Framingham, Massachusetts, United States · On-site
$121k–$158k/yr
Overview Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend o…
Skills: Commercial Packaging, Serialization, Team Leadership, GMP Compliance, GDP Compliance
Springfield, Massachusetts, United States · On-site
$27/hr–$46/hr
QUALIFICATIONS: Associates of Science Medical Technologist - American Society for Clinical Pathology- required for MLS 1 Manager my consider underfilling as MLTI or MLTII SCHEDULE: 32 hours a week, 1st shift LOCATION: On…
Skills: Clinical Laboratory Testing, Medical Laboratory Technology, Specimen Processing, Laboratory Safety, Quality Control
Boston, Massachusetts, United States · On-site
$31/hr–$33/hr
Job Description The Process Dev Engineering Scientific Associate will support stem cell therapy process development, including performing stem cell culture media optimization studies, stem cell expansion and differentiat…
Skills: Stem Cell Culture, Aseptic Processing, Bioreactor Systems, Cryopreservation, Cell Banking
Agawam, Massachusetts, United States · On-site
$80k–$100k/yr
Overview, Responsibilities, Qualifications Now Hiring: Operations & Quality Compliance Manager (Food Manufacturing) 📍 Location: Agawam, MA 💵 Salary: $80,000-$100,000 Based on Experience 🗓️ Schedule: Full-Time| Monday–…
Skills: SOP Development, Process Compliance, Root Cause Analysis, Operational Improvement, Production Workflow Analysis
Cambridge, Massachusetts, United States · Hybrid
$154k–$243k/yr
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice an…
Skills: Brand Insights, Sales Force Analytics, Targeting, Segmentation, Promotional Effectiveness
Salem, Massachusetts, United States · On-site
$39/hr–$94/hr
Site: North Shore Medical Center, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As …
Skills: Patient Care, Nursing Process, Clinical Assessment, Care Planning, Patient Education
Northampton, Massachusetts, United States · On-site
$22/hr–$31/hr
Site: Cooley Dickinson Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a…
Skills: EKG Technology, Patient Rights, HIPAA Compliance, Interpersonal Skills, Written Communication
Pembroke, Massachusetts, United States · On-site
Location: Pembroke Pines, Florida Memorial laboratory professionals understand that every specimen and every report are informing diagnosis, treatment and care. We never lose sight of the patient and family who are on th…
Skills: Laboratory Testing, Specimen Handling, Quality Control, Blood Bank, Clinical Laboratory Procedures
Danvers, Massachusetts, United States · On-site
$137k–$150k/yr
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less in…
Skills: Algorithm Development, Systems Engineering, Embedded Software Integration, Design Reviews, Risk Analysis
Indianapolis, Indiana, United States · On-site
$91k–$169k/yr
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who …
Skills: Strategic Account Planning, Negotiation, Contracting, Problem Solving, Business Analysis
Boston, Massachusetts, United States · On-site
$35/hr–$42/hr
Job Description We are looking for a motivated and detail-oriented Manufacturing Operations Associate to support the production of clinical cell therapy products in a cGMP manufacturing environment. In this hands-on role…
Skills: Aseptic Processing, cGMP Standards, Batch Record Execution, Cleanroom Operations, Raw Material Preparation
Walpole, Massachusetts, United States · On-site
$26/hr–$36/hr
Job DetailsJob Location: Walpole, MA 02081Position Type: Full TimeSalary Range: $26.00 - $36.00 HourlyJob Shift: AnyTufts V.E.T.S. is a multispecialty emergency and critical care VECCS level 1 certified facility in New E…
Skills: Patient Assessment, Venipuncture, IV Catheter Placement, Medication Administration, Continuous Rate Infusions
Walpole, Massachusetts, United States · On-site
$26/hr–$36/hr
Job DetailsJob Location: Legal Address - Walpole, MA 02081Position Type: Full TimeSalary Range: $26.00 - $36.00 HourlyJob Shift: AnyTufts V.E.T.S. is a multispecialty emergency and critical care VECCS level 1 certified f…
Skills: Patient Assessment, Venipuncture, IV Catheter Placement, Medication Administration, Continuous Rate Infusions
Boston, Massachusetts, United States · On-site
$115k–$150k/yr
Overview Monte Rosa Therapeutics seeks an experienced, highly organized, and collaborative People Experience Operations (HR) Generalist to support and enhance our people operations function. This role will be responsible…
Skills: HR Operations, HRIS Administration, Employee Lifecycle Management, Employment Law Compliance, Workforce Analytics
Wilmington, Massachusetts, United States · On-site
$131k–$190k/yr
About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and…
Skills: Automated Test Equipment, Analog Circuit Design, Digital Circuit Design, C++, Visual Basic
Wilmington, Massachusetts, United States · On-site
$157k–$227k/yr
About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and…
Skills: Automated Test Equipment, Analog Circuit Design, Digital Circuit Design, C++, Visual Basic
Boston, Massachusetts, United States · On-site
$33/hr–$42/hr
POSITION SUMMARY: Assesses and coordinates medical nutrition therapy and nutrition education activities for patients. Plans and provides nutritional care to patients by interpreting and adapting physician prescribed diet…
Skills: Medical Nutrition Therapy, Nutrition Education, Enteral Nutrition, Parenteral Nutrition, Nutrition Focused Physical Exam
Orleans, Massachusetts, United States · On-site
Primary Location Location R Department Human Genetics Shift Day (United States of America) Schedule Full time Weekly Hours 40 FTE 1 Employee Status Regular The Genetics and Genomics Diagnostic Laboratory in the Division …
Skills: Laboratory Genetics and Genomics, Clinical Laboratory Management, Multiomic Testing, Rapid Genome Sequencing, Long-read Genome Sequencing
Framingham, Massachusetts, United States · On-site
$192k–$281k/yr
Internal Medicine Specialist – BluePearl Pet Hospital | Framingham, MA BluePearl Specialty + Emergency Pet Hospital in Framingham, Massachusetts is seeking a board-eligible or board-certified Internal Medicine clinician …
Skills: Internal Medicine, Veterinary Diagnostics, CT Imaging, Ultrasound, Digital Radiography
Boston, Massachusetts, United States · Hybrid
$260k–$310k/yr
The Senior Director, Medical Communications, will report to the Head of Medical Affairs. The individual will be accountable for Verastem’s external communications for both avutometinib + defactinib and pipeline assets (V…
Skills: Medical Communications Strategy, Publication Planning, Budget Management, Oncology, Stakeholder Management
Framingham, Massachusetts, United States • On-site
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Lead the commercial packaging and serialization team to ensure compliant and efficient product flow from packaging to shipment. Oversee the operational execution of serialization processes and maintain strict adherence to GMP and GDP requirements.
