Passionate about advancing healthcare? We provide bioanalytical services and we’re leading biomarker research to transform patient outcomes. Join our dynamic team and make a global impact. Explore exciting career opportunities with us today! Our brand-new facility has a wealth of state-of-the-art Scientific instruments, and we are based in Macclesfield in the heart of Cheshire.
We’re looking for a detail-oriented professional who can identify areas for improvement and support our compliance program, helping to uphold our commitment to excellence and innovation. With our rapid growth, this is a unique opportunity to shape your career and make a tangible impact on our success.
Job Purpose:
As Project Leader you will be responsible for ensuring the scientific integrity of any project under your control and effectively managing communication with your clients.
Main Responsibilities:
* Be the key contact for clients for assigned studies.
* Act as Study Director / Principal Investigator / Project Leader (Responsible Scientist) for assigned regulatory studies.
* Understand client requirements and timescales, liaising with Business Development Executives in the production of quotes as required.
* Develop and manage effective communication with clients for assigned studies.
* Review client documentation such as study protocols, lab manuals, data transfer agreements. Request and schedule appropriate resource to ensure timely completion of assigned studies.
* Preparation of bioanalytical study or study phase plans and other documents.
* Regular communication with scientific staff performing analysis for assigned studies, managing their workload and planning tasks they should perform on a daily basis.
* Review and sign off study data.
* Responsible for scientific integrity and regulatory compliance of assigned studies.
* Ensure the data and laboratory processes are in accordance with GLP/GCP and good documentation practice.
* Delivery of interim and final data to the client to agreed timescales.
* Preparation and delivery of bioanalytical reports.
* Responding to QA audits.
* Involvement in client audits.
* Provide regular study updates to Project Leader Management.
* Preparation and Review of SOPs.
Minimum Candidate requirements:
* At least 1 - 2 years’ experience working in a bioanalytical laboratory.
* A degree in life sciences or chemistry related subject.
* A good communicator with strong interpersonal skills.
* Experience of working within a GLP/GCP accredited facility.
Additional Requirements:
* You must be flexible and adaptable with excellent attention to detail.
* Good computer literacy and competent in Microsoft office applications Outlook, Powerpoint, Word, Excel.
* Hands on experience of using LC-MS/MS and Immunoassay technologies.
* Knowledge of scientific software platforms such as Analyst, Masslynx, UNIFI, WATSON, Softmax Pro, and ELN an advantage.
* Experience of Validating Methods to FDA/EMA guidelines an advantage.
* Experience of Bioanalytical Method Development an advantage.
Skills and Competencies:
Excellent computer literacy and competent in Microsoft office applications Outlook, Powerpoint, Word, Excel.
Why Join Us?
We offer a competitive remuneration package, including salary, holidays, and benefits. If you’re ready to advance your career in a dynamic, supportive environment, we encourage you to apply and join us on our journey to excellence.
In addition, we offer the following:
* Social events & end of year function
* Family friendly leave for sick, paternity, maternity and parental
* Regular communication and engagement through BambooHR announcements and Town Hall meetings
* Regular employee engagement surveys
* Statutory/Public Holidays – flexible to be taken when chosen or on the actual public holiday (subject to management approval).
* Locally applied benefits per country, including annual leave and competitive pension contributions.
* Training and Development opportunities
* Annual Inflationary increases to salary (subject to budget and inflation)
* Strong applicant tracking system for recruitment and ensuring the onboarding process is an enjoyable experience for all new employees.
PLEASE ENSURE THAT YOUR CV/RESUME IS SUBMITTED IN ENGLISH.
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