Requisition xxxx BR
Posting Title: Scientist I, Analytical Development
Location: Boston, MA
Department: Analytical Development
Classification: R&D/Science
Occupation Name:
Pharmaceutical Research
Required Travel: 10%
Required Education: PhD
Relocation: Yes
Vertex Pharmaceuticals Incorporated is a global
biotechnology company committed to the discovery and development of
breakthrough small molecule drugs for serious diseases. The Company’s strategy
is to commercialize its products both independently and in collaboration with
major pharmaceutical companies.
Position Overview:
Vertex is seeking a talented individual to join our
Analytical Development group in Boston, MA.
As a member of the Analytical Development team, this role will support
the drug development programs at Vertex through analytical method development,
validation and transfer efforts, with special emphasis on drug substance
support, drug product support or both. Expertise in laboratory techniques
commonly used in the analysis of pharmaceutical products, especially HPLC, is
required.
Key Responsibilities include but are not limited to:
- Develop methods to determine
potency, purity, and stability for drug substances and/or drug products
- Set drug substance and drug product
specifications with the understanding of clinical study design and CMC processes
- Justify and set retest period,
storage, and shipping conditions
- Understand drug substance and
drug product development to independently provide requisite analytical support
- Identify critical
in-process-control issues and develop appropriate IPC methods
- Design stability studies for
drug substance and drug product
- Design validation protocols
that are appropriate for validating methods for their intended use.
- Present to cross functional
teams and effectively communicate critical analytical issues and solutions
- Develop and review source
documents for regulatory submissions
Basic Qualifications
- A Ph.D. degree in the life or physical sciences with a
preference for a concentration in Chemistry, Analytical Chemistry or
Pharmaceutical Chemistry
- Minimum Experience: 0 - 3 years current and relevant
industry experience working in drug substance and drug product support
- Understanding of the drug development process, including chemical
development and formulation development, is essential
- Good understanding of ICH and FDA method validation
guidelines are essential. The ability of
to understand the guidelines in context of development phase is preferred.
- Good understanding of GMP and hands-on GMP experience as
well as how to develop GMP friendly methods is preferred.
- Skilled in HPLC, GC, FT-IR, UV-VIS, KF, dissolution and
other instruments is essential. Strong
expertise in HPLC is preferred.
- The ability to work successfully in both a team/matrix
environment as well as independently is essential
- The ability to work in a fast pace environment, manage
priorities, and maintain timelines for multiple projects is essential
- Excellent written and verbal communication skills as
demonstrated by symposia presentations and research publications in peer
reviewed journals are essential
.jpg)
