How you’ll spend your day
Essential Duties & Responsibilities (Manufacturing Associate):
• Limited use of scientific/technical principles, industry practices and concepts in biologics manufacturing
• General understanding of operational details and procedures within the specific discipline
• Deep understanding and capabilities of a subset of group operational activities
• Follows, executes and documents GMP operational activities.
• Work is directly supervised
• Contributes to the operational success through support functions with support: Trackwise Investigation, SOP updates, batch record review/authoring, etc.
• Contacts are primarily with team, immediate supervisor, and area director to exchange and clarify information
• Communicate well with supervisor and team members and other collaborators
• Be able to summarize and share operational updates and summaries
• Order, obtain, maintain, and weigh all raw materials required for manufacturing processes using SAP and other inventory systems
• Perform manual visual inspection for GMP drug product following standard procedures
Additional Responsibilities (Senior Manufacturing Associate):
• Frequent use of scientific/technical principles, industry practices and concepts in biologics manufacturing.
• Deep understanding of operational details and procedures within the specific discipline.
• Operational work is performed in as a team with the ability to lead specific operations.
• Works under general supervision. Follows established procedures. Additional independence in support activities should be seen. Coordinates with other functions as needed under supervision.
• Capable to complete electronic records (Trackwise, Gap Assessments, SOP’s, etc) as needed.
• Frequent contact with the team, project leaders, management and professional staff on goals, progress and issues.
• Good written and verbal communications and interpersonal skills
• Solid presentation skills
• Maintain all GMP required individual training records for manual visual inspection team
• Calculate required raw materials based on requests for manufacturing processess
Your experience and qualifications
Qualifications / Education Requirements:
• Communicate well with supervisor, team members and other collaborators.
• Be able to summarize and share operational updates and summaries.
• Good written and verbal communications and interpersonal skills.
• Solid presentation skills.
• Manufacturing Associate: BS/MS in applicable discipline or 3+ years of relevant industry experience.
• Senior Manufacturing Associate: BS/MS in applicable discipline and 3 years of relevant industry experience or 6+ years of relevant industry experience
