Technical Lead

4 days ago

Newry Co Down, United Kingdom Norbrook Full time
Job ref: TLA101024 Job type: Permanent Location: Newry Closing date: Friday 25 Oct 2024 17:00 To lead and provide technical support to the pharmaceutical development team in relation to the design, execution and reporting of reverse engineering studies for new products in accordance with current guidelines.

Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.

This is a lab-based role and is expected to be a subject matter expert in analytical method development/validation and be aware of all current guidelines within this field in specific EMA and FDA guidelines.

Working in a diverse team of scientists developing a wide range of Pharmaceutical Dosage Forms including but not limited to, oral tablets, suspensions and solutions, sterile injectable suspensions and solutions, topical suspensions and solutions, and intra-mammary preparations.

Ensure that all work is carried out in accordance with the Company's Procedures and H&S requirements.

Main Activities/Tasks Lead the design and execution of reverse engineering studies to support the development process for pharmaceutical equivalence projects Develop and validate analytical methods, where required, to support reverse engineering studies in accordance with the relevant guidelines Lead and support the development and validation of dissolution studies within the department.

Provide technical support to the pharmaceutical development team to aid in troubleshooting of analytical methods.

Compile and review protocols and reports in line with both industry standard and company procedures.

Support the preparation of documentation and responses to regulatory submissions and queries Maintain an awareness of current guidelines in UK/Ireland, EU, US and ROW in relation to industry best practice for reverse engineering studies, dissolution studies, method development and validation, and where appropriate cascade training to the pharmaceutical development team for changing trends.

Lead/participate in project meetings as required.

Provide technical input and evaluation for the establishment of specifications for new products Identify and implement continuous improvements within the pharmaceutical development department Ensure all equipment is adequately maintained and to carry out qualification, cleaning and calibration of equipment as required.

Ensure compliance with EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations Any other duties as deemed necessary by Management Essential Criteria: Bachelor's Degree in a chemistry, analytical or pharmacy related discipline At least 5 years relevant, post graduate qualification, experience in a pharmaceutical development role.

Extensive experience in the development and validation of methods for APIs and excipients in finished products using a wide range of techniques UPLC, GC, size exclusion chromatography as well as wet chemistry Expertise in dissolution method development/application.

Experience in the field of Reverse Engineering Excellent computer skills including Microsoft Office suite in particular ability to trend data using an appropriate statistical package e.g.

Minitab, Excel Enthusiastic and hard-working individual, highly motivated to achieve technical targets with an ability to multitask Strong problem solving and troubleshooting skills .

Strong communication skills with a demonstrable record of working as a team and cross-functionally Desirable Criteria: Masters or PhD in Chemistry, pharmaceutical sciences Working knowledge of GMP and (V)ICH requirements Knowledge/Experience of Mass spectrophotometry, NMR, Experience of supporting ANDA regulatory submission Ability to critically review scientific literature.

Excellent report writing and presentation skills Working knowledge of Quality by Design principles To Apply Please forward your CV via the APPLY Now button below.

  • Technical Lead

    5 days ago

    Newry, Co. Down, United Kingdom Norbrook Full time

    Job Title: Technical LeadWe are seeking a highly skilled Technical Lead to join our Pharmaceutical Development team at Norbrook. As a Technical Lead, you will be responsible for leading and providing technical support to the team in relation to the design, execution, and reporting of reverse engineering studies for new products.Key Responsibilities:Lead the...

  • Technical Lead

    5 days ago

    Newry, Co. Down, United Kingdom Norbrook Full time

    Job Title: Technical LeadWe are seeking a highly skilled Technical Lead to join our Pharmaceutical Development team at Norbrook. As a Technical Lead, you will be responsible for leading and providing technical support to the team in relation to the design, execution, and reporting of reverse engineering studies for new products.Key Responsibilities:Lead the...

  • Technical Lead

    4 days ago

    Newry, Co. Down, United Kingdom Norbrook Full time

    Job Title: Technical LeadWe are seeking a highly skilled and experienced Technical Lead to join our Pharmaceutical Development team at Norbrook. As a Technical Lead, you will be responsible for leading and providing technical support to the team in relation to the design, execution, and reporting of reverse engineering studies for new products.Key...

  • Technical Lead

    4 days ago

    Newry, Co. Down, United Kingdom Norbrook Full time

    Job Title: Technical LeadWe are seeking a highly skilled and experienced Technical Lead to join our Pharmaceutical Development team at Norbrook. As a Technical Lead, you will be responsible for leading and providing technical support to the team in relation to the design, execution, and reporting of reverse engineering studies for new products.Key...

  • Technical Lead

    6 days ago

    Newry, Co. Down, United Kingdom Norbrook Full time

    Permanent Location: Friday 25 Oct 2024 17:00 To lead and provide technical support to the pharmaceutical development team in relation to the design, execution and reporting of reverse engineering studies for new products in accordance with current guidelines. This is a lab-based role and is expected to be a subject matter expert in analytical method...

  • Technical Lead

    6 days ago

    Newry, United Kingdom Norbrook Full time

    Job Title: Technical LeadWe are seeking a highly skilled and experienced Technical Lead to join our Pharmaceutical Development team at Norbrook. As a Technical Lead, you will be responsible for leading and providing technical support to the team in relation to the design, execution, and reporting of reverse engineering studies for new products.Key...

