Senior Formulations Scientist - Solid Oral Dosage Pharmaceuticals
The Sr Scientist formulations pharmaceutical dosage forms, with the main emphasis on modified-release and orally disintegrating solid oral dosage forms. The Sr Scientist will also lead, direct, and prioritize projects assigned to this position and associated formulation staff.
The primary duties and responsibilities of this position include the following.
- Serve as a technical representative and the lead formulation scientist on cross-functional project teams.
- Design and execute experiments to support the development of solid oral dosage forms, Develop new products from lab-scale through scale-up, utilizing existing and new technologies
- Develop and identify new technologies that will enhance Company's product development objectives Assist Manufacturing and Quality Assurance departments in scale-up and production problems.
- 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 preparing Drug Master Files and other regulatory documents in support of product development and approval.
- Supervise/train junior formulation scientists and technicians and ensure their activities comply with company, departmental and cGMP regulations.
- Maintain excellent oral and written communication with customers, and ensure customers' requirements are promptly met.
- Attends work on a regular and predictable basis.
- Completes assigned tasks in a safe manner and in a constant state of alertness.
- Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.
- Works in a cooperative manner with managers, supervisors, coworkers, customers and the public.
- Works effectively under deadlines.
- Perform other job-related tasks, as required.
- Pharmaceutical Sciences, Chemical Engineering, Physical-Organic Chemistry, or related field with a minimum experience of 6-8 years (Bachelor's degree) yrs, 4-6 years (Master's Degree) and 3-5 years (Ph.D.)
- Strong background in pharmaceutics, bio-pharmaceutics, modeling and simulation, solid dosage formulation development, Novel drug delivery technology, and processing technologies in order to be able to invent, innovate and implement new ideas.
- Broad knowledge and extensive experience in drug product development projects in various phases to facilitate efficient and successful implementation of projects.
COMPETENCIES & ATTRIBUTES
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.
- Pharmaceutical operations including; blending, compression, particle and tablet coating for controlled or targeted release applications, capsule filling, roller compaction, extrusion/spheronization, fluid bed operation, microencapsulation and packaging.
- Knowledge of cGMP, FDA, DEA, and OSHA regulations.
- Knowledge of PK-PD relationships and IV/IV correlations desirable.
- Strong knowledge and experience with chemistry of degradation and chemical kinetics.
- Knowledge of instrumental methods of analysis.
- Good oral communication and technical report writing skills.
- Excellent interpersonal skills.
- Ability to interface with Manufacturing, R&D, Quality Control, Quality Assurance, Regulatory Affairs, management personnel, customers, outside vendors, and suppliers.
- Ability to work with minimal supervision
- Possesses good judgment and reviews controversial issues or questions with manager.
- Computer literate.
COMPANY POSITION STATEMENT
This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position. While this is intended to be an accurate reflection of the current job, Adare reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).
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 07:55:40 PDT