ImmunityBio

ImmunityBio

Senior Scientist, Regulatory CMC

Summit, NJ · Senior

Sponsorship not specifiedDetected 1 day ago
FDA RegulatoryCommunicationOrganizational SkillsRegulatory Affairs

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Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

1 transfer filing in the last year, covering 1 worker. 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

  • Provide input and recommendations on CMC topics planned or performed.
  • Interact with other groups when needed to address CMC related matters.
  • Assist with the preparation of responses to Health Authority comments and questions pertaining to CMC issues.

Responsibilities

  • The Senior Scientist, Regulatory CMC will assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage the preparation of dossiers in eCTD format.
  • Support the development of global CMC regulatory strategies.
  • Support the design of CMC protocols.
  • Perform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
  • Prepare and review Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidances and company standards.
  • Assist with the preparation or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation.
  • May train others on Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications as appropriate.
  • Proficient in Electronic Document Management Systems
  • This desk-based role involves the close study of scientific and regulatory documents.

Requirements

  • Bachelor's Degree in life sciences or technical discipline with 6+ years' relevant progressive experience required
  • Master's Degree in life sciences or technical discipline with 4+ years' relevant progressive experience required
  • Doctorate degree in life sciences or technical discipline with 2+ years' relevant progressive experience required.
  • Experience in the preparation of the submission of CMC modules in eCTD format required
  • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
  • Knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins desired
  • Bachelor's Degree in life sciences or technical discipline with 6+ years' relevant progressive experience required; or
  • Master's Degree in life sciences or technical discipline with 4+ years' relevant progressive experience required; or

Skills

  • Knowledge, Skills, & Abilities
  • Strong organizational skills, written and oral communication skills, and attention to detail

Compensation

  • The annual base pay range for this position is below.

Benefits

  • Familiarity with organizing responses to Health Authority requests required
  • Familiarity with regulatory submissions outside of the US a bonus
  • Knowledge of Health Authority procedures and guidance regarding document management and electronic submission
  • Knowledge of Health Authority CMC guidance documents and requirements

Company info

  • At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace.

Visa & Work Authorization

  • race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law
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This listing is sourced directly from ImmunityBio's careers page and normalized into a canonical job model.