Scientist I

Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you

As a Scientist 1, focus mass spectrometry, you will oversee and coordinate all aspects of laboratory work, preparation of driving documents (Bioplans and Validation Plans), instructions to the Analysts assigned to projects, for the conduct of the bioanalytical portion of GLP non-clinical and regulated clinical studies.

**Essential Functions**:
Serve as a client contact for bioanalytical method validations and the bioanalytical phase of clinical and nonclinical studies as a Bioanalytical Principal Investigator.
Work with multiple internal and external stakeholders.
- Review protocol and assure study is conducted in accordance with Protocol
- Provide technical contributions to nonclinical protocol/study plan and work with Study Directors as per the multisite guidance
- Write and approve Bioanalytical, Validation Plans
- Responsible for experimental data generated on assigned study
- Assure corrective action is taken and documented when necessary
- Review and approve all project-related QA audits
- Responsible for study documentation
- Assure all study personnel have adequate training, education and experience to perform required study functions
- Additional responsibilities as outlined in SOPs

**Job Requirements**:

- Minimum of a Bachelors degree or equivalent in a science-related field with 2 or more years of industry experience preferred
- 2 or more years previous laboratory and/or GLP knowledge preferred; having experience as a bench Analyst in a regulated environment experienced in mass spectrometry analysis
- Proficiency with computers
- Excellent oral and written skills

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences