Scientist II, Bioanalytical

Company: Horizon Therapeutics
Location: Silver Spring
Posted on: June 24, 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.

Responsibilities:
Designs, executes, and interprets results of bioanalytical assays
Where necessary, develop solutions to and overcome issues with established methods
Prepare method procedures, qualification, and bioanalytical study reports
Assist with transfer of PK, ADA, and nAb assays to CROs for qualification/validation in a GxP environment
Involved in planning experimental design and execution of all aspects of preclinical and clinical bioanalysis including, de novo assay development, optimization, and troubleshooting of in vitro and cell-based assays
Current with industry thinking on bioanalytical approaches; and where possible present data at scientific conferences
Supports efforts to generate and interpret data and communicate results internally and externally
Builds strong relationships and networks externally as well as internally with therapeutic area leaders, facilitating strategic alignment and collaborations with partners
Maintains accurate and complete safety records consistent with company policy and legal requirements. Recognizes potential safety problems and takes action to rectify them



Qualifications and Skills Required:
MS or PhD in relevant life science discipline
8+ (MS) or 2+ (PhD) years in the biopharmaceutical industry, preferably in large molecule drug development
3+ years managing CROs
In depth experience in ligand binding assay development (e.g. ELISA, ECL/MSD)
Knowledge of assay development and validation, and understanding GXP requirements and ICH/regulatory guidance to support the regulatory approval process
Leadership experience in both project and people management
Authoring reports/presentations/communication bullet
Experience within a fast pace biotech environment
Proficient in Microsoft Office
Professional demeanor
Self-starter attitude
Strong interpersonal skills
Excellent written and verbal communication skills



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, Silver Spring , Scientist II, Bioanalytical, Other , Silver Spring, Maryland