Manufacturing Science and Technology Senior Scientist Downstream Biologics
Manufacturing Science and Technology Senior Scientist Downstream Biologics
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Job Description
Job Description
The Senior Scientist Manufacturing Science and Technology (MSAT) Downstream Biologics is a key role within the Commercial Manufacturing and Supply Chain (CMSC) organization and will be responsible for supporting technical programs within the Vertex Biopharmaceutical Sciences and Manufacturing Operations BSMO network. The role based at the Boston Seaport site will partner with crossfunctional teams internally and with external partners to ensure project deliverables supporting product commercialization are met and clinical and commercial supply to our patients is uninterrupted.The Senior Scientist is responsible for product commercialization activities (PPQ PLI readiness etc. postapproval process monitoring (CPV OOS OOT and Deviation handling) and change management.
Key Responsibilities:
Develops timelines and communicates with key stakeholders to ensure MSAT activities are prioritized and executed to meet project requirements.
Contributes to crossfunctional teams to ensure that projects are appropriately managed and are on target.
Resolves issues independently and escalates other risks appropriately as needed.
Partner effectively and manage relationships with external stakeholders and key suppliers to meet goals.
Through the development of process data driven reports support compliance and improvement related projects for downstream manufacturing operations.
Works towards the goal of continuous improvement to increase value and efficiency.
Provide support and applicable manufacturing process related content for regulatory submissions and assist with technical regulatory/agency questions.
Flexibility to work on site a minimum of 3 days per week with 10 travel expected.
Required Experience:
Requires a minimum 6 years of relevant experience in the biopharmaceutical industry or the equivalent combination of education and experience.
Bachelors degree in science/engineering or equivalent is essential.
Experience with process development and technical support of latestage and commercial biological products and cGMP manufacturing with a focus on downstream (purification) manufacturing operations.
Knowledge of cGMP regulations/guidance across major health authority regions.
Experience with technology transfer process validation and process monitoring.
Direct experience working with contract manufacturing organizations and/or technical service partners
Technical experience supporting manufacturing quality compliance including deviations change controls and CAPAs.
Pay Range:
$117400 $176100Disclosure 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 jobrelated factors permitted by law.
At Vertex our Total Rewards offerings also include inclusive marketleading 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 weeklong 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:
HybridEligible Or OnSite EligibleFlex Eligibility Status:
In this HybridEligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. OnSite: work five days per week onsite with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons 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 EVerify 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
Required Experience:
Senior IC
Employment Type
Full-Time
