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Reading Scientific Services Ltd (RSSL) is a cutting-edge Contract Research Organisation (CRO), providing research, analysis and consultancy to the life science, healthcare and food sectors.
As a senior scientist, the role of Chromatography Expert is to provide analytical expertise across the breadth of Pharmacopoeia and client methodology required during the drug life cycle.
The scope includes troubleshooting and optimisation of pharmacopeia methodology, verification of analytical methods for excipients, APIs and biologics and driving client drug delivery programs from the raw materials through to their finished products and stability studies.
The Senior Scientist II role will play a key role in ensuring that chromatography projects within the Pharmaceutical Development laboratory are performed and supervised effectively and accurately within agreed timescales and to appropriate quality standards. The role will coach a team of scientists, providing technical direction, and will be responsible for reviewing and authorising of certificates of analysis, interpretive scientific reports, verifications and validations and authorizing competencies within the area of expertise.
Primary Accountabilities / Responsibilities :
Technical
Provide high quality customer service at all times by ensuring effective organisation of assigned workload, integrity of analytical data generated and timely/accurate provision of results.
Responsible for a portfolio of analytical projects including verification, validation and transfer of pharmaceutical chromatographic methodology.
Implementation of solutions to technical pharmacopoeia challenges and support creation of new business opportunities
Perform data checking and provide interpretation of results for routine and complex testing
Generate certificate analysis and external interpretive reports.
Expert user in the use of software packages relevant to the role, Laboratory’s LIMS system, Q-Pulse, Chemwatch, Openlab.
Provide training and supervise staff in routine activities, methods and interpretation.
Provide technical direction in area of expertise within and across departments, including maintenance and troubleshooting of laboratory equipment.
Communication & Influence
Work as part of an efficient analytical team
To liase with clients, business development and line management to ensure effective communication of project proposals and results.
Provide expert advice and lead client and stake holders meetings and audits
Deliver presentations to clients and stakeholders
Contribute to both technical and business strategy including influencing senior management
Leadership and supervision
Use Technical expertise to coach/ mentor a team of Scientists and Technicians
Plan own workload and projects for junior staff
Train and coach junior members of the team as required.
QEHS
Work to the highest standards of safety and quality by ensuring that appropriate COSHHs, risk assessments and SOPs are understood and followed.
To complete, review and approve assigned quality actions on a timely manner.
Write, approve and review SOPs and Test Methods
Generation and approval of Risk Assessments and COSHH
Understand and provide technical regulatory leadership in client audits
To ensure the maintenance of a clean, tidy and safe working environment for both yourself and members of the team
To understand and work to the requirements of GMP; including client specific quality requirements and pharmacopeia requirements.
Ensure training records are accurate for both yourself and members of the team.
Knowledge, Skills, Experience and Language Requirements :
Educated to Degree or PhD in a relevant scientific discipline or over 8 years of industry experience
Excellent understanding of pharmaceutical lab equipment, HPLC, Dissolution, Karl Fischer, Stability Cabinets, etc.
In-depth knowledge of both technical area of expertise & business environment including regulatory requirements
Good knowledge of laboratory quality and accreditation systems (GMP)
Strong written and spoken communication skills, with the ability to influence, network and manage internal/external relationships.
Excellent organisational skills including time management and priority setting. Able to lead resource allocation in order to deliver projects to tight timescales.
Meticulous attention to detail, well organized and strong team working ethos.
Experienced in managing and mentoring staff
Technical credibility to develop good working relationships with internal and external clients.
Ability to solve complex analytical problems
Computer literate in standard MS office applications
The individual in this position has extensive experience in their discipline (both technical and regulatory) and has a demonstrated track record of applying their knowledge across different business areas.
Proven experience in Analytical Project Management
Experience in pharmaceutical laboratory quality systems (GMP)
English fluency (written and spoken)
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:
Opportunities to learn and develop
Flexible working
Performance Related Bonus scheme
Contributory pension (up to 11% employer contribution)
Life assurance
Private medical insurance cover (can add partner and/or family) if applicable
27 days holiday allowance (possibility to buy 5 extra days) + bank holidays
Employee Assistance Programme (EAP)
A flexible benefits programme (Gym discounts, private health insurance, restaurant discounts, etc).
Reading Scientific Services Ltd (RSSL) is a cutting-edge contract research organisation (CRO), providing research, analysis and consultancy to the food, consumer goods and life science sectors. Whether we are creating new products, validating medicines or solving investigations, we take pride in being a leader in our field, serving clients from across 70 countries. Enriched by our parent company, Mondelēz International, our team are committed to transforming lives through science, innovation and collaboration.
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RSSL is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, gender, sexual orientation or preference, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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Analytical Science
Science & Engineering