Director CMC Operations
Abarca HealthSalary not specified
- Full Time
- Senior (5 to 8 years)
Not SpecifiedCompensation
Entry Level & New GradExperience Level
Full TimeJob Type
UnknownVisa
BiotechnologyIndustries
Requirements
Candidates should possess a high school diploma or equivalent, and a Bachelor’s degree or Biotech certificate is preferred. They must have solid interpersonal and teamwork skills, the ability to work cross-functionally, and the willingness to learn and advance within the company and/or department. Flexibility to work necessary production and/or maintenance hours is required, along with the ability to lift up to 50 lbs. with assistance and work in a cleanroom environment for extended periods of time.
Responsibilities
The Manufacturing Associate is responsible for adhering to all Standard Operating Procedures (SOPs), Master Production Records (MPRs), protocols, policies, regulatory requirements, good manufacturing practices (GMPs), and safety guidelines. They participate in and/or lead unit operations, setup and maintain cGMP equipment, ensure compliance with quality systems and safety procedures, and proactively work with team members to achieve training competency. The role also includes reviewing executed batch production records, operating analytical equipment, mixing and storing chemical solutions, and maintaining manufacturing environmental conditions, while effectively collaborating with cross-functional partners such as Quality Assurance, Quality Control, Supply Chain, and Facilities.
Skills
Standard Operating Procedures (SOPs)
Master Production Records (MPRs)
cGMP
GMP
Batch Production Records
Analytical Equipment
Mixing
Chemical Solutions
Environmental Conditions
AGC Biologics
Contract development and manufacturing for biopharmaceuticals
About AGC Biologics
AGC Biologics specializes in the development and manufacturing of therapeutic proteins, plasmid DNA, viral vectors, and genetically engineered cells for the biopharmaceutical industry. The company provides end-to-end solutions, assisting clients from the initial development stages to full-scale production. Their services are particularly focused on fast-tracking projects for orphan drugs and rare diseases, which often require quicker timelines. AGC Biologics operates a network of advanced facilities across the U.S., Europe, and Asia, all adhering to strict quality regulations known as current Good Manufacturing Practices (cGMP). What sets AGC Biologics apart from competitors is its commitment to continuous innovation and its recent expansion to enhance capabilities in cell and gene therapy. The company's goal is to support biopharmaceutical companies in bringing new treatments to market efficiently and effectively.
Key Metrics
Bothell, WashingtonHeadquarters
2001Year Founded
$613MTotal Funding
ACQUISITIONCompany Stage
Biotechnology, HealthcareIndustries
1,001-5,000Employees