Process Development Engineer
AntriaBio is a biopharmaceutical company that develops novel extended release therapies by combining proprietary formulation and manufacturing capabilities with well-known molecules to significantly improve standards of care. AntriaBio's lead product candidate is AB101, an injectable once-weekly basal insulin for type 1 and type 2 diabetes that addresses a $11 billion market where the current standard of care is a once-daily basal insulin injection.
Summary: Candidate will be responsible for developing well characterized processes and transferring the process from lab scale to clinical GMP manufacturing. Experience in sterile pharmaceutical engineering, lyophilization, protein purification, emulsification, biodegradable microspheres (PLGA) preferred. Fundamental knowledge of pharmaceutical mechanical and chemical processes to include handling of organic solvents, bulk liquid and powder transfer, sterilization, containment, automation, and aseptic filling processes preferred.
Candidate will have a firm grasp on cGMP production requirements and expectations. Bulk sterile manufacturing and parenteral pharmaceutical experience is highly desirable.
- Design and execute process development studies and experiments to understand and improve processes.
- Work with formulation team to develop manufacturing processes for new products and scale-up to increase batch size from laboratory to clinical scale.
- Supports/prepares protocols, batch records, reports, SOPs, user requirement specifications, laboratory notebook studies, and other controlled documents. Provides technical definition to standard operating procedures and batch records.
- Coordinate activities to support production of development and clinical batches.
- Train manufacturing personnel in technical manufacturing processes.
- Interface / coordinate / collaborate regularly with Formulation and Analytical Development, Regulatory, Facilities, Manufacturing, Validation, and Quality.
- Development of User Requirement Specifications for process equipment supporting cGMP manufacture of sterile bulk and aseptically filled pharmaceutical dosage forms.
- Ability to follow procedures (SOP’s, batch records, training materials) clearly and concisely.
- Equipment procurement, expediting, installation, startup and integration.
Experience and Required Skills:
- Knowledge of pharmaceutical process development, scale-up and validation.
- Ability to calculate based on known principles, to determine critical process attributes and parameters. (pump and tank design, fluid flow, powder flow, rates of reaction, recovery, filtration)
- Understanding of cGMP requirements.
- Mechanical aptitude and ability to operate equipment.
- Knowledge of aseptic manufacturing and sterile fill/finish operations and requirements.
- Excellent technical writing skills (batch records, protocols, etc.)
- Must be able to work in a fast-paced work environment, possess good time management skills, and exhibit personal responsibility.
- Effective communication skills.
- Ability to analyze complex problems and implement creative solutions.
- Ability to learn quickly.
- Ability to work independently with as well as cooperatively on a team.
- Ability to manage multiple projects and prioritize work.
- Positive attitude and willingness to perform labor-intensive work when necessary.
- Experience in a GMP manufacturing environment supporting the commissioning, qualification and validation of GMP process systems and equipment. Intimate knowledge and ability to produce P&IDs, PFDs, equipment specification.
- Automation and controls experience specifically focused on process equipment and/or skid operations. PLC, software development, testing, integration, commissioning and qualification desirable.
- Must be a motivated self-starter with a mechanical aptitude.
- Ability to work overtime or shift work as required.
BS/MS in Chemical Engineering preferred and 3 or more years’ pharmaceutical process development experience and experience in pharmaceutical GMP manufacturing environment.