Principal Scientist – Small Molecule Analytical Sciences - Irvine, CA

Organization
Allergan
Job Location
Irvine, CA
Job Description

Allergan is hiring for a Principal Scientist - Small Molecule Analytical Sciences position, to be located in Irvine, CA. 
In early 2015, Actavis completed the acquisition of Allergan. This combination united two growing, successful and profitable companies into a unique, global pharmaceutical company and a leader in a new industry model - Growth Pharma. In June 2015, the combined company changed its corporate name to Allergan plc and its stock ticker to NYSE:AGN. 
Today, our nearly 30,000 talented global employees are creating an unrivaled foundation for long-term growth. We combine highly regarded brands and a best-in-class generics business with an enviable pipeline and lean, reliable operations to drive value for customers. 
Join one of the world's fastest growing specialty pharmaceutical companies! 
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn't just welcomed, it's encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of stretch assignments and opportunities to step into the spotlight. 
Position Description 
The Principal Scientist - Small Molecule Analytical Sciences will be an instrumental contributor and will be functionally aligned to Small Molecule Product Development. Using advanced analytical technologies, the Principal Scientist - Small Molecule Analytical Sciences will design, manage, lead, and implement analytical development activities in a cGMP environment to support all stages of drug development including drug substance and drug product development. This incumbent will develop novel methods to solve challenging analytical problems. This individual will validate and transfer analytical methods. 
The Principal Scientist - Small Molecule Analytical Sciences will independently manage multiple projects and ensure timely delivery of all deliverables. S/he will establish, direct, coordinate and monitor activities at contract labs to ensure quality and timeliness of work. S/he will generate, review and approve analytical data, technical reports and analytical methods for inclusion in relevant sections of clinical trial applications and applications for marketing authorization; S/he will author relevant sections of regulatory submissions as required. S/he will evaluate, recommend, purchase and install new equipment to meet project needs. S/he will collaborate with cross-functional groups to meet drug development milestones. The Principal Scientist - Small Molecule Analytical Sciences will contribute to CMC teams and make oral presentations at project meetings. This individual will introduce cutting-edge technology to enhance the capability of the department. This incumbent will publish and give presentations at both internal and external meetings. S/he will supervise, mentor and direct the work of junior professional staff, as assigned. The successful candidate should have thorough knowledge of analytical R&D functional roles and responsibilities and basic knowledge of the drug development process. The Principal Scientist - Small Molecule Analytical Sciences will proactively contribute to drug development teams for strategies and problem solving. The successful candidate should have knowledge of relevant regulatory requirements and guidelines. Experience in cGMP is essential as is expertise in various analytical instrumentations (e.g., HPLC, GC, LC-MS, GC-MS, NMR). 

Requirements: 

Qualifications 
A PhD (or equivalent experience) in Analytical Chemistry or Organic Chemistry and 6 years of pharmaceutical industry experience in the development and validation of analytical methods to support drug development and product registrations is required. Proven ability to apply advanced chemical analysis principles, theories, and concepts to solving complex problems associated with drug development is required. Strong ability to evaluate and interpret analytical results (including stability data) leading to recommendations regarding product quality required. Knowledge of and familiarity with cGMP and regulatory requirements (FDA and international) is required. Experience in authoring relevant CMC sections of regulatory filings is preferred. Excellent written and oral communications as well as project management skills required. This position is located in Irvine, CA and may require minimal travel.

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