Bioanalytical Program Lead - Sweden

LabConnect; Göteborgs kommun; Remote; SEK 900,000 - 1,100,000; Full time

Benefits offered by this job

People First

Global team

Quality focus

Career growth

Job summary

LabConnect is hiring a Bioanalytical Program Lead to design and implement robust bioanalytical strategies across a global team. The role ensures lab activities align with study context while coordinating with scientists to manage experimental design and tech transfer in regulated bioanalysis.

Remote role, best suited for candidates near Gothenburg. The candidate will act as the client project bioanalytical lead, contributing to regulatory documents and interacting with Health Authorities to

Qualifications

• Bachelor's degree in a relevant science field.
• 10+ years of experience in bioanalysis.
• Proven SME in regulated bioanalysis across modalities PK/CK, PD, immunogenicity.
• Led bioanalytical strategy across projects including biomarkers and dose endpoints.

Responsibilities

• Interact with lab-based scientists to aid experimental design.
• Serve as bioanalytical lead on client projects with cross-functional teams.
• Act as SME in regulated bioanalysis across modalities.
• Contribute to regulatory documents to support submissions in multiple geographies.
• Collaborate with regulatory agencies to mitigate risk and respond to questions.

Skills

Bioanalysis

Regulatory knowledge

Experimental design

Cross-functional collaboration

Scientific writing

English language

Education

Bachelor of Science in relevant subject

Job description

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.

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

TheBioanalyticalProgramLead,supporting anIntegrated Bioanalysis (IBA) Global Team,willleadthe design and implementation of robust bioanalytical strategies.This role willensure lab-based activities are aligned with context of use, workingclosely with other scientific and technical labstaffin a matrix environment to manage aspects such as experimental design and tech transferin regulated bioanalysis supporting therapeutic modalities across a range of therapeutic areas.

Please note: this is a remote role best suited for candidates within proximity to Gothenberg.

Essential Duties And Responsibilities

• Responsibleforinteractingcloselywithscientistswhoareprimarilylab-based,aidingin experimental designwhererequired.
• Serveasthebioanalyticalleadontheclient’sprojects,usingstrategicthinking,scientific knowledgeandexpertisewhileworkingwitharangeofcollaboratorsandcross-functionalgroups.
• ActasaSubjectMatter Expert inregulatedbioanalysisacrossarangeofmodalities.
• Contributeto andauthorregulatorydocuments 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 respondto Health Authorityquestions.

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 [e-mail] or call [phone].