Bioanalytical Project Manager - Scientific Operations
Remote - US, 2304 Silverdale Drive, Johnson City, Tennessee, United States of America ● Sandwich, UK Req #471 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 Title:
Bioanalytical Project Manager (Large Molecule Bioanalysis) Job Purpose: To consult and provide technical expertise and project management across a range of bioanalytical activities on behalf of A4P’s contracted customers. This includes the oversight of outsourced bioanalysis at contract research organisations for clinical and pre-clinical drug development. Job Role: 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, including 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. Job Location: The role can be undertaken from home or from the A4P offices at Innovation House, Discovery Park, Sandwich, UK. For a home-based employee, travel on a needs-to basis to the A4P / LabConnect offices will be required on occasion. Additionally, the role may involve travel to customers or vendor’s sites, as requested. Required Experience: 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. 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. Personal Characteristics: 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. Salary and Benefits: Salary negotiable with reimbursable travel expenses. A4P operates a discretionary rewards and recognition scheme for performance. A4P offers 25 days annual paid leave (excluding public holidays). Hours of Work: This position is a full-time role based on 37.5 hrs. per week, excluding lunch & holidays with an initial 3-month probationary period. A4P operates a degree of informal flexibility with regards to working hours. This is a remote position. Read more below and get ready for your next great employment adventure!
Some of the Perks our LabConnectors Love:
We truly live our values:
partnership, excellence, execution, collaboration, forward thinking, accountability, informed
and
nimble 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) We are a growing and global team on a mission to create healthier communities by accelerating the development of new medicines. 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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Remote - US, 2304 Silverdale Drive, Johnson City, Tennessee, United States of America ● Sandwich, UK Req #471 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 Title:
Bioanalytical Project Manager (Large Molecule Bioanalysis) Job Purpose: To consult and provide technical expertise and project management across a range of bioanalytical activities on behalf of A4P’s contracted customers. This includes the oversight of outsourced bioanalysis at contract research organisations for clinical and pre-clinical drug development. Job Role: 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, including 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. Job Location: The role can be undertaken from home or from the A4P offices at Innovation House, Discovery Park, Sandwich, UK. For a home-based employee, travel on a needs-to basis to the A4P / LabConnect offices will be required on occasion. Additionally, the role may involve travel to customers or vendor’s sites, as requested. Required Experience: 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. 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. Personal Characteristics: 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. Salary and Benefits: Salary negotiable with reimbursable travel expenses. A4P operates a discretionary rewards and recognition scheme for performance. A4P offers 25 days annual paid leave (excluding public holidays). Hours of Work: This position is a full-time role based on 37.5 hrs. per week, excluding lunch & holidays with an initial 3-month probationary period. A4P operates a degree of informal flexibility with regards to working hours. This is a remote position. Read more below and get ready for your next great employment adventure!
Some of the Perks our LabConnectors Love:
We truly live our values:
partnership, excellence, execution, collaboration, forward thinking, accountability, informed
and
nimble 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) We are a growing and global team on a mission to create healthier communities by accelerating the development of new medicines. 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.
#J-18808-Ljbffr
