Job Description
Job Description
As a member of the Analytical Development Drug Substance (DS) subject matter expert team this role will support DS process and control strategy development for synthetic small molecule DS programs. Specifically, the individual will help develop new test methods, characterize key samples from DS synthesis development, and leverage these data to collaboratively advance the manufacture of our broad portfolio of potential medicines.
Candidates with extensive hands-on experience with laboratory techniques commonly used in the analysis of small molecule drug substances, especially HPLC and GC, as well as a strong knowledge and understanding of organic chemistry principles, will be best equipped to succeed in this role.
Key Duties and Responsibilities:
- Develop, troubleshoots, and execute a broad range of test methods suitable to determine potency, purity, and stability for drug substances and their precursors.
- Participate in the planning of experiments and provides requisite analytical support to assigned projects with a high degree of reliability and independence.
- Performs initial data review of experimental results and interprets immediate outcomes and/or conclusions within established protocols.
- Tabulate and trend data and collaboratively propose options for impurity and process control.
- Maintains accurate records of experiments and results in an electronic laboratory notebook.
- Demonstrates the ability to present results in both oral and written reports.
- Complies with applicable SOPs.
- Performs other duties as assigned.
Knowledge and Skills
- Experience analyzing samples using HPLC, GC, FT-IR, UV-VIS, KF, and other instruments. Experience with method development for chiral and achiral HPLC is preferred.
- Knowledge of organic chemistry reaction mechanisms and their application to drug substance process development and analytical derivatizations is preferred
- Familiarity with ICH quality guidelines and their application to drug substance development is preferred
- The ability to conduct experiments independently following established methodology and procedures with minimal supervision is essential.
- The ability to work successfully in both a team/matrix environment as well as independently is essential.
- The ability to work in a fast-paced environment, manage priorities, and maintain timelines for multiple projects is essential.
Education and Experience:
- BS or MS (or equivalent degree) in life or physical sciences with a preference for a concentration in chemistry, analytical chemistry or pharmaceutical chemistry
- MS with 2+ years, or BS with 5+ years of relevant experience working in a pharmaceutical development analytical laboratory
Pay Range:
$85,700 - $128,500
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
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