Associate Director (Remote) Jobs

The successful candidate will oversee the GMP manufacturing of drug products at contract development and manufacturing organizations (CDMOs) and author and review drug product sections for regulatory submissions. This individual should be a team player with excellent problem-solving and communication skills and should be able to adapt to a timeline-driven work environment.

Key responsibilities include managing drug product GMP manufacture and related activities at CDMOs, such as reviewing/approving batch records and other manufacturing documents, troubleshooting any issues, and serving as the point of contact for manufacturing activities. The successful candidate will also be responsible for authoring and reviewing drug product sections for regulatory submissions and may manage formulation and process development at CDMOs.

Requirements:

• Skilled in risk management, deviation and root-cause investigations, and CAPAs
• They should have hands-on experience working in a cleanroom environment and drug product manufacturing
• Familiar with the entire drug product manufacturing process, from thawing and compounding to visual inspection and labeling
• Desired skills include formulation development, lyophilization cycle development, drug product process characterization and validation, equipment validation, and cleaning validation
• International travel
• Experience writing CMC sections of IND and antibody-drug conjugate (ADC) manufacturing is highly preferred
• Experience with filtration systems, filling lines, filling isolators, and environmental monitoring is also required
• Experience in CDMO management and working closely with Quality Assurance and Clinical Supply Chain Management functions
• PhD/MS/BS in Biochemistry, Chemical Engineering, or a related field, with at least 12 years of experience in the biopharmaceutical industry