Sr Scientist, Analytical Sciences
Company: Horizon Therapeutics
Location: Silver Spring
Posted on: June 19, 2022
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.
The Senior Scientist, Analytical Sciences is responsible for
protein therapeutics development, qualification and transfer of
methods that demonstrate the safety, purity and potency of
molecules across the entire portfolio and through all stages of
clinical development via release, characterization and stability
- Serve as the subject matter expert for molecule developability,
product characterization, CQA assessment, method issues, including
experiment design, data interpretation, and troubleshooting.
Contribute to the investigation and resolution of
out-of-specification (OOS) and out-of-trend (OOT) testing
- Responsible for physical chemical method development,
optimization, qualification, and transfer to CDMO and QC (Quality
Control) laboratories for release testing clinical and commercial
- Review characterization plan/reports, comparability
protocol/reports, method SOPs, method
development/transfer/qualification and validation protocols and
- Preparation and review of CMC sections related to analytical
procedures, method validation, comparability, specifications,
reference standard and stability in INDs, IMPDs, MAAs, BLAs, and
other regulatory submissions.
- Support process development including upstream (cell line, cell
bank, cell culture development), downstream (impurities analysis,
in process testing), formulation group (formulation screening,
compatibility) and later stage process characterizations. Support
research group's molecules generations, validation, and potential
new molecule nomination for clinical study.
- Collaborate with QA to establish guidance and procedures.
Support analytical laboratory harmonization across different sites
and analytical method transfer internally. Support new laboratory
capabilities establishment with purchase of new equipment and
- BS. MS or PhD in Chemistry, Biology, Pharmaceutical Sciences or
Life Sciences and related experience (BS 10 years, MS 8 years, PhD
- Significant in-depth technical expertise in analytical
development and commercialization of biologics. Broad knowledge of
protein chemistry and structural characterization of mAbs and novel
biologics using biochemical and biological techniques.
- Proven experience with late stage characterization, CQA
assessment, control strategy, and marketing applications
- Demonstrated expertise in methods including
chromatography-based method (HIC, IEX, SEC), electrophoresis-based
methods (cIEF, CE-SDS), mass spectrometry-based methods (peptide
mapping, host cell protein analysis), and other excipients analysis
such PS80, PS20, and Poloxamer 188.
- Familiar with USP and EP guidelines, including appearance,
particles, bioburden, endotoxin, sterility. Familiar with
regulatory guidelines from ICH, FDA and EMA.
- Experience in cGMP and QC practices including reference
standard, stability, and validation. Experience in the successful
transfer of methods to Quality functions within, and external to,
- Have the ability to effectively prioritize and manage a
diversified workload, often to strict deadlines. You should have
strong interpersonal skills, a professional approach with excellent
w r i tten a nd v erbal c omm uni c ation s ki l ls.
- Highly flexible as this is an agile, growing organization that
needs to adapt quickly to new acquisitions and market demands.
- Demonstrated technical proficiency, scientific creativity and
innovation individually and in collaboration with others.
Horizon Core Values & Competencies:
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent
- Drives Results
- Ensures Accountability
- Decision Quality
- 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 , Sr Scientist, Analytical Sciences, Other , Silver Spring, Maryland
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