Full Job Description
Job Description
Key Responsibilities
• Manage method transfers for small molecule drug product and drug product intermediate to various CMOs to support late-phase and commercial projects
• Author/review documentation to support new and existing commercial products (methods, SOPs, transfer protocols/reports, technical reports, etc.)
• Manage commercial QC testing at Vertex's Contract Testing Organizations
• Conduct technical review of analytical data (QC release and stability testing)
• Lead analytical OOS/OOT investigations and assist process investigations
• Perform statistical analysis for continued process verification
• Partner with MS&T, Supply Chain, Quality, and Regulatory to lead the coordination of activities in support of Vertex's commercial drug product and drug product intermediate manufacturing
• Manage analytical method lifecycle (method performance trending, process improvement, change control)
Knowledge and Skills:
• Experience in an analytical development or technical operations role, supporting new product development and/or commercialization
• Problem-solving/root cause analysis for analytical related issues
• Experience with chromatography methods such as HPLC, GC, and other common analytical techniques used in pharmaceutical analysis
• Experience with compendial methods for analysis (e.g. KF, elemental impurity testing, and identification by spectroscopy)
• Knowledge of cGMP's (e.g. Quality Control), ICH guidelines and associated CMC regulatory considerations in a pharmaceutical setting
• Proficient with data analytics and visualization tools
• Strong communication and technical writing skills
• The ability to work successfully in both a team/matrix environment as well as independently
• Demonstrated ability to effectively manage project(s), and flexibility to accommodate changes in responsibilities or project priorities
Education and Experience:
• Bachelor's, Master's, or PhD in Chemistry, Chemical Engineering, Pharmaceutical Chemistry, or other natural science
• Typically requires the following, or the equivalent combination of education and experience: PhD and 0-3 years, or Master's and 3+ years, or Bachelor's and 6+ years.
Pay Range:
$120,000 - $180,000
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:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: 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.
#LI-Hybrid