Pharmaceutical Development Scientists
- Reference: PPD
- Location: Cardiff
- Salary: Upto £46000
- Type: Full time
Just Life Sciences are working with their Global Pharma client, who are establishing a newly created team around Pharmaceutical Process Development and we require a suitably qualified Senior Pharmaceutical Development Scientist.
The role requires the individual to lead a small team of scientists and manage multiple complex pharmaceutical development, transfer and scale up projects.To provide technical expertise in pharmaceutical development, transfer and scale up over a range of dosage forms.To be client focused and deliver projects to agreed timelines and milestones.
Qualifications, Skills and Experience
- Just Life Sciences are working with their Global Pharma client, who are establishing a newly created team around Pharmaceutical Process Development and we require a suitably qualified Senior Pharmaceutical Development Scientist.
- The role requires the individual to lead a small team of scientists and manage multiple complex pharmaceutical development, transfer and scale up projects.To provide technical expertise in pharmaceutical development, transfer and scale up over a range of dosage forms.To be client focused and deliver projects to agreed timelines and milestones.
- ·Lead multiple complex pharmaceutical development, technical transfer and scale up projects.
- ·Able to act as SME for assigned process/projects to support all internal and external needs, including client visits and regulatory audits.
- ·Responsible for generation of various gap analysis e.g. excipient, process, equipment, training to support efficient and effective on-boarding of NPI manufacturing process.
- ·Responsible for the generation of technical protocols to allow generation of required batch documentation by Associate Process Scientist.Generation of DOE protocols to support development activities
- ·Responsible for the reviewing and generation of manufacturing batch records for development, technical transfer, scale up and validation in accordance with cGMP practices.Ensure batch documentation is available to agreed SLA.
- ·Responsible for the analysis and interpretation of complex data sets e.g. DOE results using statistical tools including JMP, Minitab and Design Expert.
- ·Responsible for the generation of Development, Transfer and Scale up manufacturing reports within agreed SLA to support achievement of project milestones.
- ·Ensure up to date engineering solutions and technologies are employed when working on new projects
- ·Advise and support CAPEX and/or improvement activities in the manufacturing area required to support client projects.
- ·Lead Complex deviation investigations using RCA tools to determine Root cause and support CAPA implementation.
- ·Liaise with all functions to ensure that production schedules are adhered to 100% of the time where this is possible.
- ·To communicate effectively with internal and external customers and participate with them in problem solving and continuous improvement activities
- ·Responsible for progressing and assisting in the technical aspects of manufacturing process validation exercises, including the generation of QRM/FMEA and identification of CQAs, CPPs and Drug Product CQAs
- ·To conduct necessary briefings and training of manufacturing personnel where required, promoting best practices for development batch manufacture, technical transfer and scale up. (E.g. ICH/ISPE)
- ·To manage performance of direct reports and process all HR and departmental documentation including; sickness related documents, absence request forms, staff appraisals including 1:1s, probationary reviews and PMRs, PDPs and disciplinary procedures in line with company requirements
- ·To observe safe working practices in handling of materials and when conducting manual handling activities
- ·To comply with Company Policies, including HSE and environmental standards for the handling of potent products down to OELs of 0.01µg/m3
- ·To identify self-development needs for future performance and those of direct reports, implement through PDP.
- ·To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities and responsibilities
- ·Degree in a suitable scientific discipline (e.g. chemistry, pharmacy, microbiology, engineering)
- ·Higher Degree in a suitable scientific discipline (e.g. chemistry, pharmacy, microbiology, engineering) or equivalent experience
- ·Knowledge of Potent molecules and other dosage forms Technical transfer and scale up of manufacturing process.
- ·Knowledge of EMEA/FDA/ and Japanese markets
- ·Experience of leading and development of small team of technical specialists
- ·Extensive experience in Pharmaceutical development and manufacturing processing environment, ideally in OSD/Liquids
- If you have the relevant experience and are looking for a new role within Pharmaceutical Development then please contact justyn at justlifesciences dot com or call 07968 551450
Just Life Sciences
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