Summary of job description:
The Senior Associate, Mechanical Packaging, Labeling & Serialization will be a part of a cohesive team responsible for the serialization of RPx products at Replimune's Framingham facility. The Senior Associate, Mechanical Packaging, Labeling & Serialization will support the Supply Chain team in the planning, preparation, execution and completion of various serialization processes in accordance with SOP's, Good Manufacturing Practices and Safety policies/procedures. This role will also provide technical improvements, processes, materials, systems, troubleshooting support and project leadership for the packaging, labeling equipment associated with packaging serialization. The Senior Associate, Mechanical Packaging, Labeling & Serialization will support day-to-day operations.
This position is based in our Framingham location and typically has a 5-day on-site expectation.
Key responsibilities:
• Serves as the subject matter expert (SME) for serialization packaging and shipping line
by supporting business system testing and validation activities
• Provides packaging engineering, equipment and component expertise to improve costs,
efficiencies and meets production targets with regards to serialization activities
• Partners with internal stakeholders to implement various DSCAA and country specific
requirements
• Develops and implements training metrics
• Manages the development and implementation of process improvements and technology
upgrades that help with minimizing costs and production issues
• Analysis of operations, workflows and packaging process to provide solutions to
maximize efficiency and reduce waste
• Knowledge sharing with manufacturing groups to incorporate ideas and resolutions for
end-to-end execution
• Prepare presentations and technical reports
• Practice safe work habits and adheres to safety procedures and guidelines
• Complete activities in strict accordance with Standard Operating Procedures
• Document production activities in electronic systems, batch records, logbooks, or forms.
• Follow operational procedures and both written and verbal instructions from the
manager/lead.
Other responsibilities:
• Other duties as assigned
Educational requirements:
• 2 to 4+ years of cGMP experience/ Biotech Certificate/ Associates Degree or biotech /
engineering bachelor's degree and 0 -2 years of experience.
• Demonstrated basic math skills and communication skills.
Experience and skill requirement:
• Experience with vendor management
• Problem solving skills - anticipates and resolves complex problems
• Ability to work independently and with minimal direction
• Ability to lift to 35 lbs. and move heavy objects.
• Ability to stand for greater than 3 hours.
• Identify and communicate process deviations to the manager.
• Keep all training up to date and retrain prior to the expiration date.
• Work with hazardous materials (e.g., Isopropyl Alcohol).
• Routinely and safely handle high-value products in various stages of packaging
completion.
• Use computer-based systems for timecards, e-mail, and inventory management.
• Other duties as assigned that are deemed relevant to the position.
• Ability to work in teams.
Salary Range
Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $103,500-$133,500. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate's unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.
At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.
