Framingham, Massachusetts, United States · On-site
$134k–$174k/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: GMP Compliance, Quality Assurance, Batch Disposition, GxP Regulations, CAPA
Boston, Massachusetts, United States · Hybrid
$181k–$225k/yr
About Us Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 8,000 employees across the group are united by a singula…
Skills: Pricing strategy, Market access, Reimbursement strategy, Contracting, Financial modeling
Boston, Massachusetts, United States · On-site
About Togetherhood At Togetherhood, we’re building something special: a vibrant marketplace where passionate educators meet schools and communities hungry for enrichment. Whether it’s arts & crafts, basketball, breakdanc…
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Boston, Massachusetts, United States · Remote OK
$191k–$300k/yr
Job Description We are seeking a Growth and Improvement minded Regional Medical Scientific Director (aka Medical Science Liaison, MSL) in Inflammatory Bowel Disease Immunology that can help drive our Strategic Operating …
Skills: Clinical Immunology, Clinical Trials, External Collaboration, Immunology, Inflammatory Bowel Diseases
New Bedford, Massachusetts, United States · Hybrid
$173k–$260k/yr
Why choose between doing meaningful work and having a fulfilling life? At MITRE, you can have both. That's because MITRE people are committed to tackling our nation's toughest challenges—and we're committed to the long-t…
Skills: Sensor Design, MATLAB, Python, Signal Processing, Algorithm Development
Boston, Massachusetts, United States · Hybrid
$181k–$225k/yr
About Us Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 8,000 employees across the group are united by a singula…
Skills: Gross-To-Net Forecasting, Financial Modeling, Market Access Strategy, Pricing And Reimbursement, Scenario Planning
Boston, Massachusetts, United States · Hybrid
$160k–$240k/yr
Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previo…
Skills: GCP Quality Assurance, Vendor Management, Clinical Audit Planning, QMS Management, Regulatory Compliance
Cambridge, Massachusetts, United States · On-site
$155k–$190k/yr
THE ROLE At Flagship Pioneering, we don’t wait for the future—we build it. Our origination model is like a startup foundry for breakthrough science and technology: we dream up bold ideas, pressure-test them fast, and lau…
Skills: Venture Hypothesis Development, Scientific Research, IP Strategy, Corporate Strategy, Business Development
Fall River, Massachusetts, United States · On-site
NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates. Job Title: Packaging Operator I - MDI - 3…
Skills: Pharmaceutical Packaging, cGMP, Equipment Maintenance, SOP Compliance, Quality Control
Boston, Massachusetts, United States · On-site
$150k–$250k/yr
Job Description: Note: Fidelity will not provide immigration sponsorship for this position. The Group Quantitative Research and Investing (QRI) is an investments and research division within Asset Management at Fidelity.…
Skills: Quantitative Research, Multi-Asset Systematic Strategies, Alpha Signal Development, Portfolio Construction, Risk Analytics
Framingham, Massachusetts, United States · On-site
$24k–$32k/yr
Job Title: Sr Manufacturing Technician Location: Framingham, MA About the Job: This is a 12-hour, rotating position in a large-scale cGMP biologics facility. The Sr. Manufacturing Technician will be responsible for perfo…
Skills: cGMP, Aseptic Techniques, Process Automation, DeltaV, Troubleshooting
Cambridge, Massachusetts, United States · Hybrid
$143k–$257k/yr
The Role Moderna is seeking an Associate Director of Clinical Operations to manage studies within the Oncology Therapeutic Area. This may include more than one study. This position will be responsible for initiating and …
Skills: Clinical Trial Management, Oncology, CRO Oversight, Budget Management, ICH/GCP Compliance
Westborough, Massachusetts, United States · Hybrid
Live Your Best Life at Lap of Love Veterinary Hospice! Join Lap of Love as an In-Home, Associate Veterinarian in Worcester, MA and surrounding areas. Imagine a veterinary role that honors your time, supports your well-be…
Skills: Hospice Care, Euthanasia, Veterinary Medicine, Compassionate Care, Client Communication
Shrewsbury, Massachusetts, United States · Hybrid
Live Your Best Life at Lap of Love Veterinary Hospice! Join Lap of Love as an In-Home, Associate Veterinarian in Worcester, MA and surrounding areas. Imagine a veterinary role that honors your time, supports your well-be…
Skills: Hospice Care, Euthanasia, Veterinary Medicine, Compassionate Care, Mobile Veterinary Practice
Auburn, Massachusetts, United States · Hybrid
Live Your Best Life at Lap of Love Veterinary Hospice! Join Lap of Love as an In-Home, Associate Veterinarian in Worcester, MA and surrounding areas. Imagine a veterinary role that honors your time, supports your well-be…
Skills: Hospice Care, Euthanasia, Veterinary Medicine, Compassionate Care, Mobile Veterinary Practice
Worcester, Massachusetts, United States · Hybrid
Live Your Best Life at Lap of Love Veterinary Hospice! Join Lap of Love as an In-Home, Associate Veterinarian in Worcester, MA and surrounding areas. Imagine a veterinary role that honors your time, supports your well-be…
