Bioanalytical Program Lead

LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.

We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.

Summary

The Bioanalytical Program Lead, as part of the client's Integrated Bioanalysis (IBA) Global Team, will lead the design and implementation of robust bioanalytical strategies. This role will ensure lab-based activities are aligned with context of use, working closely with other scientific and technical lab staff in a matrix environment to manage aspects such as experimental design and tech transfer in regulated bioanalysis supporting therapeutic modalities across a range of therapeutic areas.

Required Knowledge and Skills

• Experienced as a bioanalytical lead in diverse project teams, defining, leading and implementing robust bioanalytical strategy to advance the portfolio.
• Skilled scientist able to discern the advantages and pitfalls of a range of analytical techniques with a deep understanding of small molecule Bioanalysis and Mass Spectrometry.
• Knowledge of analytical chemistry, Immunology and or metabolic diseases is preferred.
• Effective oral and written communication skills in English, experienced with technical writing. Proven publication and presentation record.
• Exceptional verbal and written communication skills.
• High level of attention to detail is required.
• Ability to work effectively in a matrix environment.
• Strong computer literacy, including word processing, Smartsheet, SharePoint, PowerPoint and spreadsheet applications.
• Ability to build and maintain strong relationships with laboratory partners, collaborators, and stakeholders.
• Understanding of clinical research and the clinical trial process.
• Advanced planning, organizational, and time management skills.
• Ability to work independently, prioritize tasks, and mentor/lead others.

Responsibilities

• Responsible for interacting closely with scientists who are primarily lab-based, aiding in experimental design where required.
• Serve as the BioA lead on the client's projects, using strategic thinking, scientific knowledge and expertise while working with a range of collaborators and cross-functional groups.
• Act as a Subject Matter Expert in regulated bioanalysis across a range of modalities.
• Contibute to and author regulatory documents to support submissions across a range of countries and geographies.
• Respond to Health Authority questions.
• Ph.D. in analytical chemistry or related field with solid experience (5 years) in Bioanalytical assay development/validation, preclinical and clinical study support or MSc or BSc in relevant subject with 7-10+ yrs solid experience in Bioanalysis required.
• Proven experience as a Subject Matter Expert in regulated bioanalysis across a range of modalities.

Read more below and get ready for your next great employment adventure!

Some of the Perks our LabConnectors Love:

• We truly live our values: People First, Quality Focused, Customer Centered, Technology Driven and Accountability Always.
• The ability to make an impact on a passionate and growing team
• Great communication on a smaller sized team
• A market based salary
• Tools to effectively do your job (laptop, phone reimbursement)

In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities. We believe in a friendly and collaborative environment with open lines of communication. Join our team and discover how your work can impact the lives of people all over the world.

It is the policy of LabConnect to provide equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable law.

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