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Purpose of the Position: Applies knowledge of and experiences in the medical device industry to participate in the planning of design and development projects for new products including IVD (in vitro Diagnostic) medical devices in support of company’s strategic plan. Accomplishes product development and commercialization objectives, including clinical studies and FDA submissions (510k or PMA). Assists the Manufacturing and Quality Control departments with training and with planning for manufacturing readiness consistent with company policies and goals to manufacture medical devices under cGMP.
Essential Duties and Responsibilities (other duties may be assigned):
- Uses chemistry, biochemistry, and molecular biology knowledge to solve the range of development problems associated with genetic tests for the presence of specific DNA and RNA sequences.
- Supervises R&D staff, works in laboratory, participates on product transfer teams and manages technical and/or clinical performance related work with outside investigators.
- Carries out D.O.E. studies needed to establish robust PCR-based genetic test performance and uses experimental results to develop raw material requirements, product performance specifications, product packaging requirements and stability characteristics, and product’s manufacturing release test criteria.
- Disseminates research results through the publication of progress and technical reports, research manuscripts, and presentations at seminars, workshops or conferences.
- Maintains current knowledge of competitive technologies, new principles and theories relevant to product R&D and commercialization.
- Carries out administrative responsibilities related to planning, monitoring, budgeting, or managing R&D activities and staff. May hire, train, motivate and develop R&D staff.
- Acts as spokesperson to public and professional groups regarding company’s development plans, technologies and scientific results.
- Assists as needed in evaluating and securing intellectual property rights for commercially relevant discoveries.
- Ensures that all regulatory and internal policies are followed, by seeking appropriate guidance and by developing and maintaining knowledge of applicable GMP and ISO requirements related to project(s).
- Carries out feasibility and development experiments, protocols, procedures, and report writing supporting product development for timely completion of project(s).
- Coordinates with other departments to permit completion of development and technology transfer objectives in accord with design controls procedures.
- Provides leadership to technology transfer activities by establishing manufacturing and quality control procedures and specifications, and authors, co-authors or reviews procedures and/or results of method and process validations as needed.
Supervisory Responsibilities: May supervise one or more depending upon project scope
Qualifications: To perform this job successfully, an 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:
- Experience of nucleic acid, PCR-based diagnostic test product development experience.
- Experienced with DNA and RNA sample processing and sample stabilization procedures, and with BL2 procedures and safe handling of human blood and fluids to obtain purified nucleic acids for use in test procedures.
- Familiar with the use of Arrhenius and stability relationships to establish product stability claims.
- Direct experience with FDA design control procedures and participation in development, verification, validation stages of technology transfer into a GMP manufacturing unit.
- Well organized and efficient with handling multiple tasks at the same time.
- Technician supervisory experience
- Experienced with short, intermediate and longer term project planning and clinical research.
- Fluent in the use of Microsoft Word, Excel, PowerPoint.
- Excellent written and verbal communication skills
Education and Experience: The ideal candidate will have a PhD degree in Chemistry, Molecular Biology or related field. Additional field experience (5 to 10 years) is important to success in the job function.
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with PhD level education.
Reasoning Ability: Good problem solving, judgment 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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