Job Description
About the position
- Responsibilities
- Executing drug product packaging and assembly activities.
- Support planning & organization (time, staff, lines, materials, equipment).
- Organize and lead team meetings.
- Supporting problem-solving sessions by serving as SME as needed.
- Divide work/tasks by providing clear guidance and instructions to the team.
- Drive continuous improvement with the team and act as coach for production activities.
- Collaborate with Line Owner and FLM on process/equipment investigations.
- Fill gaps in the production lines and support as required.
- Performing initial review of manufacturing batch records.
- Maintaining a safe environment while adhering to compliance standards and by identifying additional preventative measures.
- Crafting and/or revising standard procedures.
- Elevating critical and impactful events to management.
- Utilizing appropriate systems for job duties (SAP, MES, QMTS, and LIMS etc.).
- Provide SME support to Line Owners and NPI leads as needed.
- Initiating quality records and supporting triage.
- Assembly of a variety of combination products such as Auto Injectors and Automated Mini Dosers utilizing Semi-Automated Assembly Equipment.
- Bottling of small molecule tablets via manual process or automated processing.
- Assembly of vial sleeve and label and packaging of -70-degree C product.
- Requirements
- High school/GED + 2 years Manufacturing or military experience OR Associate's + 6 months Manufacturing or military experience OR Bachelor's.
- Nice-to-haves
- CFR and Regulatory knowledge.
- Mechanical ability.
- Knowledge of WIP lab equipment and computers.
- Basic statistical mathematical skills.
- Ability to interpret and apply GMP knowledge.
- Understanding of analytical methods for manufacturing area.
- Ability to understand and apply basic chemistry, biology and physical principles.
- Basic troubleshooting skills on Purification equipment.
- Excellent written and verbal communication skills with the ability to effectively communicate thoughts and ideas.
- Ability to prioritize tasks and work in a challenging and fast-paced work environment.
- Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models, including remote and hybrid work arrangements, where possible.
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