Position: Associate
Job type: Full-time
Job content
VQ Life Sciences are recruiting for a permanent Senior Development Chemist with experience of formulation in the pharmaceutical industry and regulations for a client based in Skipton, Yorkshire. The Company Our client is an international specialist veterinary pharmaceuticals products business. Their expertise lies in the development, manufacture, sales and marketing of high quality products exclusively for veterinarians worldwide. The Role The Senior Development Chemist significantly contributes to the successful & timely development of novel and generic pharmaceutical products, utilizing formulation technologies/methodologies to carry out required development activities. The Senior Development Chemist must be able to work independently across the scope of development activities i.e. from bench top development through to supporting regulatory requirements for successful submission and approval of filings. The Senior Development Chemist can be a member of international cross-functional and cross-site project teams and participates in design and execution of development projects. In addition, a key aspect of this role is the technical leadership, coaching and co-ordination of colleagues to help achieve their respective project and development goals. General Role Responsibilities: The following reflects management’s definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this role at any time due to reasonable accommodation or other reasons.Plans, develops, and implements scientifically well-designed experimental programs and demonstrates creativity and capability in pharmaceutical research and development.Independently designs, develops, optimizes and executes formulation laboratory experimentsTroubleshoots formulation issues that may occur during product development, validations, manufacturing processes, tech transfer/scale-up.Development and scale up of robust drug product formulations and manufacturing processes based upon quality by design (QBD) concepts that address critical quality attributes and process parameters. Processes must ensure quality, afford satisfactory yields and provide transferability to commercial manufacturing operations.Applies key API and/or formulation physicochemical data to support the development process and to identify the root cause of potential stability, manufacturing and performance issues e.g. pKa, pH, solubility, disintegration, dissolution, particle size, HPLC assay, related substances etc.Actively manages priorities and schedules experimental work etc. to meet or exceed project milestones. Regularly communicates project progress, challenges and potential delays to stakeholders.Responsible for maintaining their training curriculum in line with departmental and company-wide SOPs and GMP regulationsMeasures key API and/or formulation physicochemical data to support the development process and to identify the root cause of potential stability, manufacturing and performance issues e.g. pKa, pH, solubility, disintegration, dissolution, particle size, HPLC assay, related substances etc.Actively manages priorities and schedules experimental work etc to meet or exceed project milestones. Regularly communicates project progress, challenges and potential delays to stakeholders.Responsible for maintaining their training curriculum in line with departmental and company-wide SOPs and GMP regulations.Manages relationships and output of internal and/or contract labs that may be carrying out various development activities on company’s behalf.Provide technical guidance in formulation development to less experienced colleagues.Assists in the preparation of Chemistry, Manufacturing and Control (CMC) documents for Regulatory submission.Independently authors and reviews technical documents, such as protocols, technical reports, batch records, test methods, and operating procedures.Accurately and contemporaneously records experimental procedures, test results and observations, and reviews data to meet corporate, regulatory and GMP requirements.Actively managing working relationships through engagement with cross-functional and cross-site teams in the design and execution of studies e.g. technical services/manufacturing, clinical, regulatory, QA/QC etc.Timely monitoring and evaluation of release and stability data for GMP compliance, out of specifications, out of trend, and method performance issues, conduct and co-ordinate investigations and recommend corrective and preventative actions as needed.As applicable, arranges/performs Preventative Maintenance (PM) and Performance Qualification (PQ) for equipment for which they are responsible.Adheres to departmental and requirements for EH&SAdheres to SOP and GMP requirements.Reports project progress against technical and project objectives to Product Development, CMC (CMC leads) and Pharmaceutical Development Manager (functional line management). Key Performance Indicators:Project and associated tasks are delivered per agreed timelines.Projects are executed in compliance with Regulatory and Compliance (GMP and EH&S) requirements.General processes such as project planning, quality processes, project planning, risk management and site strategy are included in the work. Competencies Compliance and Safety Engagement Good manufacturing Practices Problem Solving Project Management Communication Results Focused Relationship Management (Internal and External) Product Lifecycle Product and Technical Knowledge Related Analytical Methodologies Regional Regulatory Knowledge Takes ownership Team player Skills: Self-motivated, driven and resourceful Highly organized Demonstrated ability in planning and priority setting Excellent problem solving and decision-making Meticulous attention to detail Versatility and flexibility Ability to work autonomously on multiple concurrent projects Ability to work effectively as a member of a team Demonstrated success in working in a cross-functional team environment Creativity and initiative e.g. in resolving problems Results focused (sense of urgency) Qualifications: Bachelor’s, Master’s Degree, PhD in a relevant field e.g. Chemistry, Pharmaceutical Sciences A proven track record e.g. ca. 5+ years’ experience in successful formulation development in a variety of pharmaceutical dosage forms Knowledge and Experience: Extensive experience in formulation development of a variety of dosage forms, with strong evidence of ability to design and implement experiments Good working knowledge of physical and chemical techniques used to characterise raw materials and finished products. Good knowledge of regulatory requirements, including FDA, EMEA, VICH/ICH regulations Demonstrated project and technical leadership experience Strong verbal and written communication in English
Deadline: 26-07-2024
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