Operations BioChemist I Job in Saint Charles 63304, Missouri US
EMD Millipore's Bioscience Unit in
SUMMARYAssist in the transfer of new products through Oracle entry of new items, raw materials, creation of bills of materials, document reviews, assist in the production of first RD or manufacturing lots of products associated with the Multiplex/EIA product lines by carrying out basic immunoassay procedures and preparing bulk biological formulations for first RD and manufacturing production lot of multiplex/EIA kit components. This includes but is not limited to following protocols in protein chemistry and bioanalytical procedures for in-process testing. Provide technical assistance for responsibilities associated with the technology transfer process of new products.ESSENTIAL DUTIES AND RESPONSIBILITIES
- Item Master set up in Oracle
Detail oriented person needed for set up of multiple types of items, bills of materials and routings in Oracle.
- Tech Transfer Activities
Assist in activities that include but are not limited to batch record completion, document reviews, and scheduling of first production lot dispenses. This requires a high level of organization, attention to detail as well as the ability to balance multiple priorities. Applicant must be a team player with the ability to influence others positively.
- Laboratory duties include but are not limited to performing kit launch assays, conducting in-process QC assays as well as assist in special projects with RD and manufacturing of first production or manufacturing lots of multiplex/EIA components. Some laboratory experience required. Perform all tasks utilizing good laboratory practices. Employee is required to follow and complete all MMPs (Master Manufacturing Procedures), SOPs (Standard Operating Procedures) and worksheets associated with production of assigned product. This includes good documentation skills, maintaining a clean working environment and following all safety procedures.
- Promote process and procedural improvements by revising Multiplex/EIA MMPs, SOPS and worksheets where necessary under the direction of the Technology Transfer Manager and Quality Assurance Manager. May assist Technical Support with technical questions, trouble-shooting and customer complaints.
QUALIFICATIONS / EDUCATION
- Bachelor’s degree in the Life Sciences and 1 to 2 years experience in related field or a two-year degree with three or more years experience in related field.
- Experience in manufacturing environment required
- Must be organized, action-oriented and able to balance multiple priorities.- Prefer experience with Immunoassay (ELISA), multiplex and protein chemistry- Must be able to work as a team player as well as independently
- Candidate must work well with department managers and staff, to coordinate activities between various departments.
- Candidate should have a basic working knowledge of immunological assay and protein physical methods (desalting, solutions preparation and concentration determination) and protein conjugation methods.
- Candidate should be able to understand manufacturing issues and limitations in order to minimize the impact to manufacturing post launch.
