Manager II - LC/MS Bioanalytical

About This Role

Lead scientific and operational activities for preclinical, clinical, and product release studies, specializing in chromatographic assay development for various modalities in complex biological matrices using HPLC and LC/MS/MS.

Responsibilities

• Lead teams developing and validating bioanalytical assays for support of preclinical, clinical and product release studies
• Motivate team by inspiring employees to achieve goals and aligning employee goals with company strategy
• Work closely with clients to assure successful on time execution of assays, validation, and sample analysis under GxPs
• Prioritize tasks and manage schedules efficiently
• Meet regularly with lab management to ensure instrument resources and employees are utilized effectively
• Responsible for team performance and outcomes
• Lead teams through transitions and new initiatives
• Design and execute experiments efficiently and assign tasks appropriately to employees based on skills
• Anticipate and mitigate potential problems and handle disputes calmly and fairly
• Present data and posters
• Conduct group team meetings to understand employee’s input and concerns, give constructive and timely feedback, and implement 1:1 meetings
• Hire and build a knowledgeable and cooperative team by investing in professional growth, setting goals and evaluating results
• Identify new analytical techniques and technologies and lead their implementation
• Review analytical instrument and equipment calibration, qualification and maintenance records
• Perform statistical analysis
• Write and review reports and prepare SOPs
• Fulfill the role of Bioanalytical Project Manager (BPM)/Principal Investigator (PI) for all assigned clients and studies
• Lead regularly scheduled client meetings to ensure effective communication and manage client expectations
• Provide client satisfaction and great science
• Achieve corporate revenue targets

Requirements

• Ability to develop chromatographic assays for all modalities in complex biological matrices using HPLC or LC/MS/MS
• Ability to oversee regulated bioanalysis, tissue analysis, protein binding, CYP inhibition, CYP induction, CYP phenotyping or metabolite profiling/ID studies
• Experience writing and executing validation and sample analysis plans
• Experience reviewing and evaluating PK/TK data and ISR results
• Experience planning and executing cross-site validations for project transfers
• Proficient in the use of MS Excel and Word
• Demonstrated experience serving in a supervisor role and leading teams
• Knowledge and application of regulatory guidance to experimental planning and design
• Experience working in GxP environments and demonstrated knowledge of GxP regulations

Qualifications

• Bachelor’s degree in chemistry, biochemistry, biotechnology, or related field with not less than twelve (12) years’ experience; Master’s degree with not less than ten (10) years’ experience; or PhD with not less than eight (8) years’ experience
• 8+ years of experience in a scientific laboratory environment, with demonstrated experience in a supervisor role and leading teams

Skills

* Required skills

Benefits