R&D Lab Supervisor, Level III
1 week ago
Maine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and markets unique quality control products used by hospital laboratories to monitor the accuracy of tests for inherited disease, pharmacogenetics, oncology, and infectious diseases. MMQCI also provides custom products to IVD manufacturers for test development, internal QC and kit controls. MMQCI has developed technologies to stabilize DNA and RNA for use as quality controls and continues to pursue the discovery of novel techniques useful for the development of new quality control products. We are a growing company that offers a relaxed but challenging work environment with opportunities to gain experience using the latest molecular biology tools.
Do you like to experiment with DNA and RNA?? Are you familiar with the chemistry of nucleic acid?? We are seeking an eager scientist to help oversee and maintain the day-to-day efficiency of the R&D lab, mentoring team members throughout the day, while leading product support and development activities.
Primary Duties and Responsibilities:
- Conducts a wide variety of complex laboratory procedures and analyses using manual molecular biology techniques and instrumentation. Identifies experimental problems and inconsistencies and troubleshoots these problems based on learned knowledge and skills.
- Provides daily supervision of all lab areas for the R&D team. Oversees the daily assignments and supervision of the R&D Associate Scientists and Laboratory Assistants to support logistics of the R&D team. Acts as the first contact point for non-technical problem resolution.
- Leads product support, and development activities to help diagnose and troubleshoot technical issues for various products either in development or post-launch in accordance to current Good Manufacturing Practice (cGMP) following design control according to FDA 21CFR820, ISO13485 regulations and according to MMQCI’s Quality System. This includes overseeing and supporting validations, root cause investigations and product improvements.
- Initiates and maintains accurate, concise, clear documentation of all Design and Development work, including customer requirements, data, experimental plans, design review meeting notes and reports. Documentation must be adequate for FDA 510K submission and Quality Audits.
- Maintains a deep understanding of product knowledge and their functionalities. Stay up-to-date with products and changes to provide support to investigations for customer technical support. Thoroughly understands clinical laboratory practices, standards and guidelines to ensure development is in alignment with voice of customer.
- Establishes, validates, performs, troubleshoots and interprets a variety of molecular clinical assays used in the development and qc testing of MMQCI products.
- Works closely with the R&D Scientist III, Project and Technical Leads to assist with scheduling conflicts and resource allocation to help ensure on time project deliverables with support and guidance from the R&D Manager.
- Sets standards for work quality, environmental cleanliness and organization, and oversees training of new team members to those expectations.
- Coordinates with team members to understand lab inventory needs to help set min/max stocking levels to support the Lab Assistant in ordering, maintenances and stocking of laboratory supplies.
- Monitor performance of laboratory activities to provide feedback to the manager and to be the first point of contact for personnel, logistics and scheduling issues for the R&D Associate Scientist and Laboratory Assistants.
- May work with pathogens in a BSL2 environment.
Required Qualifications:
Education
B.A. or B.S., M.S. or PhD in biology, chemistry or molecular biology and a minimum of 4-5 years of experience in product development.
Experience
- Experience in molecular diagnostic product development and a familiarity with MMQCI products or clinical lab molecular testing.
- Experience with general molecular biology techniques including cloning, sequencing, amplification and electrophoresis is highly desired
- Experience leading teams through problem resolution, implementing changes, and mentoring team members.
- Supervisory experienced preferred.
Skills and Abilities
- Ability to efficiently perform laboratory procedures accurately and reproducibly.
- Able to problem-solve independently
- Well-organized with strong, clear communication skills, verbal and written, necessary for the documentation and presentation of results and communicating with all team members.
- Flexible; accustomed to fast-changing priorities
- Works efficiently and quickly but with attention to detail
- Strong teamwork and interpersonal skills
- Strong work ethic
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills of personnel so classified.
Location: MMQCI is conveniently located in beautiful southern coastal Maine, minutes from the Maine Turnpike, Portland International Jetport, and less than 2 hours from Boston. Close by are fabulous Portland restaurants, sandy beaches, and a plentiful supply of Maine lobsters Many terrific outdoor activities are easily accessible including hiking, biking, kayaking, fishing, skiing and snowshoeing. Our beautiful state-of-the-art facility is conveniently located in Saco, right next to the Eastern Trail. Come join us
Benefits:
• Medical insurance
• Dental insurance
• 401(k)
• Profit sharing plan
• Vacation
• Holidays
• Sick leave
Contact Information:Human Resources
HR@mmqci.com
Maine Molecular Quality Controls, Inc.
23 Mill Brook Road
Mill Brook Business Park
Saco, Maine 04072
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