Generate Biomedicines

Generate Biomedicines

Principal Scientist, Drug Substance Process Development & Manufacturing (mAB development focus)

Somerville, MA · Principal

Sponsorship not specified$160k-$224kDetected 122 days ago
Machine LearningData AnalysisA/B TestingSupply ChainProcess ImprovementRecruitingGMPAnimal StudiesLeadershipCommunicationWriting

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odds of building a lasting career here

56Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role72
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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Files H-1B transfers

2 transfer filings in the last year, covering 2 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

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About the role

  • We are seeking a Principal Scientist, DS Process Development & Manufacturing, to join our growing Drug Substance group at Generate:Biomedicines.
  • The position offers broad exposure across upstream and downstream operations, CDMO management, and quality systems.
  • Review and/or author GMP documentation including batch records, change controls, deviations and CAPAs

Responsibilities

  • This role will support monoclonal antibody (mAb) drug substance development with a strong MS&T focus, bridging process development, scale-up, tech transfer, and GMP manufacturing execution.
  • Support Drug Substance process development and manufacturing activities (e.g., upstream expression, purification, UF/DF, viral clearance)
  • Design and execute scale-up, process characterization, and PPQ-enabling studies
  • Own tech transfer and support GMP campaigns at CDMO (person-in-plant support as needed)
  • Partner cross-functionally across CMC, QA, Regulatory, and Supply Chain to drive program execution
  • Drive continuous process improvement and process robustness initiatives
  • At Generate Biomedicines, you'll work closely with cross-functional teams and external partners to support the delivery of high-quality Drug Substance for clinical programs.
  • You'll gain or broaden your exposure to late-stage CMC activities, collaborate with leading CDMOs, and play a key role in ensuring robust documentation and data integrity for products that matter to patients.

Requirements

  • PhD or MS in Chemical Engineering, Biochemistry, or related field with relevant industry experience in biologics manufacturing
  • 5-8 years of industry experience in Drug Substance process development and/or GMP manufacturing in a biotech/pharma setting
  • Strong attention to detail with the ability to analyze complex technical data
  • Experience working with CDMOs, supporting tech transfer, and regulatory submissions
  • Hands-on experience with GMP documentation (eg: executed Batch Records) and quality systems (deviations, change control, CAPA)

Nice to have

  • Familiarity of regulatory issues pertaining to the manufacture of biologics, process validation, QbD principles and industry trends
  • Experience supporting BLA/IND submissions.
  • Exposure to accelerated development environments for early to late-stage program transitions

Skills

  • Leverage AI-driven tools for knowledge management and data analysis to enable efficient and scalable CMC workflows
  • Excellent communication and strong technical writing skills

Compensation

  • The base salary range provided reflects our current estimate of what we anticipate paying for this position.
  • Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics.
  • In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
  • Per Year Salary Range
  • $160,000 - $224,000 USD

Company info

  • The Role: We are seeking a Principal Scientist, DS Process Development & Manufacturing, to join our growing Drug Substance group at Generate:Biomedicines.
  • Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities.
  • We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.
  • This is an opportunity to contribute to the development of innovative biologics at a company transforming medicine through Generative Biology™.

Visa & Work Authorization

  • al employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status
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This listing is sourced directly from Generate Biomedicines's careers page and normalized into a canonical job model.