Role Summary
The Senior Scientist is responsible for process development, technology transfer, and management of external CDMO activities to ensure robust and reliable GMP manufacturing processes for antibody oligonucleotide conjugates and intermediates.
Responsibilities
- Lead drug substance bioconjugation: process development, tech transfer, scale-up, and process characterization of oligonucleotide conjugates.
- Lead internal CMC Process Development through hands-on laboratory work.
- Manage external CDMOs for process development, optimization, and tech transfer to deliver milestones on schedule.
- Partner with Research to support bioconjugation development and enhance tech transfer.
- Serve as technical leader for the bioconjugation drug substance process in cross-functional CMC teams.
- Set objectives, prioritize work, and allocate resources to meet program goals.
- Select, qualify, and manage external CDMOs.
- Drive continuous improvement and resolve issues in a timely manner.
- Evaluate and implement emerging technologies to improve conjugation and optimize purification.
- Liaise to define compliant, defendable CMC strategies.
- Prepare technical source documents, publications, and oral presentations.
- Prepare/review CMC and product documentation for global regulatory submissions.
- Review/approve development and cGMP documentation (Tech Transfer, Process Characterization, MBRs, Campaign Summary Reports).
Requirements/Skills
- PhD (or equivalent) and 5+ years working with bioconjugates; deep knowledge of conjugation chemistries, preparative chromatography, and TFF.
- Biopharma CMC management and/or R&D experience (preferably clinical-stage biotech).
- Familiarity with oligonucleotides (e.g., morpholino, antisense, siRNA) desired.
- Hands-on analytical characterization experience (HPLC/UPLC, SEC, SDS-PAGE, ion exchange, UV/vis).
- CDMO oversight experience.
- Ability to problem-solve drug substance development issues.
- Strong understanding of biologics/small molecule manufacturing, analytical development, QC/QA, and regulatory functions.
- Self-directed; effective in complex, fast-paced environments.
- Excellent interpersonal, organizational, negotiation, and communication skills.
Onsite Requirement
- Based in Waltham, MA; onsite 4β5 days/week; no remote role.
Pay Range
- $147,000β$180,000 USD.