Job Title: Project Leader
Department: Project Leader Group
Contract Type: Permanent
Working Hours: 37.5 hours per week
Alderley Analytical is fast growing Contract Research Organisation (CRO) located on the Tytherington Business Park, near Macclesfield in the heart of Cheshire. We provide specialist bioanalytical services to support our clients with their discovery and regulatory drug development programmes. We provide services to support our clients with their small & large molecule, peptide, oligonucleotide and biomarker projects.
Our facility has a wealth of state-of-the-art LC-MS/MS instruments complimented by many other analytical technologies.
Due to the ongoing success of Alderley Analytical, we are looking to grow our Project Leader Group. We are offering entry level positions with a structured training program for a candidate that is hardworking, ambitious and enthusiastic in building a career in scientific project management. We are also offering more senior positions for candidates that already have experience of acting as a Study Director / Principal Investigator / Responsible Scientist in a regulated environment.
Alderley Analytical will offer the successful candidate an interesting and fulfilling career, along with an excellent renumeration package including a competitive salary, generous holidays and pension fund.
- Be the key contact for clients for assigned studies.
- Act as Study Director / Principal Investigator / Project Leader (ResponsibleScientist) 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, datatransfer 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 3 years’ experience working in a regulatory 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.
- 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, Sciex and Waters LC-MS/MS systems an advantage.
- 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.
- An understanding of Large Molecule analysis and non-LC-MS/MS techniques an advantage.