Maine Molecular Quality Controls, Inc. (MMQCI) is seeking an experienced product development scientist to design, develop and validate new quality control products for molecular diagnostic tests according to current Good Manufacturing Practice (cGMP). We are a small, growing company that offers opportunity to the right candidate to grow with us and join the upper level management team in the near future.

 

Primary Duties and Responsibilities

· Serve as lead scientist to design, develop and validate new quality control products for molecular diagnostic tests according to cGMP.

· Research, evaluate, and recommend new quality control products for development.

· Bring products from design to validation under Design Control according to 21CFR820 and prepare appropriate reports.

· Some supervision and leadership of other scientists on the product development team.

· Develop written protocols for manufacture and QC of developed products according to MMQCI's Quality System.

· Hands-on laboratory work including cloning, use and troubleshooting of a variety of molecular clinical assays, and quality-scored sequence analysis.

· Work with pathogens in a BSL2 environment.

 

Experience

· Experience in product development for the in vitro molecular diagnostic industry

· Experience with cGMP

· Experience with cloning using a variety of cloning techniques

· Experience with microbiology techniques including BSL2 protocols and safety requirements

· Knowledge of clinical laboratory nucleic acid testing protocols

· Understanding of quality control practices for molecular test methods and regulatory requirements

· Some management experience preferred

 

Skills and Abilities

· Well-organized

· Ability to work independently

· Ability to multitask and manage multiple priorities

· Strong problem-solving skills

· Excellent communications skills, oral and written

· Flexible; accustomed to fast-changing priorities of a small company

· Works efficiently and quickly but with attention to detail

· Strong teamwork and interpersonal skills; ability to lead

A cover letter is required.

 

Education Requirements

PhD in molecular biology, or in microbiology with molecular experience, and at least 3 years of IVD industry experience, or MS in molecular biology, or microbiology with molecular experience, and at least 6 years IVD industry experience.

 

Benefits

MMQCI is conveniently located on the coast in beautiful southern Maine, minutes from the Maine Turnpike, Portland International Jetport, and less than 2 hours from Boston. Close by are fabulous Portland restaurants, active theater groups, sandy beaches, and a plentiful supply of Maine lobsters! Many outdoor activities are easily accessible including hiking, biking, kayaking, fishing, skiing and snowshoeing.

* Medical insurance

* Dental insurance

* Vacation

* Holidays

* Sick leave

 

Apply to this position by using the contact us form on our website or by e-mailing Joan Gordon, President, at jgordon@mmqci.com

Maine Molecular Quality Controls, Inc.
10 Southgate Road
Scarborough,  Maine    04074