Department Overview:
The Manufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production, and small-scale fill/finish. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.
This position is an entry-level position in the Manufacturing team and is the starting point to acquiring the skills and training required for a cGMP biomanufacturing environment. The Technician is responsible for the manufacture of biopharmaceutical products within a clean room environment. The position is expected to follow detailed instructions and established procedures with frequent supervision.
- Accurately follows manufacturing Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMPs) and with a focus on “right first-time” execution.
- Documents all activities in accordance with Good Documentation Practices (GDPs) in BPRs, Forms, and other quality documentation.
- Recognizes deviations from the intended procedure and raises awareness through the Rapid Response process.
- Proactively identifies safety, quality, and efficiency improvements.
- Actively participates in the Catalent Way (Continuous Improvement Culture).
- May lead “Just Do It” (JDI) Continuous Improvement activities and implement CI projects.
- May coach more junior team members on basic execution activities and act as an “onboarding buddy” to bring new team members up to speed on culture and basic workplace expectations.
- Participates in daily shift huddles and may lead shift exchange activities.
- Performs general cleanroom housekeeping, including room and equipment cleaning, disposal of waste, and maintenance of 5S standards.
- Completes all training activities required to maintain quality compliance within expected milestones.
Biomanufacturing – Central Services
- Performs basic buffer preparation activities, including weighing raw materials for production.
Education/Experience:
Behavioral Requirements:
- Ability to see and hear and read and write clear English.
- Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary.
- Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time.
- Ability to cooperate with coworkers within an organized team environment or work alone.
- Detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines.
- Ability to put aside personal opinions and focus on business needs, department needs or group needs
Company Description
AlphaProTemps is specialized in providing "best-in-class" professional staff augmentation services. These recruiting directives include temporary labor, contract sourcing, professional & technical niches, vendor-on-site, and managed service programs.