Principal Scientist- Analytical Development Project Lead - Boston, MA, United States - Vertex Pharmaceuticals

Description

Job DescriptionAs a member of this dynamic and diverse CMC team focused on science and innovation, this position will provide the opportunity to collaborate across CMC functions and grow as a scientific and strategic leader in Analytical Development.

This role will be responsible for leading various aspects of small molecule Drug Substance and Drug Product development including oversight and accountability for all assigned analytical project deliverables.

Responsibilities may include, but are not be limited to, coordinating analytical method development and validation, coordinating stability studies, generating specifications, CDMO management, and contributing to the overall CMC analytical strategy for projects.

Key Responsibilities:

Leads analytical aspects of drug substance and drug product development for projects assigned, including designing, planning, and executing on IND and/or NDA-enabling analytical activities.

Leads laboratory staff and is responsible for the quality and accuracy of the work done by others.
Ensures that experiments are appropriately defined, developed, and conducted in compliance with applicable regulations and SOPs.
Performs technical data review, with overall accountability for all data generated in support of assigned deliverables.
Authors, reviews, and approves analytical methods, protocols, and reports.
Establishes specifications and retest/expiry to support clinical development.
Develops, reviews, and approves source documents for regulatory submissions.

Authors CMC sections of regulatory submissions and responds to information requests (IND, IMPD, NDA, MAA).Communicates routinely with all CMC functions and CMC leadership, including technical presentations.

Education and Experience:
Ph.

D., Master's, or Bachelor's in the Chemistry, Chemical Engineering, Pharmaceutical Chemistry, or life/physical sciencesMinimum of 5+ years (PhD), 7+ years (MS), 10+ (BS) experience supporting analytical activities within Pharmaceutical Development.

Previous technical project leader experience preferred.
Strong organizational, communication, leadership, and project management skills.
Strong skills in pharmaceutical analysis are required.

An in-depth knowledge of common analytical techniques used in the pharmaceutical industry, such as HPLC, GC, KF, dissolution, LC-MS and spectroscopy are required.

The ability to work successfully in both a team/matrix environment, as well as independently.
Knowledge of cGMPs and applicable Regulatory guidelines.
The ability to work in a fast-paced environment, manage priorities, and maintain timelines for assigned activities.

Demonstrated by symposia presentations and research publications in peer reviewed journals.#LI-OnsiteCompany InformationVertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at Boston, MAType:
Full time