Mondelez International Pharmaceutical Development Technical Specialist in READING, United Kingdom
In RSSL we are customer focused, science led and results driven. The RSSL Pharmaceutical Development laboratory performs a wide range of projects relating to analytical development, stability and release for pharmaceutical and healthcare companies. The department also provides analytical support to formulation, cleaning validation and impurity isolation and sample purification.
The role of Pharmaceutical Development Technical Specialist is to provide strong technical direction and leadership in supporting our clients on early phase research. The successful candidate will operate at a senior level by leading initiatives as well as managing a small team.
The role is a technical leader position, which interfaces with all levels in the organisation, where the individual actively uses their network of external contacts to achieve technical / business objectives.
The individual in this position must have an excellent understanding of the pharmaceutical industry and associated regulatory responsibilities. The role contributes to business through leading and growing a number of scientific and technical disciplines whilst working to GMP quality standards.
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 projects or a technically complex multidisciplinary project across different technical groups.
Responsible for initiating/running internal projects to improve operational efficiency across the company.
Perform data checking and provide interpretation of results for analytical work.
Write, review and authorise interpretive scientific reports including complex method development procedures and validation protocols
Provide training, supervise both junior and senior staff in method development and interpretation, and authorise competencies within the area of expertise.
Identify and drive improvement efficiency opportunities.
Provide technical direction in a wider area of expertise across departments.
Perform and instruct best practice for the maintenance and troubleshooting of lab equipment.
Expert user in the use of generic and specific software packages require for the role: Laboratory’s LIMS system, Q-Pulse, OpenLab, QlikView.
Communication & Influence
Work as part of an efficient analytical team.
To liaise with clients, business development and line management to ensure effective communication of complex project proposals and results.
Provide expert advice and lead client and stakeholder meetings as required.
Represent RSSL as a subject matter expert in external meetings and events delivering external presentations when required.
Influence externally, for example within the pharmaceutical industry and associated government bodies.
Make an authoritative and expert scientific contribution to business strategy, and provide strong technical and regulatory leadership.
Leadership and supervision
Demonstrate effective people management, development and coaching of those within and outside their team. The incumbent is expected to provide the appropriate level of supervision and leadership.
Support recruitment initiatives.
Responsible for helping to maintain technical and compliance capability within their team in their area of expertise.
Demonstrate strong organisational skills and a keen eye for detail.
Work to the highest standards of safety and quality by ensuring that appropriate COSHHs, risk assessments and SOPs are understood and followed.
To complete assigned quality actions on a timely manner, including review and approval.
Write and approve SOPs and Test Methods.
Generation and approval of Risk Assessments and COSHH.
Understand and provide technical regulatory leadership in client audits.
To maintain a clean, tidy and safe working environment.
To understand and work to the requirements of GMP.
Ensure training records are accurate.
Educated to Degree, MSc or PhD in relevant scientific discipline or equivalent relevant experience in a laboratory.
Proven track record of laboratory experience in early phase product development, API and drug product stability studies and batch release.
In-depth knowledge of both technical area of expertise and business environment including regulatory requirements.
Excellent knowledge of laboratory quality and accreditation systems (GMP).
A strong track record of analytical development and validation with industry experience.
Experience managing technical projects independently and have regulatory knowledge of all phases of drug development, particularly early phase.
Proven experience of authoring technical reports and presenting findings at relevant symposia.
Strong written and verbal communication skills, with the ability to influence, network and manage internal/external stakeholders.
Ability to complete projects within tight timescales and adapt to rapid changes in project priorities.
Meticulous attention to detail, well organized and strong team working ethos. Able to organize own work and others to maximize output.
Ability to motivate and mentor scientific staff.
Technical credibility to develop good working relationships with internal and external clients.
Ability to direct complex analytical problem solving.
High levels of business acumen, with strong ability to interpret, deliver and create new business opportunities.
Computer literate in standard MS Office applications.
English fluency (written and spoken).
- Experience of working for, or with, a CRO
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.
RSSL website: https://www.rssl.com/
YouTube channel: https://www.youtube.com/user/RSSLServices
LinkedIn page: https://www.linkedin.com/company/107107
Title: Pharmaceutical Development Technical Specialist
Requisition ID: 1708235