Waltham, Massachusetts, United States · On-site
Position Overview The Senior Director, Biologics Drug Product Development and Manufacturing will provide program-specific leadership and subject matter expertise for biologics high-concentration formulation and pre-fille…
Skills: Biologics Formulation, Pre-filled Syringe Development, CDMO Management, CMC Strategy, Drug Product Manufacturing
Watertown, Massachusetts, United States · On-site
$195k–$275k/yr
Who we are: Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically im…
Skills: Clinical Operations, Project Management, Process Improvement, Operational Strategy, ICH-GCP
Boston, Massachusetts, United States · On-site
Company Description By working at Harvard University, you join a vibrant community that advances Harvard's world-changing mission in meaningful ways, inspires innovation and collaboration, and builds skills and expertise…
Skills: Molecular Cloning, PCR, RNA Extraction, NGS Library Preparation, Bacterial Genetics
Boston, Massachusetts, United States · On-site
Company Description By working at Harvard University, you join a vibrant community that advances Harvard's world-changing mission in meaningful ways, inspires innovation and collaboration, and builds skills and expertise…
Skills: Molecular Biology, Biochemistry, Extracellular Vesicle Isolation, Immunocapture, Biofluid Sample Processing
Boston, Massachusetts, United States · Hybrid
Company Description By working at Harvard University, you join a vibrant community that advances Harvard's world-changing mission in meaningful ways, inspires innovation and collaboration, and builds skills and expertise…
Skills: Pre-award Management, Post-award Management, Budget Development, Financial Analysis, Grant Compliance
Tewksbury, Massachusetts, United States · On-site
$80k–$110k/yr
Requisition Number: 75967 The company built on breakthroughs. Join us. Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of…
Skills: Internal Auditing, Supplier Quality Management, ISO Compliance, Data Analysis, Performance Metrics
Tewksbury, Massachusetts, United States · On-site
$112k–$154k/yr
Requisition Number: 75964 The company built on breakthroughs. Join us. Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of…
Skills: QMS Administration, ISO 13485, ISO 9001, CAPA Management, Document Control
Tewksbury, Massachusetts, United States · On-site
$67k–$92k/yr
Requisition Number: 75993 The company built on breakthroughs. Join us. Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of…
Skills: Computer Systems Validation, GxP Compliance, Data Integrity, Risk-based Validation, Technical Documentation
Tewksbury, Massachusetts, United States · On-site
$58k–$80k/yr
Requisition Number: 75970 The company built on breakthroughs. Join us. Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of…
Skills: Quality Auditing, ISO Compliance, Good Documentation Practices, Administrative Support, Internal Auditing
Fairhaven, Massachusetts, United States · On-site
$35/hr–$45/hr
Overview Registered Dietitian Monday - Friday with Flexible schedules Join Healthcare Services Group (HCSG) as a Registered Dietitian, where you will play a critical role in managing clinical nutritional services at a lo…
Skills: Clinical Nutrition Assessment, Care Plan Development, Nutrition Education, Patient Counseling, Interdisciplinary Collaboration
Boston, Massachusetts, United States · Hybrid
$242k–$314k/yr
About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and i…
Skills: CMC Regulatory Strategy, Biologics Development, ICH CTD Authoring, Health Authority Interactions, BLA Filing
Norton, 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 Norfolk County, MA and surrounding areas. Imagine a veterinary role that honors your time, supports your we…
Skills: Hospice Care, Euthanasia, Compassionate Care, Veterinary Medicine, Client Communication
Taunton, 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 Norfolk County, MA and surrounding areas. Imagine a veterinary role that honors your time, supports your we…
Skills: Hospice Care, Euthanasia, Compassionate Care, Mobile Veterinary Medicine, Client Communication
Attleboro, 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 Norfolk County, MA and surrounding areas. Imagine a veterinary role that honors your time, supports your we…
Skills: Hospice Care, Euthanasia, Veterinary Medicine, Compassionate Care, Client Communication
Franklin, 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 Norfolk County, MA and surrounding areas. Imagine a veterinary role that honors your time, supports your we…
Skills: Hospice Care, Euthanasia, Veterinary Medicine, Compassionate Care, Client Communication
Norton, 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 Norfolk County, MA and surrounding areas. Imagine a veterinary role that honors your time, supports your we…
Skills: Hospice Care, Euthanasia, Compassionate Care, Mobile Veterinary Medicine, Client Communication
North Attleborough, 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 Norfolk County, MA and surrounding areas. Imagine a veterinary role that honors your time, supports your we…
Skills: Hospice Care, Euthanasia, Compassionate Care, Mobile Veterinary Medicine, Client Communication
Mansfield, 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 Norfolk County, MA and surrounding areas. Imagine a veterinary role that honors your time, supports your we…
Skills: Hospice Care, Euthanasia, Compassionate Care, Mobile Veterinary Medicine, Client Communication
Attleboro, 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 Norfolk County, MA and surrounding areas. Imagine a veterinary role that honors your time, supports your we…
Skills: Hospice Care, Euthanasia, Compassionate Care, Mobile Veterinary Medicine, Client Communication
Marlborough, Massachusetts, United States · On-site
$69k–$88k/yr
Description Senior Research Associate, In Vivo Oncology Marlborough, MA About the Opportunity Meadowhawk Biolabs is seeking an enthusiastic and highly motivated Senior Research Associate to work within the In Vivo Oncolo…
Skills: In Vivo Oncology, Rodent Models, Dosing Skills, Animal Collection Techniques, Data Processing
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Lead the development and manufacturing of biologics high-concentration formulations and pre-filled syringes for preclinical and clinical programs. Oversee outsourced activities with CDMOs and contract labs to ensure technical quality, timelines, and budget goals are met.
Requires a Ph.D. or equivalent degree in biochemistry or chemical engineering with at least 10 years of biologics drug product development experience. Must have a proven track record in CDMO management and successful global CMC regulatory submissions.
Position Overview
The Senior Director, Biologics Drug Product Development and Manufacturing will provide program-specific leadership and subject matter expertise for biologics high-concentration formulation and pre-filled syringe (PFS) development and manufacturing in support of a best-in-class portfolio of preclinical and clinical programs. This leader will oversee the planning and execution of outsourced drug product development and manufacturing activities and will work proactively with external suppliers including CDMOs and contract labs to define project scope, mitigate risks, and ensure successful delivery with regard to technical quality, timelines and budget. The incumbent will collaborate with other functions to deliver quality drug products for preclinical studies and clinical trials and Module 3 Quality for regulatory submission and approval. The position requires strategic vision and hands-on experience managing early-stage biotech programs in a dynamic, fast-paced environment.
Responsibilities
Education & Experience
Skills & Attributes
Korsana Biosciences is the sixth groundbreaking company launched by Paragon Therapeutics, a premier biotech incubator founded by Fairmount Funds in 2021, known for its expertise in discovering and developing cutting-edge therapeutic assets in-house.
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Korsana Biosciences is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.
Korsana Biosciences is a private biopharmaceutical company advancing a pipeline of potential best-in-class therapies for neurodegenerative diseases. In partnership with Paragon Therapeutics, we have developed Therapeutic Targeting (THETA™), a novel blood-brain barrier-penetrant shuttle platform designed to enable dramatically higher drug concentration inside the brain and overcome the limitations of earlier shuttle technologies. Our lead program is KRSA-028, an investigational, shuttled antibody targeting amyloid beta designed to be a best-in-class treatment for Alzheimer’s disease. Our mission is to advance precision-engineered therapies, designed to address some of the biggest unmet needs in medicine. For more information, please visit www.korsana.com
Offices: Waltham, MA, US
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