Associate Director, API Tech Ops – Small Molecules

Biopharma Careers; Elkton (KY); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Benefits package

Job summary

Biopharma Careers is seeking an Associate Director, Technical Operations – Drug Substance for our Elkton, VA site in the United States. You will provide technical leadership across API manufacturing, tech transfer, validation, and lifecycle management to ensure safe, compliant production of active pharmaceutical ingredients.

The role drives continuous improvement, collaborates with cross-functional teams, and guides capital projects through startup to commercialization.

Qualifications

• Degree in Chemistry, Chemical Engineering, or related discipline.
• 10+ years API process development or manufacturing experience.
• Strong knowledge of cGMP and regulatory expectations.

Responsibilities

• Provide technical oversight for API manufacturing processes and tech transfer.
• Lead process scale-up, validation, and ongoing manufacturing support.
• Drive process improvements, yield, and impurity control.
• Ensure compliance with regulatory inspections and data integrity.

Skills

API process development

Process scale-up

cGMP manufacturing

Regulatory compliance

Cross-functional leadership

Problem solving

Data analysis

Education

Chemistry or Chemical Engineering degree

Tools

DeltaV

Electronic batch records

Job description

Biopharma Careers is seeking an Associate Director, Technical Operations – Drug Substance for our Elkton, VA site in the United States. You will provide technical leadership across API manufacturing, tech transfer, validation, and lifecycle management to ensure safe, compliant production of active pharmaceutical ingredients.

The role drives continuous improvement, collaborates with cross-functional teams, and guides capital projects through startup to commercialization.