organization
- Ability to work in collaborative and independent work situations and environments with minimal supervision
- Ability to quickly develop an understanding of overall operations
- Ability to train Operations personnel on new processes and technologies
- Ability to perform statistical analysis and understand statistical relevance of data
- Ability to remain calm and receptive in fast paced situations
- BS Degree in life sciences, engineering, or other applicable discipline or equivalent industry experiences, graduate degree preferred
- 3 or more years of experience in GMP manufacturing (Upstream and/or Downstream) of biopharmaceutical products or a commensurate level of experience with related products
- Excellent organization skills, self-motivation, and ability to work independently.
- Must be able to manage multiple tasks and/or priorities and easily adapt to changing situations
- Experience with Microsoft Office suite and process monitoring software
- Demonstrated ability to work cross functionally
- Knowledge of bio-pharmaceutical regulatory and cGMP requirements
- Excellent problem solving and investigational skills
- Experience with protein purification
The growing trend of monoclonal antibody discovery has inspired this company to embark on a bold new undertaking. As a proven leader in life sciences, they are bringing its legendary innovation to a groundbreaking contract biopharmaceutical manufacturing organization that will develop and manufacture mammalian cell culture-based biopharmaceuticals for pre-clinical, clinical, and commercial use. Located in an ideal setting in the heart of the Midwest, they offer an excellent compensation package in a very low cost of living area.