Staff Engineer, Synthetic and Bioconjugation Scale-Up Technologies (PMPD)
Regeneron
5 hours ago
On-site
Tarrytown, NY
Operations
Responsibilities:
- Provide scientific leadership and support for synthetic oligonucleotide process development using Quality by Design (QbD), process scale-up, and technology transfer.
- Design and develop scalable, robust, controlled GMP-ready processes for chemical synthesis (including purification development and analytical characterization techniques).
- Ensure compliance with lab and environmental safety expectations and applicable regulatory requirements.
- Collaborate with R&D Chemistry, Formulations Development, Analytical Chemistry, Protein Biochemistry, CDMOs, and other stakeholders to ensure integrated program success.
- Generate robust technology transfer documentation and support production onsite during scale-up/GMP manufacturing.
- Partner with External Manufacturing/IOPS teams to vet CDMOs and successfully transfer processes with immediate, first-time success.
- Develop new technologies for process improvements, predictive process models, and novel at-line/in-line process analytical technologies.
- Review and provide domain expertise for regulatory submissions.
- Author publications, reports, technology transfer documents, regulatory support documents, and patents.
- Perform long-term planning for laboratory personnel, supplies, and equipment.
- Travel up to 20%.
Qualifications:
- Ph.D. or Master’s in organic chemistry or related field.
- Industrial experience: 3–6+ years post-PhD OR 10+ years post-MS OR 15+ years (BS) in API process development (preferred).
- Highly preferable: experience with small-molecules in the bioconjugates space.
- Preferred: hands-on organic/oligonucleotide synthesis and characterization (MS, NMR, IR, HPLC) and purification (crystallization, extraction, chromatography).
- Preferred: experience with solid-phase and liquid phase peptide/oligonucleotide synthesis.
- Plus: proven experience scaling-up synthetic oligonucleotide syntheses and technology transfer to a GMP manufacturing facility.
- Well-versed with ICH/regulatory guidelines and their impact on process development.
- Plus: experience with multi-functional Chemistry, Manufacturing and Control (CMC) teams.
Required/Preferred Skills:
- Process development/technology transfer; GMP-ready process design.
- Analytical characterization and purification expertise.
- Scientific communication and problem-solving.
Benefits:
- Salary range (annually): $128,600.00 - $210,000.00
Application instructions:
- Apply now.
- Provide scientific leadership and support for synthetic oligonucleotide process development using Quality by Design (QbD), process scale-up, and technology transfer.
- Design and develop scalable, robust, controlled GMP-ready processes for chemical synthesis (including purification development and analytical characterization techniques).
- Ensure compliance with lab and environmental safety expectations and applicable regulatory requirements.
- Collaborate with R&D Chemistry, Formulations Development, Analytical Chemistry, Protein Biochemistry, CDMOs, and other stakeholders to ensure integrated program success.
- Generate robust technology transfer documentation and support production onsite during scale-up/GMP manufacturing.
- Partner with External Manufacturing/IOPS teams to vet CDMOs and successfully transfer processes with immediate, first-time success.
- Develop new technologies for process improvements, predictive process models, and novel at-line/in-line process analytical technologies.
- Review and provide domain expertise for regulatory submissions.
- Author publications, reports, technology transfer documents, regulatory support documents, and patents.
- Perform long-term planning for laboratory personnel, supplies, and equipment.
- Travel up to 20%.
Qualifications:
- Ph.D. or Master’s in organic chemistry or related field.
- Industrial experience: 3–6+ years post-PhD OR 10+ years post-MS OR 15+ years (BS) in API process development (preferred).
- Highly preferable: experience with small-molecules in the bioconjugates space.
- Preferred: hands-on organic/oligonucleotide synthesis and characterization (MS, NMR, IR, HPLC) and purification (crystallization, extraction, chromatography).
- Preferred: experience with solid-phase and liquid phase peptide/oligonucleotide synthesis.
- Plus: proven experience scaling-up synthetic oligonucleotide syntheses and technology transfer to a GMP manufacturing facility.
- Well-versed with ICH/regulatory guidelines and their impact on process development.
- Plus: experience with multi-functional Chemistry, Manufacturing and Control (CMC) teams.
Required/Preferred Skills:
- Process development/technology transfer; GMP-ready process design.
- Analytical characterization and purification expertise.
- Scientific communication and problem-solving.
Benefits:
- Salary range (annually): $128,600.00 - $210,000.00
Application instructions:
- Apply now.