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Senior Formulation Scientist
Job ID: 2021-2199
Type: Regular Full-Time
# of Openings: 1
Category: Research - Dept
We are hiring Scientists for our R&D team with unique skills and experience who are committed to advancing product innovation by applying emerging technologies, sound science, and vigorous design and development processes. This position is based in our new research lab located in Phoenix, AZ.
We are seeking an experienced formulation scientist to join our expanding R&D team at our Phoenix location. The candidate will be responsible for the development and evaluation of new formulations and/or formulation platforms of complex pharmaceutical products such as SEDDS, nanoemulsions, nanoparticles, controlled release tablets/capsules etc. The ability to work effectively in a collaborative, interdepartmental team environment is essential to this role. A thorough understanding of pharmaceutical development process from discovery to commercialization is highly desirable. As a member of the R&D team, you will play a pivotal role in discovering and developing breakthrough medicines and novel technologies that can change peoples lives.
- Perform extensive literature and patent searches to provide background basis for development plans
- Lead efforts on new product candidate selection, technology development and patent filings/prosecution
- Conduct pre-formulation studies including drug characterization, solubility determination, excipient compatibility assessment
- Design formulations and process for complex and challenging compounds
- Conduct routine testing for formulation development, in-process and informal stability testing
- Work closely with analytical scientists in analytical method development and drug product stability assessment
- Keep current with regulatory guidelines, technical innovations, and new developments within pharmaceutical industry
- Responsible for working and monitoring with external contract labs and reviewing technical reports
- Participate in selection and management of vendors for provision of clinical trial supplies (CTS) manufacturing, packaging, labeling and distribution activities
- Responsible for product/process transfer to partners & contract manufacturers, process scale-up activities, and clinical supplies manufacture
- Write and review CMC reports and documentation for regulatory filings
- Effectively communicate with cross functional teams like clinical development, quality control, quality assurance, compliance and regulatory affairs
- Attend SOP, safety and scientific trainings to remain current with cGMP regulations, and safety standards
- Follow relevant Radius SOPs and FDA/ICH guidance
- Other duties as assigned
- PhD in Pharmaceutics, Chemistry, or Chemical Engineering
- Interest in working in Phoenix, AZ
- 0-2+ years relevant working experience in Pharmaceutical/Biotechnology industry
- Experience in innovative approaches to solving formulation challenges and formulation technologies to improve solubility and bioavailability of poorly water-soluble compounds
- Knowledge in pharmaceutical product development and CMC regulatory requirements
- Fundamental understanding of GMP, ICH and FDA compliance
- Excellent written and oral communication and interpersonal skill
The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Travel may be required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.
Equal Opportunity Employer Statement:
Radius Health, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Radius Health, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation, and training.