Principal Process Chemist - Peptide Focus

Corden Pharma is a leading full‑service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines to improve people’s lives.

Provide strong technical leadership and documentation support for process development and GMP manufacturing of peptide products. Lead multi‑step syntheses from laboratory to full‑commercialization and support plant commercialization. Apply literature and theoretical concepts to design cost‑effective processes.

• Ensure chemistry meets cost, yield, throughput, and QSHE goals in GMP plant production.
• Apply complete knowledge of peptide development (SPPS, LPPS, Fragment Synthesis, crude, cyclization, purification, lyophilization, isolation).
• Lead large or multiple teams in matrix environment for peptide process development, transfer, or implementation at lab or GMP plant scale.
• Apply Quality by Design (QbD) principles – define QTPP, CQAs, CMAs, CPPs, perform risk assessments (FMEA, Ishikawa), design of experiments, multivariate analysis and follow relevant ICH guidelines (Q3A, Q3C, Q3B, Q3D, Q11, Q10, Q9, ICHM7).
• Develop and support scalable peptide processes and provide technical expertise during lab and GMP plant operations.
• Provide project data for budgeting of development, transfer, and implementation.
• Develop and execute procedures, processes, and methods to solve chemical and technical problems at lab or plant scale.
• Conduct research and development to improve manufacturing processes, costs, yield, and throughput.
• Act as a technical expert consulted by others within the organization.
• Collaborate closely with Analytical Development, Manufacturing, QA, Regulatory, and external partners.
• Provide expert input on timelines, risks, and mitigation strategies.
• Adhere to GDP and SOPs in all aspects of work.

Support a positive, healthy work environment and lead teams in development, troubleshooting, transfer, and improvement of chemical processes. Provide regular reports and solicit management feedback.

Perform all duties safely, applying knowledge, training, and experience.

Follow cGMP, FDA, ICH Q7, and other global regulations. Participate in developing and executing quality processes to deliver product quality objectives.

• Doctoral Degree (PhD) in Organic Chemistry/Biochemistry with strong expertise in peptide chemistry (SPPS, LPPS, Fragment Synthesis) and at least 5 years at a CDMO, or equivalent education and experience.
• Peptide experience required; track record of developing manufacturing processes suitable for >100 kg scale.
• Strong knowledge of multidisciplinary teams during tech transfer and experience with ICH, GMP, and regulatory CMC expectations.

Ability to write reports, proposals, contracts, and procedures; interpret scientific journals; present information and respond to questions.

Ability to calculate proportions, percentages, and perform basic algebraic and geometric conversions.

Apply logical and scientific thinking to complex problems.

Domestic and international travel required.

May require standing, walking, sitting, use of hands, reaching, lifting up to 50 lbs, basic vision, hearing, and other typical lab/plant physical requirements.

Exposure to fumes, airborne particles, low‑level chemicals, mechanical parts, weather, and moderate noise levels.

• Deep expertise in peptide synthesis technologies and optimization.
• Strong understanding of analytical methods for peptide characterization.
• Record‑keeping of laboratory and campaign reports.
• Experience in plant‑scale operations, scale‑up, and plant design.
• Knowledge of chemical reactivity, exotherms, side products, and waste streams.
• Proactive problem identification and resolution.
• Effective written and verbal communication.
• Statistical design of…