R&d Chemist

1 month ago


Lompoc, United States DenMat Holdings, LLC Full time

**Objective**
- To lead the benchtop efforts in both the development of new dental materials and the improvement of existing Company products through exploration, formulation, and testing. The R&D Chemist provides support to the Director, Product Development Materials and provides sustaining engineering support to resolve current or potential product or process issues. The R&D Chemist will work within the guidelines of a phase / gate Product Development System and in accordance with applicable medical device regulations worldwide and will work according to appropriate laboratory standards.

**Essential Duties and Responsibilities **include the following. Other duties may be assigned.
- Perform chemical analysis and physical testing for new product development and existing products.
- Perform testing and selection of new raw materials.
- Participate in the Design Control process for new products and product enhancements.
- Work closely together with Compounding Department for Design Transfer activities.
- Perform aging tests for new product development and existing products.
- Generate new ideas and products for both professional and consumer market.
- Understand and improve existing products, processes, technologies, and services.
- Conduct research activities on initiated or assigned projects.
- Properly document all development activities and provide required documents as outlined in the Company’s Product Development System.
- Provide support as needed for Regulatory and Quality activities such as internal and external audits, complaint investigation/processing, process validation, and quality control specification development.

**Additional Duties and Responsibilities **include the following. Other duties may be assigned.
- 1. Assist in the establishment and maintenance of departmental goals, projects and performance measurements.
- 2. Coordinate technician activities to promote completion of projects.
- 3. Initiate or suggest plans to archive departmental and/or work process goals.
- 4. Other projects as assigned.

**Supervisory Responsibilities**
- This job has no direct supervisory responsibilities but may offer advice and counsel to the supervisor/manager regarding the performance and progress of the technical staff below this grade assigned to given projects.

**Education and/or Experience**
- BS degree in Chemistry or Chemical Engineering with Polymer Science/Engineering experience required. Three to five years of analytical experience in the medical device industry preferred; or equivalent combination of training and experience. Advanced degree with experience in Dental Materials desired but not required.

**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, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the described functions.

**Language Skills**
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical journals and procedures and governmental regulations. Ability to write reports, business correspondence, documentation and procedures. Ability to effectively present information and respond to questions from groups of managers or technical peer groups.

**Mathematical Skills**

**Computer Skills**

**Certificates, Licenses, Registrations**
- None required.

**Desired Knowledge, Skills and Abilities**
- Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), and 21 CFR Part 11 (Electronic Records; Electronic Signatures). ISO 9001:1994, ISO 13485:1996, ISO 13485:2003, Council Directive 93/42/EEC June 1993 (Medical Device Directive), and the Canadian Medical Device Regulations, 1998 (as applicable).
- Knowledge of regulatory requirements that relate to process design.
- Knowledge of medical device, or drug manufacturing.
- Ability to demonstrate leadership in job performance by example.
- Ability to function and be recognized as a technical expert and internal consultant to Allergan Medical.
- Knowledge and experience with analytical tools such as IR Spectroscopy and Gas Chromatography.
- Ability to guide and delegate to subordinates.
- Ability to provide objective input to management regarding the performance of technician staff members below this grade who are assigned to projects under the direction of this position.
- Ability to present facts and recommendations effectively in both oral and written form.
- Ability to interface with many levels of employees of various disciplines within various departments.
- Ability to maintain accuracy, consistency and quality of documentation and projects while managing assignments in a fast-paced, multi-task environment.
- Ability to function in a controlled environment under domestic and international regulations and handle extremely confidential data.
- Ability to take initiative and