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Manufacturing Science & Technology Senior Principal Scientist

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Manufacturing Science & Technology Senior Principal Scientist

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General/Position Summary:
The Senior Principal Scientist/Particle Management (Manufacturing Science and Technology) will support the manufacturing network by applying a deep understanding of manufacturing controls for particle management, industry guidance for visual inspection of particles detected within cGMP pharmaceutical products, and final product quality. The role will have a proven track record of applying in-depth conceptual knowledge of engineering principles in particle management and experience with developing or improving process understanding related to tracking, trending and prevention of particles.

Job Description
General/Position Summary:
The Senior Principal Scientist/Particle Management (Manufacturing Science and Technology) will support the manufacturing network by applying a deep understanding of manufacturing controls for particle management, industry guidance for visual inspection of particles detected within cGMP pharmaceutical products, and final product quality. The role will have a proven track record of applying in-depth conceptual knowledge of engineering principles in particle management and experience with developing or improving process understanding related to tracking, trending and prevention of particles.
Key Duties & Responsibilities

Represent the MSAT function in cross-functional teams as a leader for particle control and ensure that the testing for particulate matter is conducted accurately and efficiently.

Manage established procedures and business processes to conduct final drug product visual inspection testing, support particle control program life cycle, and provide oversight of the training program (including particle libraries, VI training kits and operator qualification) at external suppliers.

Partner on the development of visual inspection solutions for challenges related to new and difficult to inspect cell and gene products.

Provide guidance and support of particle related deviations, OOS, investigation activities, and studies as subject matter expert.

Support regulatory agency requests, particle program related sections within filings, and proactive approaches to prepare sites with inspection related tools (i.e. storyboards, mock audits, walkthroughs, etc).

Maintain current with industry guidance and compliance expectations for particles in the pharmaceutical industry (i.e. USP & USP , USP

Develop and liaise with technical leads from other stakeholder programs and functions to build collective cell and gene therapy knowledge in support of particle life cycle management.

Support the development of programs /initiatives related to the trend reporting of particles (i.e. data entry systems, escalation paths, dashboards, etc.)

Utilize expertise in particle control engineering to develop innovative solutions and strategies for the company as the industry evolves with the advancement of therapeutic medicinal products.

Represent company at industry collaboration forums (e.g. Biophorum), pharmaceutical conferences and events and build relationships with business partners.

Continuously monitor and analyze manufacturing data trends and industry developments related to particle management and make recommendations for the company’s future goals and/or initiatives.

Collaborate with program and risk management functions to articulate technical risks within the particle control program and develop/manage mitigations as needed.

Required Education Level

• Advanced degree (MS/Ph.D/Eng Doc) in Science/Engineering or equivalent is essential
  

Required Experience

• Requires 6-8 years with a PhD of relevant experience in the biopharmaceutical industry, minimum of 9 years with a M.S., minimum of 11 years with B.S. or equivalent combination of education and experience of particle control and/or visual inspection related programs
  

Required Knowledge/Skills

• Previous experience working in a highly matrixed environment
• Extensive experience with biological process development and cGMP manufacturing.
• Experience with cGMP regulation/guidance and regulatory agency inspections
• Experience authoring/reviewing CMC product submissions and post-approval changes
• Experience working with continuous improvement, proficiency with operational excellence preferred
• Experience working with external manufacturing partners (CDMOs), suppliers, and service providers
• Ability to travel, nationally and internationally, up to 10%
• Flexibility to work on site a minimum of 3 days per week (Hybrid)
  

Pay Range
$0 - $0
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:

• Hybrid: work remotely up to two days per week; or select
• 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.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 E-Verify 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

Seniority level

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  Mid-Senior level

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  Full-time

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