Be an early applicantLess than 25 applicants

Company

LabConnect · 4 hours ago

Bioanalytical Project Manager - Scientific Operations

Johnson City, TN

Contract

Remote

Senior Level, Lead/Staff

10+ years exp

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BiotechnologyHealth Care

H1B Sponsor Likely

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Responsibilities

Oversight and management of method development, validation and sample analysis studies at contracted CROs.

Provide technical input in the application and operation of quantitative bioanalytical techniques.

Provide technical and regulatory expertise on bioanalytical strategies during client meetings and ensure regular updates on progress of outsourced activities to customers.

Interact effectively with client’s stakeholders. This will include but not be limited to outsourcing experts, data managers, pharmacokinetic and pharmacology experts, procurement and/or bioanalytical sample managers.

Source, select and engage with appropriate bioanalytical CROs for customer outsourced activities.

Review bioanalytical data generated by CROs.

Review draft validation and bioanalytical analysis plans, reports and study documents.

Ensure effective communication and management strategies with contracted CROs.

Monitor CROs activity and KPIs as required by customers.

Oversight of biosample operations, support to central lab set up, kit provision to sites and sample lifecycle.

Contribute to the development of A4P and LabConnect products and services.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Bioanalytical project managementMethod developmentValidationQuantitative bioanalytical techniquesPK/PD analysisBiomarker analysisImmunogenicity analysisLigand binding assayRegulatory standards knowledgeClinical study designCRO managementPCRFlow CytometryEU IVDR knowledgeFDA regulations knowledgeRegulatory submissions inputClient relationship development

Required

Degree/ master's level equivalent in a biochemistry/ biological science or similar discipline with a minimum of 10 years relevant experience in regulated bioanalysis.

Extensive knowledge of PK / PD, biomarker and immunogenicity analysis within regulated environments (GLP / GCP).

Comprehensive knowledge of ligand binding assay associated analytical platforms.

Practical experience of managing and developing bioanalytical methods, assay validation and study data generation in clinical and pre-clinical studies.

Experience in the pharma and/or CRO industry supporting regulated bioanalysis.

Knowledge of the latest regulatory standards required for GXP studies, including international guidance published by regulatory agencies.

Knowledge in design and operational execution of clinical and pre-clinical studies.

Significant understanding of the research activities within a drug development organisation.

Engaging, enthusiastic, self-motivated, solution oriented, confident and a team player. Able to interact with both large global and emerging start-up organisations.

Capable of prioritizing activities and multi-tasking across several deliverables.

Strong attention to detail.

Excellent verbal and written communication skills.

Keen to learn and provide and receive constructive feedback.

Able to gain client’s trust and confidence in A4P capabilities.

Able to develop effective relationships with external service partners.

Available to travel and work at customer site(s) for short periods of time.

Willing to travel

Preferred

Experience in the analysis of complex modalities including ADC’s, multi-domain molecules, Fab constructs, etc.

Experience of PCR and/or Flow Cytometry to support drug development.

Knowledge of EU IVDR / FDA regulations.

Previous experience managing contract research organisations.

Experience of input to regulatory submissions.

Benefits

25 days annual paid leave (excluding public holidays)

Discretionary rewards and recognition scheme for performance

Laptop, phone reimbursement

Company

LabConnect

LabConnect provides global central laboratory services

Founded in 2002

Johnson City, Tennessee, USA

501-1000 employees

https://www.labconnect.com/

H1B Sponsorship

LabConnect has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2020 (1)