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.

Role

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.
• Role
• 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
• Qualifications/Experiences
• 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

  • 2a Foster Drive,
    Cardiff,
    CF23 9BZ
  • Mobile 07968 551450
  • Email justyn.withey@justlifesciences.com