Project Leader

1 week ago

Macclesfield, United Kingdom Synexa Life Sciences Full time

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 of 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.
- At least 1 - 2 years’ experience working in a bioanalytical laboratory.
- 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.
- 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**:
**Why Join Us?**

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
- Locally applied benefits per country, including annual leave and competitive pension contributions.
- Training and Development opportunities
- 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 SUMBITTED IN ENGLISH._

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