Skills: Hospice Care, Euthanasia, Compassionate Care, Mobile Veterinary Medicine, Client Communication
Melrose, Massachusetts, United States · Hybrid
Live Your Best Life at Lap of Love Veterinary Hospice! Join Lap of Love as an In-Home, Associate Veterinarian in Salem, MA and surrounding areas. Imagine a veterinary role that honors your time, supports your well-being,…
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Peabody, Massachusetts, United States · Hybrid
Live Your Best Life at Lap of Love Veterinary Hospice! Join Lap of Love as an In-Home, Associate Veterinarian in Salem, MA and surrounding areas. Imagine a veterinary role that honors your time, supports your well-being,…
Skills: Hospice Care, Euthanasia, Veterinary Medicine, Compassionate Care, Mobile Veterinary Practice
Salem, Massachusetts, United States · Hybrid
Live Your Best Life at Lap of Love Veterinary Hospice! Join Lap of Love as an In-Home, Associate Veterinarian in Salem, MA and surrounding areas. Imagine a veterinary role that honors your time, supports your well-being,…
Skills: Hospice Care, Euthanasia, Compassionate Care, Mobile Veterinary Medicine, Client Communication
Boston, Massachusetts, United States · On-site
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Skills: Technical Accounting, External Financial Reporting, U.S. GAAP, Financial Statement Preparation, Audit Management
Framingham, Massachusetts, United States • On-site
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Responsible for ensuring GMP compliance and managing the batch disposition and release of drug substances and products across internal and external facilities. The role involves overseeing quality systems, managing product complaints, and driving continuous improvement through CAPA and deviation management.
Requires a Bachelor's degree in a science field and at least 6 years of experience in QA/Compliance within the pharmaceutical or biologics industry. Candidates must have deep knowledge of FDA and EU GMP regulations and experience with eQMS tools.
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.
This position is based in our Framingham location and typically has a 5-day on-site expectation.
Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to ensure inspection readiness.
Manage/coordinate internal and external batch release for GMP lots, through batch disposition and subsequent release and issuance of Certificate of Analysis / Conformance.
Manage Product Complaints for Commercial Product
Responsible for verifying all batches manufactured are compliant with Good Manufacturing Practices 21 CFR 210 and 211, product registration, marketing authorization and all other applicable requirements through review of testing records, investigations, non-conformances and out-of-specifications as part of the batch release process.
Reviewing packaging master batch records, packaging, labeling for investigational medicinal product.
Responsible for final approval and authorization of finished product for shipment and subsequent approval of packaging events.
Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance, including a summary of findings for any batch that does not meet the standard requirements for final disposition.
Drive improvement of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems including support of thorough root cause analysis investigations related to quality issues.
Oversee progression of batch related Out of Specification investigations and deviations to ensure timely progression for release.
Collect and provide input to and communicate performance metrics and data trends to Management for Batch Release related activities.
Lead, mentor and coach quality assurance personnel through development of training to support batch release activities/processes.
Support internal/external batch release audits as Subject Matter Expert.
As assigned
Bachelor degree in appropriate Science (chemistry, biology, biochemistry, microbiology) required; MSc or PhD preferred
Minimum 6+ years of experience in GCP, GMP, and Quality Assurance/Compliance in the pharmaceutical, biopharma/biologics industry performing direct hands-on work in Quality
Assurance, Quality Control, laboratories, manufacturing, supply chain, facilities, or
engineering.
A working knowledge of GxP practices, US FDA and EU GMP regulations and ICH
guidelines.
Demonstrated knowledge and direct experience with Quality Systems and GxP
compliance within a regulated environment.
Experience managing product complaints is preferred.
Experience managing quality events (i.e. Deviations, CAPA).
Experience with Master Control, Veeva or eQMS systems preferred.
Excel, PowerPoint, Word, SmartSheets proficient
Experience revising procedures and documents.
Excellent attention to detail.
Excellent verbal and written communication and presentation skills across all levels.
Prioritize and manage multiple priorities and projects with little assistance.
Familiarity with clinical and commercial supply areas and processes
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 $134,000 $173,500 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.
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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