Address
Form of workJob Description
Job Description
Date
01/2024Location
1200 Airport Road, North Brunswick NJ
Title
Chemist Regulatory
Department
Research & Development
Reports to
Director, Research & Development
FLSA (Exempt or Non-Exempt
Exempt
Areas of Responsibility
- Strategic sourcing and planning, vendor identification and qualification, negotiations, business, and supply agreements.
- Preparing and managing long-term and short-term production schedules to ensure on-time delivery of products and target inventory levels.
- Monitoring SKU levels and recommending future SKU rationalization. Review literature for new project concepts, feasibility of formulations and collect evidence for the safety and efficacy of products.
- Develop technical marketing presentations for new product proposals.
- Work with the purchasing team to generate new formulations, source raw materials for cost analysis, and feasibility of formulations.
- Maintain accurate project information, formulation, and product specifications.
- Collaborate with QA in the development of proper documentation for new products.
- Coordinate with offices in India and China on a regular basis for product development, documentation, and quality testing for each product.
- Coordinate with internal departments- QA, QC, and Supply Chain to ensure documents are aligned.
- Keeping track of potential regulatory compliance issues with business impact.
- Following changing regulatory requirements relevant to compliance.
- Troubleshoot technical, formulation, and processing issues during product development and commercialization.
Safety Requirements:
- Works in a safe and responsible manner to create an injury-free and incident-free workplace.
- Complies with all job-related safety and other training requirements.
- Keeps management informed of area activities and of any significant problems.
Requirements
Education & Qualification:
MS in Chemistry, Chemical Engineering, Pharmacy, or related field with 2 years’ experience.
Certifications, Licenses, Credentials:
- N/A
Skills & Ability
- Strong comprehensive written and verbal communication skills
- Proficient in a subset of basic tools: Excel, Word, PowerPoint
- Ability to work independently or collaboratively.
- Must be able to lead projects that require cross-functional collaboration
- Must have the ability to learn quickly, and excel in a fast-paced environment
- Must have attention to detail.
Physical Requirements (lifting, etc.):
- Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds.
- Must stand and walk on the production floor for a minimum of 6 hours per shift
- Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances.
- Occasionally works from a rolling ladder or step stool, must lean over equipment as well as kneeling on the floor to clean under the equipment.
- Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.
Work Environment (Office, Warehouse, temperature extremes, etc.):
- Work is regularly performed inside a manufacturing environment where temperatures can be moderate, and exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
