R&D Scientist II

Department: Research and Development

Reports To: R&D Manager

FLSA Status: Non-Exempt

Employee Type: Full-Time

Hours: 40 hours/week Monday - Friday

8:00 am – 5:00 pm (30 minutes for lunch and 30 minutes for a break)

Note: Nights and weekends can be approved by manager.

Summary

The R&D Scientist II provides technical and scientific leadership to support new product development, troubleshooting and optimization of process and analytical methods, and technical communications with customers and suppliers. Identifies and implements new methods, equipment, and technologies. Effectively performs the following duties:

Essential Duties & Responsibilities

1. New product development with the assistance of more experienced R&D Scientists: evaluates published

literature and provides technical and economic analysis of product feasibility, performs experimental work to

develop, optimize, scale up, and validate new production or analytical procedures, creates documents

(SOPs, protocols, reports) needed for implementation of the new processes, and assists in scale up and

transfer of new processes to other departments.

2. Learns and performs design control procedures and documentation.

3. Troubleshooting and optimization: assists production and other departments with troubleshooting

problematic production issues. Also assists with production scale up of new and old processes.

4. Implements scale up of new processes and potential scale up for current processes.

5. Identification and implementation of new technology. Reads scientific and trade journals, communicates

with suppliers and sources of new technology, attends seminars, webinars, and other presentations to

identify new methods, equipment, and technologies.

6. Assists other employees as necessary. Examples include protein purification and analysis, calibration and

preventive maintenance of equipment and facility, and filling of orders.

7. Assures that all work is properly recorded and signed off in lab notebooks, batch records, worksheets, or

other appropriate documents.

Other Duties

1. Complies with all safety protocols

2. Performs other assigned duties

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 function.

Education/Experience

B.A. in a related field from an accredited college or university plus at least five years’ experience or master’s degree with three years’ experience, or equivalent combination of education and experience.

Physical Demands

The physical demands described here are representative of those that must be met by and 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.

JD 47 Rev 3 Status: RELEASED printed 6/22/2026 8:52:52 PM by Gina Stokes

Effective Date: 02-27-2023 Page 2 of 2 Confidential

While performing the duties of this job, the employee is frequently required to stand, walk, use hands, reach with hands and arms and talk and hear. The employee is occasionally required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.

The employee may be required to wear personal protective equipment such as gloves, a lab coat, safety glasses or goggles, a face shield, a respirator or other equipment necessary for safe performance of the job requirements. The employee may be required to wear gloves, gowns, hairnets and other clothing in order to protect product integrity.

Training Required

ISO Regulations, QSR (cGMP) Regulations New Employee Orientation

Blood-borne Pathogens Regulation, HIPAA Regulations QAPs, SSOPs and SOPs

Relevant equipment, methods and batch records Note: Additional training provided as needed.

Reasoning Ability

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Communication

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.

Math Ability

Ability to calculate figures and amounts such as discounts, interest, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Able to use routine chemistry formulas.

Equipment Used

Balances, Centrifuges, Chromatography columns, pumps, fraction collectors, and monitors

Clinical chemistry analyzer, Filtration and ultra-filtration equipment Gel electrophoresis and blotting equipment, Laminar flow hood, Lyophilizers, Mixers Multiwell plate reader, Personalcomputer, pH and conductivity meters, Pipettes Tissue homogenizers, grinders, and blenders, UV-VIS spectrophotometers and other equipment as needed or directed

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.

While performing the duties of this job, the employee is frequently exposed to wet or humid conditions (nonweather); work near moving mechanical parts; fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to work in high, precarious places; outdoor weather conditions; extreme cold (non-weather); extreme heat (non-weather); risk of electrical shock and vibration. The noise level in the work environment is moderate.