Resolian
Job Description
Interested in learning more about this job Scroll down and find out what skills, experience and educational qualifications are needed. Serve as the subject matter expert (SME) in various LBA and/or PCR technologies (e.g., ELISA, MSD, Gyrolab, Luminex, qPCR, RT-qPCR, ddPCR, etc.). Lead a team of Ph.D. and non-Ph.D. scientists in the development and validation of bioanalytical methods to support multiple biopharmaceutical programs (e.g., PK, immunogenicity, biomarkers). Troubleshoot and resolve routine scientific issues; provide expertise across platforms and methods, oversee ongoing method development and validation projects, and ensure methods are robust and fit-for-purpose. Review method development and validation data to ensure scientific rigor, quality, and regulatory compliance prior to sample analysis. Review and/or approve methods, study plans and reports as required. Analyze method performance data to identify and drive improvements. Communicate directly with clients, manage expectations, and provide support during client and regulatory audits. Prepare and present scientific abstracts, posters, and presentations. Collaborate with Business Development to assess client requests and advise on feasibility. Support Business Development efforts in nurturing existing client relationships and securing new opportunities. Evaluate, implement, and adapt emerging technologies where applicable. Provide strong leadership and promote collaboration within the team; manage performance and foster professional development of staff. Establish and monitor key performance indicators (KPIs) to identify areas for improvement. Work with senior leadership to define and execute strategies for business growth and success. Track departmental revenue and contribute to financial planning and budgeting. Set and align departmental objectives with broader organizational goals. Oversee resource allocation and capacity planning. Direct staff recruitment, onboarding, training, and career progression. Ensure compliance with regulatory requirements, data integrity standards, and adherence to applicable SOPs. Review and author standard operating procedures (SOPs). Lead and implement continuous process improvement initiatives. Perform other duties as assigned. Skills, Education & Qualifications Ph.D. degree in biology or related major, with 10+ years' of working experience in regulated bioanalysis in CRO, biopharmaceutical or biotechnology companies. Strong scientific knowledge of bioanalysis on PK, ADA/Nab and biomarker studies using LBA technologies. Knowledge of PCR and flowcytometry technology is a plus. Demonstrated experience and expertise in developing/validating/implementing bioanalytical methods for both pre-clinical and clinical programs of various biopharmaceutical modalities (e.g., mAb, BsAb, ADC, fusion protein, nucleic acid, CGT, etc.). Extensive knowledge and understanding of regulatory requirements, such as GLP, GDP, GCP, ICH, 21CFR Part 11 and so on. Excellent knowledge and understanding of the pharmaceutical industry. Extensive experience in managing/conducting studies to support projects. Excellent communication skills (writing and speaking). Extensive experience in LIMS and ELN Able to lead, mentor, inspire and develop scientific staff, and to set and lead strategies for growing a group. Able to guide trouble shooting for problematic projects (method development, validation and sample analysis) with the team. Able to develop and implement research strategies and align with organizational goals. Able to foster scientific excellence and build scientific reputation internally and externally. Ability to identify opportunities and respond quickly to client requests and expectations. Great leadership experience in both project and people management is required. Able to achieve objectives/timelines through collaborative efforts with coworkers, managers, and clients. Excellent communication, interpersonal, organizational, and multi-tasking skills.
Interested in learning more about this job Scroll down and find out what skills, experience and educational qualifications are needed. Serve as the subject matter expert (SME) in various LBA and/or PCR technologies (e.g., ELISA, MSD, Gyrolab, Luminex, qPCR, RT-qPCR, ddPCR, etc.). Lead a team of Ph.D. and non-Ph.D. scientists in the development and validation of bioanalytical methods to support multiple biopharmaceutical programs (e.g., PK, immunogenicity, biomarkers). Troubleshoot and resolve routine scientific issues; provide expertise across platforms and methods, oversee ongoing method development and validation projects, and ensure methods are robust and fit-for-purpose. Review method development and validation data to ensure scientific rigor, quality, and regulatory compliance prior to sample analysis. Review and/or approve methods, study plans and reports as required. Analyze method performance data to identify and drive improvements. Communicate directly with clients, manage expectations, and provide support during client and regulatory audits. Prepare and present scientific abstracts, posters, and presentations. Collaborate with Business Development to assess client requests and advise on feasibility. Support Business Development efforts in nurturing existing client relationships and securing new opportunities. Evaluate, implement, and adapt emerging technologies where applicable. Provide strong leadership and promote collaboration within the team; manage performance and foster professional development of staff. Establish and monitor key performance indicators (KPIs) to identify areas for improvement. Work with senior leadership to define and execute strategies for business growth and success. Track departmental revenue and contribute to financial planning and budgeting. Set and align departmental objectives with broader organizational goals. Oversee resource allocation and capacity planning. Direct staff recruitment, onboarding, training, and career progression. Ensure compliance with regulatory requirements, data integrity standards, and adherence to applicable SOPs. Review and author standard operating procedures (SOPs). Lead and implement continuous process improvement initiatives. Perform other duties as assigned. Skills, Education & Qualifications Ph.D. degree in biology or related major, with 10+ years' of working experience in regulated bioanalysis in CRO, biopharmaceutical or biotechnology companies. Strong scientific knowledge of bioanalysis on PK, ADA/Nab and biomarker studies using LBA technologies. Knowledge of PCR and flowcytometry technology is a plus. Demonstrated experience and expertise in developing/validating/implementing bioanalytical methods for both pre-clinical and clinical programs of various biopharmaceutical modalities (e.g., mAb, BsAb, ADC, fusion protein, nucleic acid, CGT, etc.). Extensive knowledge and understanding of regulatory requirements, such as GLP, GDP, GCP, ICH, 21CFR Part 11 and so on. Excellent knowledge and understanding of the pharmaceutical industry. Extensive experience in managing/conducting studies to support projects. Excellent communication skills (writing and speaking). Extensive experience in LIMS and ELN Able to lead, mentor, inspire and develop scientific staff, and to set and lead strategies for growing a group. Able to guide trouble shooting for problematic projects (method development, validation and sample analysis) with the team. Able to develop and implement research strategies and align with organizational goals. Able to foster scientific excellence and build scientific reputation internally and externally. Ability to identify opportunities and respond quickly to client requests and expectations. Great leadership experience in both project and people management is required. Able to achieve objectives/timelines through collaborative efforts with coworkers, managers, and clients. Excellent communication, interpersonal, organizational, and multi-tasking skills.