  • Technical Lead

    7 days ago

    Newry, United Kingdom Norbrook Full time

    Job Title: Technical LeadWe are seeking a highly skilled and experienced Technical Lead to join our Pharmaceutical Development team at Norbrook. As a Technical Lead, you will be responsible for leading and providing technical support to the team in relation to the design, execution, and reporting of reverse engineering studies for new products.Key...

  • Technical Lead

    1 week ago

    Newry, United Kingdom Norbrook Full time

    Job Title: Technical LeadWe are seeking a highly skilled and experienced Technical Lead to join our Pharmaceutical Development team at Norbrook. As a key member of our team, you will be responsible for leading and providing technical support to our team of scientists in the design, execution, and reporting of reverse engineering studies for new products.Key...

  • Technical Lead

    1 week ago

    Newry, United Kingdom Norbrook Full time

    Job Title: Technical LeadWe are seeking a highly skilled and experienced Technical Lead to join our Pharmaceutical Development team at Norbrook. As a key member of our team, you will be responsible for leading and providing technical support to our team of scientists in the design, execution, and reporting of reverse engineering studies for new products.Key...

  • Technical Support Lead

    4 months ago

    Newry, United Kingdom Norbrook Laboratories Full time

    **Job Overview** Technical Support Leads are responsible for all aspects of manufacturing providing support for the overall consistent running of the manufacturing and filling areas. This support will include leading investigations to identify root cause and appropriate corrective actions and therefore meeting production output needs of the company. **Main...

  • Apprentice Technician

    2 days ago

    Newry, Co. Down, United Kingdom Royal National Lifeboat Institution (RNLI) Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Regional Technician to join our team at the Royal National Lifeboat Institution (RNLI). As a key member of our Regional Technical Team, you will be responsible for providing technical expertise and support to our Lifeboat Station Technicians, Lifeguards, and other technical staff.Key...

  • Apprentice Technician

    2 days ago

    Newry, Co. Down, United Kingdom Royal National Lifeboat Institution (RNLI) Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Regional Technician to join our team at the Royal National Lifeboat Institution (RNLI). As a key member of our Regional Technical Team, you will be responsible for providing technical expertise and support to our Lifeboat Station Technicians, Lifeguards, and other technical staff.Key...

  • Head of Manufacturing Sciences and Technology

    5 days ago

    Newry, Co. Down, United Kingdom Norbrook Full time

    Job OverviewThe Head of Manufacturing Sciences and Technology is responsible for leading all facets of Process Validation, Technology Transfer into manufacturing, GMP floor support and Continued Process Verification in accordance with current good manufacturing processes (cGMP), across a network of 5 sites.Main ResponsibilitiesMaintain a high-performing team...

  • Head of Manufacturing Sciences and Technology

    6 days ago

    Newry, Co. Down, United Kingdom Norbrook Full time

    Job OverviewThe Head of Manufacturing Sciences and Technology is responsible for leading all facets of Process Validation, Technology Transfer into manufacturing, GMP floor support and Continued Process Verification in accordance with current good manufacturing processes (cGMP), across a network of 5 sites.Main ResponsibilitiesMaintain a high-performing team...

  • Senior Regional Technician

    3 days ago

    Newry, Co. Down, United Kingdom Royal National Lifeboat Institution (RNLI) Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Regional Technician to join our team at the Royal National Lifeboat Institution (RNLI). As a Senior Regional Technician, you will be responsible for providing technical support and guidance to regional and station technicians, ensuring that all technical activity is conducted in accordance...

  • Senior Regional Technician

    4 days ago

    Newry, Co. Down, United Kingdom Royal National Lifeboat Institution (RNLI) Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Regional Technician to join our team at the Royal National Lifeboat Institution (RNLI). As a Senior Regional Technician, you will be responsible for providing technical support and guidance to regional and station technicians, ensuring that all technical activity is conducted in accordance...

  • Head of Manufacturing Sciences and Technology

    6 days ago

    Newry, Co. Down, United Kingdom VanRath Full time £100,000

    Job Title: Head of Manufacturing Sciences and TechnologyFantastic opportunity for an individual to become a key leader in our Pharmaceutical company's manufacturing operations.About the Role:This role is based in our Newry office and is a permanent position with a fully negotiable salary, bonus, and additional benefits.Responsibilities:Lead all facets of...

  • Head of Manufacturing Sciences and Technology

    6 days ago

    Newry, Co. Down, United Kingdom VanRath Full time £100,000

    Job Title: Head of Manufacturing Sciences and TechnologyFantastic opportunity for an individual to become a key leader in our Pharmaceutical company's manufacturing operations.About the Role:This role is based in our Newry office and is a permanent position with a fully negotiable salary, bonus, and additional benefits.Responsibilities:Lead all facets of...

  • Head of Manufacturing Sciences and Technology

    6 days ago

    Newry, Co. Down, United Kingdom Norbrook Full time

    Permanent Location: Thursday 17 Oct 2024 17:00 Job Overview The Head of Manufacturing Sciences and Technology (MST) is responsible for leading all facets of Process Validation, Technology Transfer into manufacturing, GMP floor support and Continued Process Verification in accordance with current good manufacturing processes (cGMP), across a network of 5...

  • Senior Regional Technician

    6 days ago

    Newry, Co. Down, United Kingdom Royal National Lifeboat Institution (RNLI) Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Regional Technician to join our team in Ireland. As a key member of our Regional Technical Team, you will be responsible for providing technical expertise and support to our Lifeboat Stations and operational areas.Key ResponsibilitiesProvide technical support and guidance to regional and...