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Job Description

Seeking a highly motivated, experienced Bioanalytical; 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.

"With an average of 20 years of experience, our scientific leadership team has successfully delivered over 100 early phase and 19 commercialized products for global pharmaceutical companies. We have served over 1,000 clients, supporting more than 2,000 new chemical entities.

Leveraging our unique expertise, we collaborate with you to design and develop the most suitable crystal form and formulation for further development. Our guiding principle of "getting the crystal form and formulation right the first time for Phase I" not only expedites the progression of your molecule to IND filing and Phase I clinical trials, but also minimizes the necessity for human PK bridging studies. This approach saves valuable time and reduces costs as your program moves forward to Phase II or subsequent clinical trials."

Role and Responsibilities

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

• Present/interpret data internally and/or externally as needed.

• Participate in interactions with clients and ensure overall customer satisfaction.

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

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

• Assist with the oversight of the laboratory and mentor junior staff.

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

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

• Ensure and reviews lab maintenance activities and maintains a clean and safe lab environment

• Develop, write, and review protocols and SOPs.

• Participate in regulatory compliance activities

Qualifications

• Ph.D. (preferred), Master’s, or Bachelor’s degree in biology, immunology, chemistry, pharmacology, or other related scientific fields required.

• Requires a minimum 5 years of relevant experience in a CRO or drug-development environment.

• MUST have LCMS experience specifically with Large Molecules

• Ability to work independently and have good attention to details.

• Good knowledge of regulated bioanalysis. GLP/GCLP experience preferred.

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

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

• Effective written and verbal communication skills.

• Experienced 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.