Scientific Director Immunoassay (Malvern, PA)

Job Description

• 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.