Senior Scientist- Biologics
1 month ago
Senior Scientist - Biologics
Full Time
Exton PA
Frontage Laboratories
Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals. We have enabled many innovator, generic and consumer health companies of all sizes to file IND, NDA, ANDA, BLA and 505(b)(2) submissions in global markets allowing for successful development of important therapies and products for patients. We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance. We have successfully assisted clients to advance hundreds of molecules through development to commercial launch in global markets. Come and join us to make a world of difference.
Biologics
Frontage's biologics teams have an average 10 - 15 years in complex drug development and have worked with large molecule applications throughout its evolution in product development. We can handle projects for a range of large molecule development projects including peptides, proteins, monoclonal antibodies, bispecific antibodies, biosimilars, oligonucleotides, biomarkers, and antibody drug conjugates.
Gain access to comprehensive biologics services in support of advanced development programs with Frontage's bioanalytical laboratory. We have the capabilities to analyze virtually any peptide, protein or antibody, and have built a reputation for solving technical challenges related to assay development and validation.
Position Summary
Test transferred methods or develop bio-analytical methods for the assessment of pharmacokinetics, pharmacodynamics, and immunogenicity of bio-pharmaceutical compounds in biological matrices by use of ligand binding based assay applied to a variety of technology platforms including but not limited to ELISA, Gyros, Simoa, Luminex, Mesoscale Discovery, and Flowcytometry, Real-time PCR, ddPCR, and NGS in a manner consistent with current regulatory expectations for bioanalysis. A method development staff scientist supports multi-disciplined studies, generates results, solve problems, communicates with clients and internal stakeholders and interprets data of a scientific nature.
Responsibilities
* Skillfully perform a variety of analytical ligand binding techniques and methodologies, such as ELISA, ECL, and cell-based assays.
* Highly motivated to learn and use new techniques and instrumentation to improve bioanalytical operations.
* Capable of playing a leadership role in troubleshooting to solve challengeable bioanalytical problems.
* Independently develop analytical methods for validation assays to meet expected requirements of sponsor's timeline, scientific quality and compliance of regulatory agencies
* Effectively apply scientific theories, concepts and techniques to development of new approaches to meet regulatory requirements in bioanalytical and ligand binding studies.
* Proactively respond to unscheduled deadlines, client needs, and request ad hoc etc. without neglecting other duties.
* Take accountability to set up, maintain, operate and perform routine and non-routine maintenance on general equipment, including problem identification and resolution.
* Know well how to monitor, evaluate, and review the scientific performance of assays.
* Timely interact with internal/external clients, as needed.
Requirements
* Ph.D. in pharmacology, molecular biology, biochemistry, immunology, or related fields with 1-2+ years' experience, or Master's degree in same disciplines with 4+ years' experience, or Bachelor's degree in same discipline with 6+ year experience.
* Experience or knowledge of analytical instrumentation (e.g., plate readers, Mesoscale Discovery(MSD), Gyros, Simoa, Luminex, and Flowcytometry, Realtime PCR, ddPCR, and NGS.
* Demonstrate experience or training in laboratory automation software, system software, and Microsoft office applications
* Experienced in performing scientific presentation.
* Strong oral and written communication skills.
Significant Safety or Working Considerations:
May work with potentially infectious samples of human and/or animal origin May handle hazardous chemicals
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability
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