Technical Services Scientist – 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 Upstream protein manufacturing process (Mammalian cell culture) in conjunction with the process development laboratory, client, manufacturing, and quality assurance.
- Perform facility fit evaluation, then technology transfer and scale up of Upstream protein manufacturing process (Mammalian cell culture) 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/preventative actions for ongoing manufacturing processes
- Develop strong relationship with Technical representative
- Quickly identify and resolve upstream (Mammalian cell culture) manufacturing processes
- Must strictly adhere to safety requirements
- Must meet company attendance requirements
- Must maintain company quality and quantity standards
- Must have 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 remain calm and receptive in fast paced situations
- BA/BS degree in life sciences, engineering, or other applicable discipline or equivalent industry experiences, graduate degree preferred
- 5 or more years of experience in GMP manufacturing of biopharmaceutical products or a commensurate level of experience with related products
- Be able to manage multiple tasks and/or priorities and easily adapt to changing situations
- Experience with downstream process development or tech transfer or manufacturing operation
- Good problem solving and investigational skills
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.