***A cover letter must be included with your resume’ explaining why you are the best hire for this position.****
Purpose of the Position: The primary purpose of this position is to manage Product Development functions at BioGX, Birmingham, AL. Primary responsibilities:
1) The Research and Development Manager is responsible for managing the completion of the research and development activities of new products, product enhancements, product improvements and product transfer. Evaluates the potential and practicality of products in development and relies on experience and judgment to plan and accomplish goals.
2) Working in a design control environment, provides scientific expertise, project management skills, application of knowledge of ISO13485, CE-IVDR, and FDA regulations to ensure product design and development documentation and processes adhere to BioGX standards and governing regulations.
Possesses and applies a broad knowledge of principles, practices and procedures of field. Demonstrates product and scientific content leadership with internal and external customers. Stays current on research developments and new concepts in molecular diagnostics, giving test design perspective to sales and marketing activities associated with current or new products. Experienced with ISO 13485, CE-IVDR, and FDA QA standards and Design Control functions.
Essential Duties and Responsibilities (other duties may be assigned):
- Manage the development of BioGX real time PCR products.
- Manage Research and Development staff.
- Manage ongoing Research and Development projects.
- Manage and plan future Research and Development configurations through project scheduling, resource allocation, and materials procurement.
- Manage product development from feasibility testing to product transfer using existing Design Control procedures
Writing, reviewing, and editing of QMS processes and procedures as they relate to R&D. Review and approve/reject Product Transfer Documents (PTDs) for compliance with specifications, accuracy and completeness.
- Participate in and coordinate external and internal validation/clinical site studies and sample procurement activities.
- Ensure research and development activities are completed with adherence to regulatory requirements.
- Provide scientific expertise for Regulatory and Marketing and Sales activities associated with product launches.
- Ensures adherence to schedules and work plans.
- Provides tactical updates to R&D leadership.
Communicates and collaborates cross-functionally to achieve program goals. Review and present project progress to the Sr. Dir., of Product Development.
Supervisory Responsibilities: Manage R&D scientists to achieve objectives. Manage staff growth and development.
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.
Specialized knowledge and experience in molecular diagnostics and real-time PCR is required. Supervisory experience at junior to senior scientist levels.
- Excellent verbal and written communication skills.
- Design control, product development and launch experience.
- Performance management experience.
- Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in IVD business.
Working knowledge of cGMP and Quality Assurance systems used in IVD products. Practical experience with clinical investigations during research, development, and validation stages, the latter in support of impending regulatory submissions (510k, PMA, etc.). Demonstrated familiarity with relevant publications, patents and processes leading to such.
Education and Experience:
Ph.D. degree is required with 5 years of experience in the field, or Masters Degree with at least 10 years of direct experience working in Molecular Diagnostics area is required.
Language Skills: Must be proficient in writing, and communicating in the English language. Mathematical Skills: Must be consistent with Master’s Degree level education. Reasoning Ability: Good problem solving, judgment and decision making skills 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.
Job Type: Full-time
Pay: $1.00 – $2.00 per year
- 401(k) matching
- Dental insurance
- Disability insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
We require all employees to wear a mask while in the office or lab. BioGX furnishes our employees with meals during their working hours including snack and beverages to reduce the risk of exposure to COVID-19.
- direct experience working in Molecular Diagnostics: 5 years (Required)