Vertex Pharmaceuticals

Vertex Pharmaceuticals

Principal Scientist, Separation Methods Expert, Analytical Science and Technology (AS&T), Vertex Pharmaceuticals

Boston, MA · Principal

Sponsorship not specified$138k-$208kDetected 5 hours ago
Data AnalysisStatisticsProduct ManagementRecruitingGMPCommunicationWriting

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odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role82
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

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Employer immigration record

from this employer's Department of Labor filings

Green-card filing pattern in this occupation

Context, not a finding about this posting: of this employer's 17 green-card filings in this occupation, 100% were for a worker who already held the job.

Green-card follow-through: 83%

Of 12 labor certifications old enough to have been used, 2 expired without the employer filing the next step. Median time from filing to decision: 515 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.

Files H-1B transfers

29 transfer filings in the last year, covering 29 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • The Analytical Science and Technology (AS&T) Principal Scientist, Separation Method Expert, will be responsible for providing scientific and technical expertise within and across functional areas for late-stage & commercial methods and vendor management.
  • Be accountable for the success of company and department projects/activities and ensure on-time deliverables to meet program commitments.
  • Review method trending data and prepare APQRs.

Responsibilities

  • Lead analytical method remediation, validation and transfer for separation methods used for late stage and commercial Biologics programs.
  • Lead and support troubleshooting and investigations for in-process, release and stability testing.
  • Own Quality events and analytical related activities (Change Controls, Impact Assessments, Change Actions) related to analytical methods & related activities.
  • Collaborate cross-functionally with internal stakeholders and external partners to support analytical readiness for worldwide commercialization and ongoing product lifecycle activities.
  • Author technical documents, such as method SOPs, method validation/transfer protocols and report, method bridging and risk assessments.
  • Work with CMO/CTO or external partners on work request, product characterization, and technology transfers.
  • S/He will manage the method life cycle, including method remediation, validation, transfer, troubleshooting and investigations for OOT/OOS, along with data trending analysis.
  • Additionally, the principal scientist will partner closely with all stakeholders, and with contract testing sites establishing partnerships to ensure compliance with cGMP and Quality Management systems for the global network to deliver our medicines to patients effectively.

Requirements

  • In-depth, hands-on experience in separation methods including chromatographic (with variety of separation and detection modes), electrophoretic (CE and IEF) separation or impurity methods for biologics is a must.
  • Demonstrated proficiency with regulatory requirements, USP, and ICH guidelines related to potency assays for registrational filings is required.
  • Experience in statistical analysis tools (e.g. JMP) and/or sufficient knowledge of statistical concepts required for data analysis and generating plots is desired.

Skills

  • Demonstrated expertise in analytical method development, validation, transfer and lifecycle management for protein-based biologics products.
  • Familiarity with the GMP, CLP, and regulatory guidance such as ICH, USP/EP/JP as applicable to analytical methods and commercial-stage CMC.
  • Familiar with analytical methods for biological products characterization including but not limited to peptide mapping and MS is a plus.
  • Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency.
  • Education and Experience:
  • PhD, Master's or Bachelor's in Biochemistry, Chemical engineering, or a related discipline.

Compensation

  • $138,400 - $207,600
  • 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.

Benefits

  • Typically requires the following, or the equivalent combination of education and experience: PhD and 5+ years, or Master's and 8+ years, or Bachelor's and 10+ years of relevant work experience.
  • Support regulatory submissions and responses to inquiries from health agencies for INDs and BLAs for Biologics as analytical method Subject Matter Expert (SME).

Company info

  • work remotely up to two days per week; or select
  • work five days per week on-site with ad hoc flexibility.
  • 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 ApplicationAssistance@vrtx.com
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