Job Description

To meet the needs of business growth, we are seeking a highly motivated, experienced senior scientist to join our passionate team to partner with our clients for success. The successful candidate will be responsible for supervising a team of LC-MS scientist and providing bioanalytical supports for both pre-clinical and clinical projects and will report to the Laboratory Head.

We are a Translational & Clinical Pharmacology CRO providing global-standard services in quantitative clinical pharmacology, GLP/GCLP bioanalysis, clinical research, and regulatory filing to leading biopharmaceutical companies. Our clients include multinational pharmaceuticals and mid- and small-size biotech companies.

We specialize in bioanalysis (PK/PD/ADA), biomarkers, assay development & validation, and sample analysis. The team has successfully supported multiple non-GLP, GLP (nonclinical) and GCLP (clinical) projects.

Role and Responsibilities

•\tDevelop, validate, conduct, and troubleshoot regulated bioanalytical methods for the quantitation of biotherapeutics drugs and metabolites using triple quadrupole (QQQ) LC-MS

•\tPresent/interpret data internally and/or externally as needed.

•\tParticipate in interactions with clients and ensure overall customer satisfaction.

•\tInteracts with QA to ensure all audit findings are addressed in a timely fashion.

•\tAuthor and/or review key regulatory documents, laboratory data, and technical reports.

•\tAssist with the oversight of the laboratory and mentor junior staff.

•\tAssist in establishing and improving all policies, procedures and required SOP documentation.

•\tUnderstand and adhere to corporate standards regarding code of conduct, safety, and GLP/GCP/GDP compliance.

•\tEnsure and reviews lab maintenance activities and maintains a clean and safe lab environment

•\tDevelop, write, and review protocols and SOPs.

•\tParticipate in regulatory compliance activities

•\tPerform all other related duties as assigned

Additional Skills & Qualifications

•\tPh.D., Master’s, or Bachelor’s degree in biology, immunology, chemistry, pharmacology, or other related scientific fields required.

•\tRequires a minimum 4 years of relevant experience in a CRO or drug-development environment.

•\tAbility to work independently and have good attention to details.

•\tGood knowledge of regulated bioanalysis. GLP/GCLP experience preferred.

•\tAbility to achieve objectives/timelines through collaborative efforts with coworkers, managers, and clients.

•\tMust be goal-oriented, quality-conscientious, and client-focused.

•\tEffective written and verbal communication skills.

•\tExperienced with LCMS or tandem Mass-Spec method development and validation for PK and/or biomarker analysis.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.