Scientist II, Bioanalytical
Company: Horizon Therapeutics
Location: Silver Spring
Posted on: June 24, 2022
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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
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