Overview
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.
Job Summary
The Bioanalytical Program Lead, supporting an 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.
Please note: this role is best suited for candidates within proximity to Cambridge.
Essential Duties and Responsibilities
- Responsible for interacting closely with scientists who are primarily lab-based, aiding in experimental design where required.
- Serve as the bioanalytical 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.
- Contribute to and author regulatory documents to support submissions across a range of countries and geographies.
- Work with regulatory agencies and Health Authorities across a range of countries and geographies to mitigate risk, submit regulatory documents, and respond to Health Authority questions.
Education and Experience
- Bachelor of Science in relevant subject required.
- At least 10 years of experience in Bioanalysis required (large and small molecule).
- Proven experience required as a Subject Matter Expert in regulated bioanalysis across a range of modalities PK/CK, PD and immunogenicity assessments (cellular and humoral).
- Required experience as a bioanalytical lead across diverse project teams - defining, leading and executing on bioanalytical strategy to advance a portfolio that may include Biomarker and Target Engagement strategy for dose decision endpoints.
Skills and Ability
- Required scientific ability to assess and discern the advantages and pitfalls of a range of analytical techniques which may include molecular assays (ddPCR, 1PCR, RT-qPCR), flow cytometry, ELISpot, viral assays, cytokine assays, ligand binding assays and Mass Spectrometry.
- Requires deep understanding of small and large molecule Bioanalysis.
- Requires proven publication and presentation record.
- Requires exceptional written and verbal communication skills.
- Requires proficiency in speaking and writing in the English language.
- Preferred knowledge of immunology and/or metabolic diseases.
- Preferred experience working in a matrix environment.
Supervisory Responsibilities: None
Physical Demands:
While performing the duties of this job, the occupant is regularly required to:
- Prolonged periods of sitting at a desk and working on a computer.
- Prolonged use of computer and headphones for conference calls.
- Communicate effectively via phone, video, and email.
- Use hands and fingers to operate a computer and other office equipment.
Join our team and discover how your work can impact patients' lives around the world!
Some of the Perks our LabConnectors Love:
- We truly live our values: People First, Quality Focused, Customer Centered, Technology Driven and Accountability Always
- The opportunity to make a meaningful impact on a passionate and growing team
- Strong communication and collaboration within a smaller sized team
- Access to tools and resources that empower you to excel in your role
In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication.
We are proud to be an Equal Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic.
LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with the General Data Protection Regulation (GDPR). For this job posting, all hiring decisions are made with meaningful human involvement and consideration. In this context, no applicant is subject to a decision based solely on automated processing within the meaning of Article 22 of the GDPR.
To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/
If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect - please email
[email protected] or call +1 (423) 722-3155.
