Role and Responsibilities
Apply technical skills to produce manufacturing protocols which provide the standard laboratory methods used to synthesize a specific molecule, prepare BIO conjugates, and formulate, package and assemble finished goods, including: chemical reaction scheme, required reagents, equipment and instruments to be used; detailed process instructions; required analytical methods to characterize the product; and documentation and data reporting requirements. Review and interpret historical production records and current manufacturing documents to collect data and information about existing process and work directly with manufacturing scientists and department managers to determine methods, procedures, and best practices.
Write new documents based on this review and collaboration. Draft revisions to existing manufacturing protocols, SOPs and work instructions as necessary. Manufacturing documents may be written using MS Word or Excel. Requires the ability to write precise, clear instructions for highly technical manufacturing processes based on an understanding of the science, quality system requirements, and manufacturing processes. Requires familiarity with programming languages, preferably in the use of visual basic applied to automating Excel spreadsheets. Ability to use nested excel logic functions to perform variable information processing and formatting.
Requires ability to obtain, organize and interpret large amounts of data and information from existing business systems. Must have strong team skills and demonstrated ability to work with team members to share work load, track and report project status, and review work done by others to ensure accuracy. Manage creation and revision of documents in electronic document control system in accordance with quality system requirements.
Work in ERP, SKU Wizard and Change Control systems to manage creation and revision of raw material, sub-assembly and finished good SKUs as necessary to fully document current manufacturing processes that corresponds accurately to SKU set up. Must be able to work with business system teams to understand supply chain requirements that impact SKU set up.
Qualifications and Education Requirements
Minimum Bachelor’s degree in Chemistry, Biochemistry, or Bioscience with 3-4 years of Technical Writing experience in a scientific field. Demonstrated ability and/or additional experience may be considered in lieu of an undergraduate degree.
Desired skills include knowledge of organic synthesis, protein chemistry, liquid chromatography and analytical techniques such as UV-Vis, HPLC, LCMS, and NMR. Ability to follow written and verbal directions with a high level of accuracy. Must work well in a team environment, and manage multiple tasks and deliverable related to assigned work. Ability to perform data analysis and to summarize results. A general understanding of material flow through supply chains. Comfort discussing and communicating technical information accurately. Proficient in Word with ability to use embedded Excel tools within Word. Intermediate to advanced Excel skills.