R&D Process Manager (Pharmaceutical)

Location: Athens, Georgia, United States; onsite laboratory and plant role. Requires national and international travel and availability for scheduled or emergency overtime.

Company

Global pharmaceutical CDMO developing and manufacturing APIs and finished dosage forms across 16 sites and three continents.

What you will do

• Lead the Process R&D function and oversee the overall performance of the Process R&D Group.
• Develop, improve, scale up, validate, and transfer chemical processes for commercial, developmental, and reference standards manufacturing.
• Evaluate technical feasibility, scope, timing, safety, and resource requirements for customer proposals and new product manufacturing.
• Plan, perform, and report laboratory studies supporting process development, validation, and regulatory filings.
• Develop methodologies and evaluate technologies that reduce costs and improve process efficiency.
• Provide technical support to Production, Process Engineering, Regulatory, Quality, EHS, and external customers; review and approve technical and regulatory documentation.

Requirements

• Ph.D. with at least 8 years of related experience in an R&D laboratory, kilo lab, or pilot plant, including API process development.
• Expert knowledge of organic chemistry, chemical process development, process scale-up, and transfer to commercial production.
• Knowledge of cGMP, GLP, ICH, FDA, EPA, OSHA, and DEA requirements.
• Experience with HPLC, GC, NMR, XRPD, particle size analysis, and interpretation of analytical data.
• Strong technical writing, presentation, problem-solving, mathematical, and scientific reasoning skills.
• Must be able to work onsite in Athens, Georgia, meet laboratory physical requirements, and qualify for respiratory protective equipment use.

Nice to have

• Prior experience supervising or managing employees.
• Commercial production experience.

Culture & Benefits

• Safety, quality, sustainability, and employee development are emphasized.
• Medical, dental, and vision insurance.
• Flexible Spending and HSA options.
• Life insurance, short- and long-term disability, and pet insurance.
• Generous paid time off, sick leave, holiday time off, and 401(k).