Pharmaceutical Stability Manager
Reading Scientific Services Ltd (RSSL) is a leading edge science consultancy offering research, analysis, training and consultancy to our clients globally, primarily blue chip food and pharmaceutical companies. We do with passion, integrity and service to exceed expectations and deliver enhanced value to our clients.
Not only that but we’re supporting our parent company – Mondelēz International – where we operate as the Reading Science Centre. That means we’re both agile and autonomous whilst enjoying the development and growth of being connected to the biggest snacking company in the world.
Purpose of the role:
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 and supports Mondelez research and innovation.
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.
- This may include stability set downs, stability pulls, writing and reviewing stability protocols, writing stability reports, administrating photostability exposures, issuance of stability certificates and producing quotations for clients.
- Provide high quality customer service to RSSL/Mondelēz 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.
- 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.
- Will be expected to work in different laboratories if the demand is required.
- Participate in the preparation of client quotes
- Deliver internal presentations across groups
- 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 understood and followed.
- Assist with the documentation of SOPs, generation of Risk Assessments and COSHH.
- 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)
- Good written and verbal communication skills.
- 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.
Please be aware that this role may require handling of materials that may contain chemicals, solvents and allergens, and the appropriate protective wear will be supplied.