Manufacturing Scientist

Akkodis is looking for a Manufacturing Scientist onsite in Claymont, DE. This position requires someone who has experience with immunoassays, ELISA, lateral flow assays and/or Document Revision, NCR, or other issues with manufacturing.

The pay range is $42-50 an hour on a W2 contract to hire.[~$87k-$104k a year]. Cannot do C2C.

Job Summary

This is an experienced position. The individual is responsible for supporting the daily production and testing needs of a Reagent Manufacturing team. This includes investigation and resolution of assay failures during in-process or final testing. Including material specification changes due to new material qualification or supplier changes and updating/correcting SOPs in compliance with current quality system standards. This position will support the routine production and testing of reagents for IVD assays. All work will be in compliance with governing regulatory requirements such as FDA, ISO 13485, and QSR. Activities can include Experience with immunoassays is required, ELISA and lateral flow technology is preferred.

Principal Duties and Responsibilities:

• Provide technical expertise and direction in multiple Immunoassay manufacturing areas
• Lead multi-department teams to support/resolve non-conforming issues for existing products
• Communicate investigation status reports, proposals for further investigation, etc. via oral and written reports; develop and implement changes to existing documentation in a timely manner
• Solve immunoassay testing and manufacturing issues as they arise
• Training of laboratory personnel
• Assess manufacturing processes and systems, and implement improvements aimed at performance, quality, and cost
• Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements
• Create protocols, execute, draw conclusions and author reports
• Interpolate and analyze data using statistical analysis (including control charts)
• Create and revise standard operating procedures including periodic review.
• Manage the documentation associated with the Change Control process.
• Author review and manage quality events including NCRs, Issue Evaluations, and CAPAs.
• Understands, promotes, and enforces all applicable safety protocols including chemical, biological hazards, labeling, containment, and waste handling.
• Understand product application and customer expectations
• Work as a member of interdepartmental project teams

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Expected Areas of Competence (i.e., knowledge, skills and abilities)

• Candidates with practical experience in the development, validation and/or manufacture of diagnostic assays is required
• Work experience with ELISA assays is preferred
• ISO 13485 or cGMP experience preferred
• Proficiency in Microsoft Office software is required.
• The ability to read, interpret and analyze scientific data is required.
• The ability to effectively communicate through written and oral form is required, along with strong organizational and time management skills

Education/Experience Requirements

• Bachelor’s Degree in a scientific or engineering related field is required. Advanced degree (MS/PhD) preferred and can substitute for experience.
• Minimum 4 years of experience in a relevant production/manufacturing environment.

If you are interested in this role, then please click APPLY NOW.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance