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Purpose of the Position: Manage nucleic acid synthesis, purification, and analysis for research and for in vitro diagnostic (IVD) product development. Consistent with company practices, procedures and policies, organize synthetic efforts, acquire needed materials, carry out experimentation, supply synthetic materials to product R&D efforts. Transfer methods and interact with contract DNA manufacturing resources as needed to support product launches. A hands-on scientist to carry out appropriate nucleic acid chemistry investigations to support product R&D including formulation optimization, chemical, reagent or oligonucleotide stability that may be associated with medical diagnostic genetic test feasibility, development and improvement.
Essential Duties and Responsibilities (other duties may be assigned):
- Will manage the maintainance and operation of the laboratory for small to mid-scale oligonucleotide synthesis, purification and characterization for PCR oligonucleotide primers, sequences and otherwise specialty-labeled probes
- Maintain supplies to support company objectives through interaction with Assay Development staff. Outsource oligonucleotide materials and analysis when appropriate considering resources, time, and cost
- Manage and develop Chemistry area staff as needed to meet departmental requirements
- Ensure analytical processes and method development supporting significant projects are carried out consistent with corporate quality standards, goals and timelines
- Implement and maintain preparative and analytical chemistry capability for DNA lab including HPLC, gel analysis, spectrophotometry, fluorescence spectrophotometry, ion analysis, among others. Outsource analytical methods when necessary, for example, CE, Mass Spectrometry, moisture analysis (eg. Karl Fisher)
- Maintain raw material inventory, intermediate and finished materials databases and inventory and supply synthetic oligonucleotides to meet internal needs.
- Summarize work as appropriate for periodic review, internal or external reporting purposes.
- Represent work at internal and external meetings as required, and propose new strategies to address immediate and upcoming technical issues.
Supervisory Responsibilities: Supervise and develop Chemistry area staff as needed to meet departmental requirements. May train and assist others in relevant procedures, documentation methods, chemistry methodology as needed
Qualifications: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Excellent verbal and written communication skills
- Excellent organizational and planning skills
- Supervisory and personnel management / development experience
- Experience with database management, multi-task management and documentation of results in a DNA chemistry lab
- Nucleic acid synthesis, purification and analysis on computer operated, automated equipment
- Troubleshooting and repairing or coordination of repair on all standard laboratory equipment
- Managing projects with internal scientists and external organizations
- Practical knowledge of laboratory safety, hazardous waste handling and waste management
Education and Experience: B.S. with 7 to 10 years or M.S. with at least 5 years relevant industrial experience. Medical Device and/or in vitro diagnostic experience is desirable, but not required.
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with B.S./M.S. level education
Reasoning Ability: Good problem solving, judgement and decision making skill are required
Certifications, Licenses, Registrations: None required
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
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