What are the responsibilities and job description for the Lead Scientist, Large Molecule Bioanalysis IN OFFICE AUSTIN, TX position at Worldwide Clinical Trials - USA?
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us!
What the Lead Scientist, Large Molecule Bioanalysis does at Worldwide
The lead scientist is responsible for designing, developing, and validating ligand binding assays and overseeing clinical sample analysis for immunogenicity and pharmacokinetic (PK) testing of biologics. This position is for a full-time and onsite opportunity at the Worldwide Bioanalytical lab in Austin, TX.
What you will do
What you will bring to the role
Your experience
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide !For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative,innovative,and successful. We’reon a mission to hire thevery bestand are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us!
What the Lead Scientist, Large Molecule Bioanalysis does at Worldwide
The lead scientist is responsible for designing, developing, and validating ligand binding assays and overseeing clinical sample analysis for immunogenicity and pharmacokinetic (PK) testing of biologics. This position is for a full-time and onsite opportunity at the Worldwide Bioanalytical lab in Austin, TX.
What you will do
- Design and develop PK, Immunogenicity assays for large molecule therapeutics.
- Implement FDA, EMA and ICH recommendations and guidelines for biological assays.
- Troubleshoots ADA and nAb for mAb, bi-specific Abs, ADC, and fusion proteins
- Review and approve bioanalytical validation and study reports
- Review clinical protocols to and RFPs to determine assay requirements for sponsors.
- Ensure study design, sample collection adequately supports ADA and NAb testing requirements.
What you will bring to the role
- Thorough understanding of GLP, GCLP and FDA recommendations/guidelines for PK and immunogenicity assays for biologics.
- Well versed with the MSD and ELISA platforms for application in LBA.
- Writing research white papers, abstracts, research articles
Your experience
- Ph.D in immunology or related biomedical research fields.
- Minimum of 3 years of post-Ph.D. work experience in research involving immunological assays for antibody and/or protein therapeutics.
- Experience in developing, validating, and implementing ligand-binding assays (LBA) for PK, ADA and NAb assays for and antibody and protein therapeutics.
- Experience writing and/or reviewing bioanalytical assay validation plan and study reports.
- Experience in training and managing laboratory personnel.
- Experience interfacing with biopharma clients and working in a collaborative work environment across cross functional teams.
- Experience in data interpretation of ADA and NAb assay results.
- Experience in flow cytometry assays for cell phenotyping and cell-based assays for nAb testing.
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide !For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative,innovative,and successful. We’reon a mission to hire thevery bestand are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
