Formulations Scientist - Solid Oral Dosage Pharmaceuticals
Adare is seeking a PhD Formulations Scientist to join our innovative R&D team in Dayton, OH.
The Formulations Scientist will develop pharmaceutical dosage forms with the main emphasis on modified-release and orally disintegrating solid oral dosage forms.
The primary duties and responsibilities of this position include the following:
- Design and perform formulation development studies on controlled release and bioenhanced oral solid dosage forms (tablets and capsules) defined by management/customer and assume the responsibility needed to meet the product specific objectives.
- Develop new products utilizing existing and new technologies available within the industry from pre-formulation to manufacturing stage.
- Develop and/or locate new technologies that will be of interest to the Company's product development objectives.
- Assist both Manufacturing and Quality Assurance departments in scale-up and production problems.
- If desired, perform technology transfer to customer production sites and train/assist customer personnel in scale-up and production.
- Comply with all regulations as specified by OSHA, EPA, FDA, DEA, etc., and as defined in the Corporate Hygiene plan.
- Assist in writing and preparation of Drug Master File reports and any other FDA required documentation.
- Supervise/train formulation scientists and ensure their activities comply with CGMP regulations.
- Maintain excellent oral and written communication with and ensure customers' requirements are promptly met.
- Completes assigned tasks in a safe manner and in a constant state of alertness.
- Upholds all Company policies, including but not limited to, the Adare Code of Conduct and the Professional Conduct Policy and Prohibition Against Harassment Policy.
- Supports the Adare vision and mission and exemplifies Adare values.
- Follow other job-related instructions and perform other job-related tasks as required.
- Ph.D. degree in Pharmacy or Chemical Engineering or related physical sciences with 0-3 years experience
- Knowledge of pharmaceutical operations, including tableting, particle coating for controlled or targeted release applications, encapsulation, Lyophilization, fluid bed operation, and microencapsulation.
- Knowledge of CGMP's, FDA, DEA, and OSHA regulations.
- Knowledge of PK-PD relationships and IV/IV correlation's desirable.
- Good oral communication and technical report writing skills.
COMPETENCIES & ATTRIBUTES
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.
- Excellent interpersonal written and oral communication skills
- Interface with Manufacturing, R&D, Quality Control, management personnel, customers, outside vendors, and suppliers.
- Work with minimal supervision and reviews controversial issues or questions with manager.
- Conducts and manage development projects with manager's guidance and ensure the successful scale-up of a new product and/or process.
- Confidentiality of projects, test results, personnel matters and both customer and Company information/data is a definite requirement.
Adare Pharmaceuticals, Inc. is an Equal Opportunity Employer - M/F/V/D
Adare is a global specialty pharmaceutical company inspired to improve the lives of patients whose treatment needs are not fully addressed by current medications. We use our unique combination of experience, proprietary capabilities, and resources to create meaningful products for them.
Our entrepreneurial and performance driven culture encourages us to take risks, identify promising ideas, and see those opportunities through to completion. Our collaborative spirit and dedication to developing strong partnerships provide Adare and our partners with significant advantages in competitive markets.
Adare is a high-growth company with a long history of success from concept through commercialization. Our ability to create differentiated drugs guides the identification and development of the novel products in our pipeline and our acquisition strategy.
Thu, 10 Aug 2017 07:57:54 PDT