Requires a bachelor's degree in Supply Chain, Operations, or Life Sciences with over 5 years of experience in pharmaceutical packaging and serialization. Must have hands-on experience with Antares, TraceLink, and Oracle ERP within a regulated environment.
Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.
At Replimune, we live by our values:
People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.
The Manager, Commercial Packaging & Serialization is responsible for the end-to-end execution of commercial packaging and serialization operations performed at Replimune’s Framingham site, ensuring compliant, reliable, and efficient product flow from packaging through release and shipment to the 3PL.
This role provides direct leadership of the packaging and serialization team, overseeing batch execution, serialization activities, and shipment readiness in accordance with GMP and GDP requirements. The position serves as the operational owner of packaging and serialization processes, ensuring inspection readiness, data integrity, and alignment with supply plans.
The role requires strong hands-on experience with packaging line serialization equipment (e.g., Antares), serialization data platforms (e.g., TraceLink), and ERP systems (Oracle) to support effective execution, troubleshooting, and cross-functional coordination.
Team Leadership & Execution
· Lead, coach, and develop the commercial packaging and serialization team, driving accountability and high performance
· Establish daily/weekly priorities to ensure execution of commercial packaging schedules and shipment timelines
· Provide hands-on operational leadership, including issue escalation, troubleshooting, and decision-making
· Build team capability in GMP/GDP execution, documentation practices, and serialization operations
Packaging Operations
· Oversee execution of Replimune’s commercial packaging activities, ensuring alignment with production plans and inventory targets
· Ensure packaging operations are performed in accordance with approved batch records, SOPs, and quality requirements
· Monitor packaging performance (e.g., throughput, right-first-time, deviations) and drive continuous improvement
Serialization Operations
· Manage execution of serialization processes on packaging lines using Antares serialization equipment, including commissioning, aggregation, and reconciliation
· Ensure accurate and timely transfer of serialization data to enterprise systems and external stakeholders through TraceLink
· Monitor serialization performance and proactively resolve issues impacting line operations or data integrity
· Support investigation and resolution of serialization-related deviations, including data discrepancies and EPCIS exceptions
Shipment to 3PL
· Support operational activities required to prepare and transfer finished drug product from packaging through shipment to the 3PL
· Ensure all batch records, serialization data, and shipping documentation are complete and accurate prior to transfer
· Coordinate with Warehouse and Supply Chain teams to ensure on-time shipment execution
GDP, Compliance & Documentation
· Ensure strict adherence to GDP and GMP requirements across packaging and shipment processes
· Oversee execution and review of batch records, serialization documentation, and SOPs
· Ensure documentation accuracy, completeness, and audit readiness
· Partner with Quality to manage deviations, CAPAs, change controls, and inspections
· Maintain continuous inspection readiness across packaging and serialization operations
Packaging Line & Systems Oversight
· Provide operational oversight of packaging line equipment and serialization systems, including Antares interfaces and integration points
· Work cross-functionally with IT to ensure effective utilization of TraceLink and Oracle ERP for transaction visibility and data accuracy
· Support issue resolution across system interfaces (Antares → TraceLink → Oracle)
· Partner with Engineering and Validation to ensure systems remain qualified
Process Ownership & Continuous Improvement
· Own packaging and serialization-related processes, including SOPs and standard work
· Identify and implement improvements to enhance efficiency, reduce deviations, and improve data integrity
· Drive disciplined execution, visual management, and operational excellence within team
· Collaborate closely with Supply Chain Planning, Warehouse, Quality, Manufacturing, IT, and external vendors as required
· Support product launches, artwork changes, and lifecycle management activities
· Ensure packaging and serialization requirements are fully integrated into supply chain execution plans
· Other duties as assigned.
· Bachelors degree in Supply Chain, Operations Management, Life Sciences or related field required; advanced degree preferred.
· 5+ years of experience in pharmaceutical or biotech manufacturing, packaging, or supply chain operations
· Direct experience with commercial packaging and serialization operations
· Hands-on experience with Antares (or equivalent packaging line serialization systems) and TraceLink (or equivalent serialization platforms)
· Working knowledge of Oracle ERP within a regulated supply chain environment
· Strong experience working in GMP and GDP-regulated environments
· Proven experience with batch record execution/review and SOP management
· Demonstrated people leadership experience in frontline operations
· Strong problem-solving capability with the ability to troubleshoot across equipment, systems, and processes
· Excellent attention to detail and commitment to compliance and documentation accuracy
· Experience supporting product launches in a commercial-stage organization
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 $121,000 - $157,500. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.
We are an Equal Opportunity Employer.
Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response. Replimune is pioneering the development of novel oncolytic immunotherapies. We imagine a world where cancer is a curable disease.
Offices: Woburn, MA 01801, US
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