Job Number: 1614956
Unique opportunities in the provision of scientific analysis, research, consultancy and training to its parent company and the wider food and pharmaceutical sectors. Operating as Reading Scientific Services Ltd (RSSL), we apply leading-edge science with integrity and service to exceed expectations and deliver greater value to our clients.
In RSSL we are customer focused, science led and results driven. The RSSL Pharmaceutical Development laboratory performs a wide range of analytical analyses for a variety of food, pharmaceutical and healthcare companies.
The role at Scientist II is to be responsible for leading the suite of stability projects from within the Pharmaceutical Development team. This role will take specific responsibility for coordinating the stability programme, including the GMP compliant running of the stability cabinets to ICH guidelines. You will be expected to play a key role in ensuring that stability projects are managed effectively within the relevant departments and that the customers’ requirements and contractual agreements are fulfilled in a timely manner. The supervision and training of junior members of the team within stability and supporting functions (i.e. out of hour monitoring pager programme) will be required.
- To coordinate the stability programme through efficient project management, authoring and approval of stability protocols and advise on potential business opportunities and areas of future growth.
- Take responsibility for the efficient and compliant running of the stability cabinets to GMP requirements and ICH guidelines.
- Arrange and supervise onsite engineers and take responsibility for ensuring that the appropriate service level agreements, contracts and approved providers are current and meet GMP requirements and business needs.
- Work in an organised manner within tight deadlines to ensure that all stability procedures are completed within expected timelines. This may include stability set downs, stability pulls, writing and reviewing stability protocols, writing stability reports, administrating photo-stability exposures, issuance of stability certificates and producing quotations for clients.
- Provide high quality customer service at all times by ensuring effective workflow within the assigned area of responsibility, integrity of analytical data generated and timely/accurate provision of results.
- Assist with client stability queries and represent RSSL in a professional manner at all times.
- To help maintain the quality systems and represent the stability programme in both client and regulatory audits.
- Contribute to RSSL’s Emergency Response Service (ERS) and to the stability programmes out-of-hours monitoring service.
- Be proficient in the use of generic and specific software packages required for the role: e.g. Laboratory’s LIMS system, Q-Pulse document system, Eurotherm monitoring system.
- Assist in the supervision, training and development of junior staff.
- Take responsibility as required for other elements of specific projects and/or specific areas of general laboratory and/or sample administration.
Will be expected to work in different laboratories if the demand is required.
Communication & Influence
- Work as part of an efficient analytical team
- Participate in the preparation of client quotes
- Deliver internal presentations across groups
Leadership and supervision
- Supervise and train junior members of the team in stability practices, and others within the business who are associated with the out of hours monitoring service.
- Work to the highest standards of safety and quality by ensuring that appropriate COSHHs, risk assessments and SOPs are are understood and followed.
- To complete assigned quality actions in a timely manner.
- Assist with the documentation of SOPs, generation of Risk Assesments and COSHH.
- To maintain a clean, tidy and safe working environment.
- To understand and work to the requirements of GMP, ICH and UKAS.
- Ensure training records are up-to-date and accurate.
- Know the ethical and legal compliance responsibilities of the position; raise questions and concerns when faced with an ethical or compliance issue; apply integrity in all aspects of professional conduct
- Educated to Degree in a relevant scientific discipline or equivalent relevant experience in a laboratory.
- Good understanding of Stability chambers and practices, the ICH guidelines, and lab equipment (e.g. HPLC, dissolution, FT-IR, UV)
- Accountable, honest, hardworking and able to work efficiently in a team.
- Flexible and adaptable to meet customer/business requirements.
- Meticulous attention to detail and an ability to follow written instructions
- Good written and verbal communication skills.
- Self motivated, enthusiastic and quick to learn.
- Able to organise own work to maximise output
- Well organised and capable of working on multiple activities concurrently.
- Computer literate in standard MS office applications
- Experience of working with stability storage projects and a familiarity with the ICH guidelines relating to stability storage.
- Experience of working in a GMP environment.
- Scientific understanding and the ability to independently conduct project management in the relevant areas
- Demonstrate ability to manage projects independently and as part of a team within defined parameters such as timescales and contractual agreements.
- English fluency (written and spoken)
We pride ourselves on having a high performing and collaborative culture where we offer support and development to enhance your career and develop your knowledge and skills.
In return for your commitment, drive and enthusiasm, we offer an attractive benefits package within a highly successful International business that offers financial rewards and resources, including bonus scheme, contributory pension, life assurance, generous holiday allowance and a flexible benefits programme.