Associate Scientist, Analytical Development

Company: Horizon Therapeutics
Location: San Mateo
Posted on: May 8, 2022

Job Description:

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

Position Summary:

The Associate Scientist/Analytical Specialist, Analytical Development position reports to the Director Analytical Development. This position is responsible for testing, developing and validating analytical methods for development products for small and large molecules, troubleshooting analytical methods for the existing commercial products with minimum supervision.

The incumbent is responsible for, writing and reviewing analytical method validation protocols, validation reports, and review raw data/protocols/reports for early phase to phase III development projects.

This position will provide analytical support to Senior Scientists working in, Formulation Development, Nonclinical Development, Process Development, Manufacturing, Quality Assurance and Quality Control groups for both small and large molecules and support of new product development to meet Corporate Goals and Objectives. This position will actively involve in the analytical method development, method transfers and troubleshooting analytical and technical issues on the development and commercial products with minimum supervision. Additionally, the person must be able to work with outsourced CMC contractors to develop analytical methods, stability protocols and manage the testing and release of clinical materials that meet GMP requirements. Hands on experience with HPLC, GC, Dissolution apparatus, and experience in large molecule testing is an asset.

Responsibilities:

Associate Scientist Level Responsibilities:
Testing Pharmaceutical products following compendial methods Developing and Validating Analytical methods IQ/OQ/PQ and Annual Calibration of Lab Instruments using an in-house protocol Conducting Shipping Studies (in house) for both small and Large Molecules Handling Lab Purchase Activities Provide support to analytical development activities, such as method development, qualification and testing, at CMO and CRO sites to ensure outsourced studies are executed successfully and meet the objectives Provides Analytical support for release and stability testing of drug substance, raw materials, intermediates, and drug product Identifies analytical science capabilities and technology tools needed to enable manufacturing process development, QC testing, and new drug formulation development. Applies scientifically driven thinking to the development of scientifically sound, well understood, and robust analytical methods Coordinates with other internal departments to write qualification/validation of analytical methods, stability protocols and reports Handles analytical method transfer Review of raw data packages associated with release testing, stability testing, and other characterization testing of drug substances and drug products Prepares and delivers technical reports, documents, batch analyses, analytical methods, reference standard, etc Set up and perform experiments in the laboratory in support of pre-formulation, analytical method development, manufacturing process development, and troubleshooting Hands on experience with HPLC, GC, Dissolution apparatus, and experience with analytical instrument used for testing large molecule is an added advantage for this position Utilize in-house capabilities to develop and troubleshoot analytical methods

Qualifications and Skills Required:
B.S., in chemistry or other scientific discipline. 3- 5 years of working experience in the pharmaceutical Analytical Development /QC Laboratories Experience in analytical method development/validation is required Experience in Trouble shooting analytical method related issues Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents (ICH and FDA) as they relate to quality testing of pharmaceutical products Ability to establish and maintain effective working relationships Ability to learn the potential of new technologies to meet analytical testing requirements Detail-oriented, with good organizational and project management skills. Ability to effectively prioritize and deliver on tight timelines Good oral and written communications skills; proficient with MS Word, PowerPoint, and Excel Generates shelf life projections for the drug substances and drug products using statistical methods and analyzes data for any trends Up to 20% travel may be required Bench work expected for this position is about 90%

Horizon Core Values & Competencies:

Growth
Manages Ambiguity Strategic Mindset Demonstrates Self-awareness Cultivates Innovation Develops Talent

Accountability
Drives Results Ensures Accountability Decision Quality

Transparency
Courage Collaboration Instills Trust

Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). "Fully vaccinated" is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law.

Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

Keywords: Horizon Therapeutics, San Mateo , Associate Scientist, Analytical Development, Other , San Mateo, California