R&D Process Leader - API Development & Scale-Up

Siegfried; Athens (GA); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Flexible Spending

HSA Options

Life Insurance

PTO

401K

Job summary

Siegfried is seeking aSenior Process R&D Leader to drive development, optimization and transfer of manufacturing processes for APIs. The role requires guiding a team, ensuring regulatory compliance and coordinating technical transfer to Athens-based facilities or external manufacturers.

The ideal candidate will possess a Ph.D. with extensive process development experience, strong knowledge of cGMP, and expertise in HPLC, GC, NMR and related analytical methods.

Qualifications

• Ph.D. with 8+ years of related experience in an R&D laboratory or kilo lab/pilot plant.
• Experience supervising or managing others is preferred; GLP/cGMP and ICH knowledge are highly preferred.
• Expert knowledge of organic chemistry and cGMP regulations.

Responsibilities

• Lead the Process R&D group and ensure timely development and transfer of processes to production.
• Provide guidance and direction to department staff; manage performance and development.
• Oversee technical evaluations of customer proposals, safety, and regulatory filings for Athens labs and plant.
• Write and review protocols, reports, procedures, and regulatory documents.

Skills

Process R&D leadership

Regulatory compliance

Chemical process development

Education

Ph.D. in a related field

Tools

HPLC

GC

NMR

XRPD

Particle Size Analysis

Job description

Siegfried is seeking aSenior Process R&D Leader to drive development, optimization and transfer of manufacturing processes for APIs. The role requires guiding a team, ensuring regulatory compliance and coordinating technical transfer to Athens-based facilities or external manufacturers.

The ideal candidate will possess a Ph.D. with extensive process development experience, strong knowledge of cGMP, and expertise in HPLC, GC, NMR and related analytical methods.