Associate Scientist to Sr. Scientist, Product DevelopmentBack to Jobs
Execute formulation development work to support new products, develop drug products to support clinical development programs.
- Understand and independently perform high-quality, hands-on experimental design of formulation development
- Review, compile and document data and results and compares them to acceptance criteria, SOP requirements, methodologies, product specifications, etc.
- Assist in the preparation of scientific reports,
- Develop and write experimental protocols
- Comply with SOP’s and cGMP practices in documentation and equipment operation
- Create formulated product for research, biological, and tox studies
- Prepare formulation and technology transfer reports, participate in process transfer to Manufacturing and other CMOs for fill-finish of drug product.
- Develop methods to support formulation and process activities and participate in setting detailed specifications as needed. Oversee detailed technical requirements, resource requirements, timelines and decision points in a manner consistent with the Company’s mission and priorities.
- Interact closely with counterparts in Research, Project Management and Finance, and participate in regular project and CMC review meetings to ensure effective communication and sharing of information.
- May perform other related duties as required and/or assigned, including providing advice and technical support to the broader Operations department.
Nature and Scope:
Interacts with various levels of personnel internally, and typically a similar level externally requiring the ability to clearly understand and communicate policies and procedures. Requires a solid working knowledge relevant to the applicable field. Job encounters problems of limited scope and moderate complexity with occasional variations from the norm. The incumbent receives instruction on new assignments and limited instruction on routine work. Errors in work could cause delays and financial loss.
BS degree in Analytical Chemistry, Pharmaceutical Sciences or a related discipline, or an equivalent level of knowledge and experience.
- 3-7 years’ experience in formulation development
- Proven record of success preparing pre-clinical compounds, and performing stability and compatibility studies
- Excellent technical writing skills
- In-depth scientific knowledge and hands-on experience in formulation development
- Knowledge of GMPs and regulatory requirements as related to product development
- Experience in analytical method development and validation is highly desirable
Works in an office and laboratory environment. May on a continuous basis walk, bend and lift up to 20 lbs. The noise level in the work environment is usually moderate to high. May intermittently sit at desk for a long period of time to answer telephone and write or use a keyboard to communicate through written means. Must be flexible to work varying schedules and hours as needed. Occasional travel may be required. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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