Responsible for participating in the following activities within the Drug Product Operations function:
- Assist the Drug Product Manufacturing team, the Drug Product Manufacturing Supervisor/Manager, subject matter expert(s), and quality teams to resolve deviations and track closures of any associated corrective actions.
- May assist with authoring, reviewing, and approving batch records, SOP’s and Work Instructions for both original and periodic updates.
- Assists manufacturing in preparing and driving the approval of material specification documents.
Equipment and Readiness Coordination
- Works with manufacturing to coordinate or execute water runs and/or aseptic process simulations.
- Works with validation to coordinate qualifications and re-qualifications associated with acquisition of new equipment.
- Assists in preparing User Requirement Specifications as needed for new equipment.
- Work with manufacturing lead in harmonizing best readiness practices between sites.
- Works with manufacturing and supply chain to follow-up on material ordering and receipt for GMP manufacturing.
- Originates and tracks manufacturing work orders as necessary.
Continuous Learning and Improvments
- Participate in team projects relating to Operational Excellence.
- Assists manufacturing lead and management to see what AAR lessons and room walk-through observations can be converted into guidebooks to establish and spread best practices to other functions within manufacturing.
- Participates in team projects relating to Operational Excellence such as Problem Analysis and Prevention.
- Assists team in creating guidebooks to proceduralize workflows within manufacturing and cross-functional flows and trains Manufacturing personnel on their use.
Right-First-Time (RFT) Execution
- Coordinates or may lead Pre-Run Readiness activities within manufacturing.
- Works with technical support personnel to gather post-execution data.
- Performs all other duties as assigned.
Required Skills & Abilities:
- Good oral and written communication skills, interpersonal and organizational skills.
- Practical understanding of equipment used in drug product operations
- Proficient with Microsoft Office applications
- Good self-discipline and attention to detail
- Must have flexible work hours – must be willing to work outside of normally scheduled hours as necessary; including opportunities for alternative shift hours and weekends as required.
- Experience working in cleanroom environments under sterile or aseptic conditions
- Must have good planning skills and must be willing to interface with and guide colleagues in many different roles and functions throughout the manufacturing facilities.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:
- Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate in a laboratory and/or manufacturing environment.
- Ability to lift up to 25 pounds; frequently, and up to 50 pounds; on occasion.
- Attendance is mandatory.
- Bachelor’s degree preferably in Science, Engineering, or other related field and with two (2) years’ experience preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain experience; OR
- Associate’s degree preferably in Science, Engineering, or other related field and with five (5) years’ experience preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain experience; OR
- High School Diploma and seven (7) years’ experience preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain experience
- Above experience must include one (1) year GMP experience.
- Experience working with aseptic filling operations
- Experience working with isolator technology
- Experience working with Vanrx SA25