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22 days old

Manufacturing and Development Manager

Kelly Services
Evanston, IL 60201
**Manufacturing and Development Manager, Diagnostics**


Were seeking a Manufacturing and Development Manager (Medical Devices) to join a leading biotechnology client in Evanston, IL. This is a great opportunity for someone with management experience and at least 5 years of industry experience in a cGMP/FDA/ISO 13845 regulated environment. The successful candidate will oversee all aspects of kit manufacturing and work cross-functionally with R&D, Assay Development, Quality, Regulatory Affairs, vendors, and contract manufacturers. If you have extensive molecular biology skills and leadership ability, apply today! Local candidates highly considered.


**Responsibilities**


+ Oversee design transfer from R&D to Manufacturing

+ Maintain active BOMs for each product

+ Produce and manage plans, reports, specifications, SOPs, forms, and other documentation to support Manufacturing and/or Manufacturing Development activities

+ Ensure processes, documents, materials and equipment are in compliance with applicable regulatory requirements including ISO13485, ISO 14971 and cGMP

+ Generate batch records

+ Work closely with QA to maintain compliance

+ Lead process validation related activities for the design, qualification and continued process verification of Resolution Bioscience manufacturing process, including identification of opportunities for improvement.

+ Lead the generation, maintenance and coordination of the Master Validation Plan.

+ Participates in investigations related to Nonconformance and/or Corrective and Preventive Actions related to manufacturing.

+ Participates in investigations related to Product Complaints.

+ Coordinates Contract Manufacturer periodic meetings to review project progress and drive the resolution of any nonconformities.

+ Support Regulatory Submissions

+ Ensuring the schedules of the people, facility, equipment, materials, and documents are established and maintained to support manufacturing activities

+ Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective products to patients

+ Generating, reviewing, and approving documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports.

+ Ensuring deviations, CAPA, document change controls, process transfers, and pFMEAs are supported


**Qualifications:**


+ Requires a Bachelors Degree in Biochemistry, Microbiology, Molecular and Cellular Biology, or Biology or related discipline

+ 4+ years of relevant experience with supervisory or management experience

+ 4+ years of relevant experience working under FDA QSR/ISO 13485 and GMP regulations

+ Extensive experience with molecular biology techniques

+ Experience with risk assessment ISO 14971 preferred

+ Strong data analysis and troubleshooting skills

+ Familiarity with auditing practices

+ Experience with IQ/OQ/PQ

+ Familiarity with Manufacturing Engineering (Bills of Material, Batch Sizes, Costing, etc.)

+ Strong organizational and communication skills, including technical writing


_Fast track the process and apply today! Qualified talent will be contacted within 24 hrs._


**If youre unable to apply through the website, please email your resume in Word format and position title to JEND557@kellyscientific.com.**


_Kelly Science & Clinical is the premier destination for Scientific Professionals seeking Direct-Hire, Temp-to-Hire, and Contract positions across the country. Scientific Recruiters are ready to select and represent the best candidates to join their award winning scientific clients._


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-03 Expires: 2021-10-04

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Manufacturing and Development Manager

Kelly Services
Evanston, IL 60201

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