Job title:
Bioanalytical Manager
Company
Norbrook Laboratories
Job description
Job Description:Responsible for leading the clinical laboratory to support the development of pharmaceutical products in our state-of-the-art facilities.
You will be responsible for overseeing the development, validation and application of bioanalytical methods to clinical and preclinical studies using techniques such as LC-MS/MS, HLPC/UPLC and other advanced bioanalytical tools used.
You will ensure that the laboratories operate in compliance with GLP (Good Laboratory Practice) and other regulatory requirements (e.g., FDA, EMA, VICH) and will contribute to the successful submission of regulatory filings.
Support development of new veterinary 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.Main Activities/Tasks
- Lead, mentor and manage the Bioanalytical Laboratory Team Leads.
- Allocate resources and manage workflow to ensure project timelines are met.
- Foster a collaborative and high-performance environment.
- Work on a diverse scope of projects and provide scientific, technical, operational and compliance expertise.
- Oversee the development and validation of bioanalytical methods (e.g., LC-MS/MS, HPLC, UPLC).
- Ensure methods comply with international regulatory standards and are fit for purpose in drug development.
- Provide expertise to troubleshoot and resolve complex technical and scientific issues related to bioanalytical methods.
- Plan and manage bioanalytical studies to support preclinical and clinical development.
- Coordinate sample analysis from biological matrices (e.g., blood, plasma, tissues) for pharmacokinetics (PK) and residue profiles.
- Ensure timely delivery of high-quality data to internal and external stakeholders.
- Ensure compliance with GLP (Good Laboratory Practice) and other relevant regulations.
- Oversee preparation of bioanalytical study reports and method validation reports for regulatory submissions (e.g., IND, NDA, BLA).
- Collaborate with internal departments such as Pharmaceutical Development, Regulatory Affairs, Project Management, Procurement and Quality Assurance to ensure successful integration of bioanalytical data into broader drug development programs.
- Engage with external vendors and CROs to manage outsourced bioanalytical studies.
- Identify and implement process improvements to enhance bioanalytical laboratory efficiency and quality.
Essential Criteria:
- Minimum of 7+ years (for PhD), 10+ years (for MSc), or 12+ years (for BSc) experience in bioanalytical method development and validation within the pharmaceutical/biotech industry.
- Experience with working on multiple projects with a strong cross functional component
- At least 5+ years of people management with proven track record to motivate the team to meet project deliverables and timelines
- Strong leadership and management experience in bioanalytical laboratories.
- In-depth knowledge and expertise of bioanalytical techniques, including LC-MS/MS, HPLC, UPLC and other methods.
- Experience with regulatory filings and knowledge of regulatory requirements (FDA, EMA, VICH).
- Applied knowledge and expertise with GLP regulations and associated international guidance for industry.
Desirable Criteria:
- Experience with automation and high-throughput bioanalytical techniques.
- Previous experience managing bioanalytical work outsourced to CROs.
- Familiarity with LIMS (Laboratory Information Management Systems).
Additional Information:
Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.
We regret that applications received after the closing date and time will not be accepted.
Expected salary
Location
Newry
Job date
Sat, 12 Oct 2024 05:51:31 GMT
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