Overview

Reference Number: JO-1911-441664
Associate Bioanalytical Manager
Rate: Negotiable
Job Type: Permanent
Location: Cambridge

Our client, a clinical-stage biopharmaceutical company developing a deep pipeline of novel antibody-based therapies in a broad range of indications, is looking for a highly motivated Scientist to assist with the technical, contractual, logistical & regulatory oversight of outsourced bioananlytical methods for phamacokinetics, immunogenicity, cell/tissue and soluble based biomarkers, as required to support the progress of their therapeutic antibody candidates through pre-clinical & clinical development.

The Company generates its product candidates using its proprietary, integrated platforms that have been designed to maximize the diversity of human antibodies produced in response to immunization with antigens. Selecting from a broad diversity of fully human antibodies allows for the identification of antibodies with optimal drug-like properties.

Key duties/responsibilities:

This role will be non-lab based & will predominantly be assisting the management of bioanalytical development activities across multiple development project, primarily through outsourced studies but also including some limited input into in-house lab activities.

Work within project & cross-functional teams, contributing to defining & managing bioanalytical support, particularly PK & immunogenicity.

Help to identify and select appropriate external contractors or service providers for each work package and ensure that the pre-clinical and clinical project requirements are met by:
• Contractual engagement according to company SOPs
• Reviewing study protocols, work plans, analytical methods and costs to fit project timeline and budget
• Monitoring and management of contractor performance to ensure study completion according to agreed quality standards, timelines and costs

Review and finalisation of bioanalytical data, study documentation and formal reports

Assist with compilation and documentation of relevant bioanalytical documents to support successful IND or CTA filings.

Keep up to date with relevant regulatory guidance’s and bioanalytical industry best-practice applicable to GLP, GCP and GCLP.

Communicate, to line management and other stakeholders as appropriate, progress and identified risks and issues arising on bioanalytical matters.

Key requirements:

Education/Experience

• BSc/MSc in relevant discipline or equivalent industrial experience
• Experience of analysing product quality attributes for biopharmaceuticals
• Experience in documenting analytical data to support regulatory filings
• Experience in analytical method development and/or writing SOPs is desirable
• Experience in working with CMOs is desirable
• Experience in SPR and/or mass spectrometry techniques is desirable
• Experience of using (and programming) liquid handling platforms is desirable

Skills/Knowledge

• Competent in liquid chromatography (reversed phase, size exclusion, IEX) and capillary electrophoresis techniques
• Knowledge of protein biochemistry in relation to biopharmaceutical development
• Highly organised, able to prioritise work, work well under pressure and meet deadlines
• Excellent communication and organizational skills
• Maintain a high standard of professionalism when representing the Company both internally and externally
• Ability to work in a flexible, collaborative style with colleagues and teams within the company and with external CMOs

Can you see yourself being part of a company that celebrates diversity and believes that better thinking and decisions come from wider experience? If the answer is yes and you have a desire to be an integral part of a dynamic team, we would be keen to hear from you. In the first instance, please send your CV to Matthew Walsh: matt@scientificprofessionals.com . We endeavour to come back to you within 24 hours of CV submission.

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