Associate Scientist- MFG, QC and Equipment

Elephas•Madison, WI

13d

About The Position

Elephas, a Madison, WI-based biotechnology start-up company, is seeking a highly motivated Scientist to support Manufacturing (MFG), Quality Control (QC), and equipment oversight within our Operations team. This individual will assist in MFG and QC of reagents and consumables utilized with our Elephas platform. This individual will support equipment preventative maintenance (PM) and calibrations (CAL) ensuring documentation is maintained in the computerized maintenance management system (CMMS). The individual will work closely with the lead scientists, technical transfer team, R&D, Quality, and Operations to ensure successful production and release of products into inventory and management of all equipment onsite. This role will utilize appropriate inhouse systems and tools to execute the production runs based on sales and operating plans (S&OP) and will work closely with outside vendors to complete all PMs and CALs where needed. This candidate will be self-motivated to learn, and comfortable in a fast-paced and highly collaborative environment.

Requirements

Bachelor’s degree in Life Sciences field or related discipline
Computer proficiency of Microsoft Office Suite
Strong attention to detail
Ability to problem solve with good analytical skills
Excellent verbal and written communication skills

Responsibilities

Assist in labeling, manufacturing, dispensing, and quality control of Elephas products
Partner with lead scientists and technical transfer team to execute manufacturing, analytical testing methods, and quality control assays for production and release of the products to inventory
Support scaling activities for manufacture of reagents, consumables, and testing methods
Follow protocols, procedures, and work instructions to support manufacturing and quality control capabilities in compliance with RUO, GMPs, FDA 21 CFR 820, and ISO13485 guidelines
Draft and review Standard Operating Procedures (SOPs) and related manufacturing process documentation as required aligned with the Quality Management System (QMS)
Assist in troubleshooting production and quality control related performance issues and out of specifications working closely with senior scientists to identify root cause and develop process improvements to reduce and mitigate risk
Support CAPAs, non-conformances, deviations, and investigations with Quality partners and Operations leaders to drive action and mitigations going forward
Follow proper lab processes and documentation including equipment use and safety practices
Comfortable working with biological and chemical materials, and instrumentation
Execute PMs and CALs as required working with outside vendors or internal employees to ensure proper documentation and completion of records and tracking in the CMMS
Support onboarding of new equipment assets into lab spaces