Associate Scientist- MFG, QC and Equipment

Summary

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. 

Essential Duties and 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

Education/Experience/Skills

• 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

We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.