Senior Analytical Scientist - Pharmaceutical Operations
Primary roles include provide leadership in analytical development, validation, API and Drug Product Stability testing and writing CMC sections of the IND, NDA and ANDA submissions. Incumbents have responsibility for research experiments and data integrity, as assigned by management. Incumbents must be able to design and implement an experiment based on an overall description of the intended outcome. Incumbents will also serve as a mentor to Analytical Scientists.
Reports to the Director, Pharmaceutical Research. Internal relationships include Formulation Scientists.
•Work closely with formulators to support formulation development
Primary role in method development and formulation development support
• Conduct literature search and develop robust analytical methods for new products
• Write protocols and report for method development and validations that are ready for submission to regulatory authorities.
• Provide support in project management with contract manufacturing and testing facilities.
• Provide analytical testing support for new (primarily inhalation products, but also other solid and liquids) dosage forms
• Help develop test specifications for new products
• Ensure data integrity, conduct data collection and interpretation and ensure proper documentation of experimental data. Maintain laboratory notebooks.
• Complete assignments requiring an expert level knowledge of techniques and practices related to the analytical area.
• Expertise in GMP laboratory requirements and compliance in accordance with relevant regulations.
• Manage site inventory. Order laboratory supplies and equipment. Maintain the laboratories and perform other job related duties as assigned.
• Accumulate knowledge and skills to support development and management of research protocols in support of multiple drug discovery efforts.
• Achieve business goals, share learning's, knowledge and skills and promote cross-functional teamwork.
• Use knowledge and experiences to interpret and properly document experimental data.
• Other work as assigned based on the project and company needs.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
• A BS in Chemistry or related field with 5 years of relevant experience from the pharmaceutical industry required.
• Prior experience in handling analytical instrumentation such as HPLC, GC, UV/VIS in a GMP environment.
• Knowledge of ICH and FDA guidelines
• Prior Chromatographic Data Acquisition and LIMS Systems experience.
• A high degree of computer proficiency and the ability/interest to learn new software programs required.
• Excellent skills in collecting data and accurately maintaining laboratory notebooks required.
• Expert level technical skills.
• Flexibility and the ability to work in a fast-paced, team-oriented environment.
- Prior experience with inhalation product development preferred.
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Additionally, this job description reflects management's assignment of essential functions. It does not prescribe or restrict the tasks that may be assigned.
Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients. Using proprietary sublingual spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intending to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS currently markets one product, SUBSYS.
Sat, 26 Aug 2017 17:25:39 PDT