Job Description
Key Duties and Responsibilities:
- Technical Support and Investigations:
- Act as the primary point of contact for technical support related to clinical run investigations.
- Troubleshoot technical issues, perform in-depth root cause analyses, and develop hypotheses to address challenges.
- Design and execute hypothesis-driven test protocols to identify and resolve technical issues.
- Prepare comprehensive technical reports summarizing findings, conclusions, and recommendations.
- Investigation Leadership:
- Lead and facilitate investigation meetings with cross-functional teams, including manufacturing, quality control, quality assurance, and analytical development.
- Collaborate with technical Subject Matter Experts (SMEs) to develop and implement effective investigation strategies.
- Drive timely resolution of technical issues to ensure the expedited release of drug products.
- Cross-Functional Communication and CAPA Implementation:
- Serve as a liaison between manufacturing, quality control, quality assurance, and analytical development teams to address and resolve quality events.
- Develop and implement Corrective and Preventive Actions (CAPA) to mitigate risks and prevent recurrence of issues.
- Ensure timely communication and alignment across all stakeholders to maintain compliance and operational efficiency.
- Data Management and Analysis:
- Oversee the management and analysis of analytical product characterization and method development datasets from clinical runs.
- Utilize electronic systems for sample and data management, ensuring accurate data trending and reporting.
- Flexibility and Commitment:
- Provide support for critical projects, including occasional weekend or late-night work, to meet organizational deadlines and ensure project success.
Knowledge and Skills:
- Technical Expertise:
- Proficiency in a wide range of analytical platforms used for product characterization and release assays, particularly in the cell and gene therapy space.
- Strong working knowledge of manufacturing and quality systems to support quality events, analytical investigations, and the development of corrective and preventive actions.
- Experience with electronic systems for sample and data management, as well as data trending and analysis.
- Skills and Competencies:
- Exceptional problem-solving abilities with a methodical and analytical approach to technical challenges.
- Strong cross-functional communication and collaboration skills to effectively engage with diverse teams.
- Proficiency in good documentation practices to ensure compliance with regulatory and quality standards.
Education and Experience:
- Ph.D. (or equivalent degree) and 2-5 years of relevant post-doctoral employment experience, or
- Masters Degree (or equivalent degree) and 5+ years of relevant employment experience, or
- Bachelors Degree (or equivalent degree) and 7+ years of relevant employment experience
Pay Range:
$122,400 - $183,600
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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