R&D Scientist II – MOLECULAR DIAGNOSTICS
Saco, ME
Full Time
Experienced
R&D Scientist II – MOLECULAR DIAGNOSTICS
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, 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.
We are seeking an eager scientist to provide support to various projects for new product development and validation of quality control products for clinical molecular diagnostic tests.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Education
B.A. or B.S. in biology, chemistry or relevant experience and a minimum of 3-5 years of experience in a relevant discipline or PhD with 1-2 years’ experience.
Experience
BENEFITS:
Contact Information:
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, 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.
We are seeking an eager scientist to provide support to various projects for new product development and validation of quality control products for clinical molecular diagnostic tests.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Conducts complex laboratory procedures and analyses using a variety of manual molecular biology techniques and instrumentation. Identifies experimental problems and inconsistencies and troubleshoots these problems based on learned knowledge and skills.
- Designs, develops, validates and manufactures new quality control products for various molecular diagnostic tests under the guidance of the R&D Scientist III and Manager of R&D in accordance to current Good Manufacturing Practice (cGMP) following design control according to FDA 21CFR820, ISO13485 regulations and according to MMQCI’s Quality System. Creates appropriate reports and documentation adequate for FDA 510K submission and Quality Audits.
- Designs optimal sequences and engineers’ complex DNA constructs through the use of public data bases to be used as targets in the development of control products.
- Collaborates and communicates frequently with MMQCI staff to ensure on-time delivery of the development of products of the highest quality.
- Organizes data, interprets results and makes suggestions for future experiments and product improvements.
- Establishes, validates, performs and interprets a variety of molecular clinical assays including various types of amplification technologies, as well as, detailed sequence analysis using alignment software such as Geneious Prime.
- Stays current in literature relevant to molecular techniques and quality control practices of clinical laboratories in order to maintain and broaden knowledge in project areas.
- Participates in technical writing to support submissions of abstracts, posters and scientific articles for publication or presentation at technical conferences.
- May attend scientific conferences in order to identify clinically relevant candidates for MMQCI’s product pipeline, network with other scientists, learn about new equipment by speaking with vendors, assess competition, and, overall, represent the scientific face of MMQCI.
- Provides training of other MMQCI personnel in areas of expertise. Participates as a role model to inspire and encourage innovation and drive technology advancements. May also participate in the training of undergraduate and summer students.
- May work with pathogens in a BSL2 environment.
Education
B.A. or B.S. in biology, chemistry or relevant experience and a minimum of 3-5 years of experience in a relevant discipline or PhD with 1-2 years’ experience.
Experience
- Sufficient knowledge in general molecular biology techniques including cloning, sequencing, amplification and electrophoresis is required.
- Previous product development experience or experience working within a GMP facility is preferred.
- Well-organized
- Ability to perform laboratory procedures accurately and reproducibly
- Works efficiently but with attention to detail
- Strong work ethic
- Strong communication skills, verbal and written, necessary for the presentation of results and issues to collaborators and all level of team members.
- Ability to innovate
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.
BENEFITS:
- Medical insurance
- Dental insurance
- 401(k)
- Profit sharing plan
- Vacation
- Holidays
- Sick leave
Contact Information:
Human Resources Maine Molecular Quality Controls, Inc. 23 Mill Brook Road Mill Brook Business Park Saco, Maine 04072 [email protected] |
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