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Bioanalytical Study Manager
Company values, of problem solving, teamwork, and leadership to enable the highest customer study output possible. A focus on their role as study manager within their team is the highest priority, including participating in internal training schemes, technical learning, being able to plan and manage their workload and to provide technical support to Study Scientists.

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Department: Study Management
Location: BioCity, Scotland
Salary: Starting salary of £36,125+ dependent on experience.
Experience: Degree + Experience in the management of a broad range of customer studies within a contract research organisation or equivalent. • Good knowledge of the analysis of biopharmaceuticals and application of ICH guidelines.

ROLE PURPOSE

The primary purpose of the Study Manager is to support a culture within Antibody Analytics, aligned with the company values, of problem solving, teamwork, and leadership to enable the highest customer study output possible. A focus on their role as study manager within their team is the highest priority, including participating in internal training schemes, technical learning, being able to plan and manage their workload and to provide technical support to Study Scientists.

By working closely with Senior Study Managers, and other senior team members, Study Mangers will ensure that customer studies assigned to them are correctly resourced, scheduled, and executed to meet internal and customer deadlines, with minimal support from senior team members.

ROLE DESCRIPTION

This role requires experience in a range of assay techniques, technical understanding of a wide range of methodologies, ability to work on highly complex projects independently, ability to manage critical reagents, understanding of a Quality Management System, and excellent organisational skills.

PRINCIPLE DUTIES & RESPONSIBILITIES

In addition to the duties and responsibilities of the Junior Study Manager:

Laboratory Techniques

•             Experimental expertise in at least one scientific area encompassing multiple techniques.

•             Capable of training junior staff to a high level of competence.

•             Advanced data analysis skills across a broad range of techniques.

Technical Understanding

•             Clear understanding how assay design impacts data interpretation across a broad range of techniques.

•             Application of high-level technical knowledge to assay development, qualification and validation.

•             Guide Customers in making the best decisions for assay design and data interpretation.

•             Lead complex development studies across a range of technical areas.

•             Identify the relevant technical resources required to design and develop complex assays

•             Support Junior Study Managers if required.

Study Management

•             Independently manage studies including study planning, scheduling, preparation and review of documentation, and customer communication, with support from the Project Lead and/or Senior Study Manager.

•             Prepare protocol, reports and proposals for a wide range of studies, include complex development and qualification studies.

Customer Service (Internal and External)

•             Be able to lead Customer discussions and advise on complex challenges that may arise during a customer study.

•             Support the commercial team in preparing proposals and contracts.

•             Contribute to discussion on research and development projects where appropriate.

Compliance

•             Ensuring adherence to Good Documentation Practices resulting in completed documents, which require minimal revision upon review.

•             Performance of technical review of a wide range of documents including, but not limited to, analytical procedure and laboratory documentation.

Communication

•             Interpersonal skills and teamwork.

•             Effective in the independent management of their time and schedule to actively manage workload.

•             Drives discussions to offer best solutions to balancing project delivery and individual workloads.

•             Demonstration of high awareness coupled with exceptional communication skills to identify and share solutions to potential issues.

Process Improvements

•             Design and implement process improvements ensuring that the studies are operationally efficient to enable the continuous improvement of study management and to simplify and optimise procedures.

Health and Safety

•             Ensure the company is following health and safety regulation and policies to minimise risk in the workplace, including preparation of COSHH and risk assessments.

REQUIRED KNOWLEDGE, EXPERIENCE & QUALIFICATIONS

•             Experience in the management of a broad range of customer studies within a contract research organisation or equivalent.

•             Good knowledge of the analysis of biopharmaceuticals and application of ICH guidelines.

•             Previous experience in assay development or academic research relevant to the company portfolio.

•             Degree in a relevant field with significant laboratory experience or equivalent relevant experience.

REQUIRED SKILLS & ABILITIES

•             Excellent communication and teamwork skills.

•             Technical competence in a range of bioanalytical and immunological methods.

•             Ability to analyse data generated from multiple assay platforms.

•             Strong interpersonal skills.

•             Flexible working attitude.

•             Good organisational and planning skills.

•             Good interpersonal skills.

REQUIRED PERSONAL CHARACTERISTICS

•             Confidence to enforce adherence to defined company procedures.

•             Resilience and ability to work under pressure – ability to troubleshoot and adapt plans at short notice.

•             Honesty and integrity.

•             Exemplary work ethic with respect to meeting deadlines and keeping commitments.

•             Flexibility with problem solving skills to react and amend plans to reflect changing priorities.

•             Confidence and motivation in both themselves and others.

WHAT YOU’LL GET FROM US
You will get the chance to learn, grow, develop, and enhance your career within a biotechnology company at the forefront of drug development strategies. In addition, the company offers the following benefits package:
• Starting Salary £36,125 + dependent on experience, which is linked to performance related pay
• Pension
• 32 days holiday per annum (inclusive of public holidays) which increases to a maximum of 37
• Access to a 24/7 virtual GP
• Merit Award Recognition Scheme
• Free Healthy Snacks
• Yearly Audible subscription
• Refer a Friend Scheme
• Death in Service Benefit
• The opportunity to join several committees or focus groups (Employee Engagement, Wellness, Recognition, Health & Safety or Social Committee)

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