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Experience with the regulation of biologics is essential; experience with gene editing and/or cell and gene therapy is preferred. Regulatory Submissions: Manage the Regulatory eCTD Content Planner for major filings, including investigational new drug applications (INDs), biologics license applications (BLAs), and marketing authorization applications (MAAs), tracking timelines and availability of deliverables from cross functional team to ensure accuracy, completeness, and timeliness.
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The Biologicals and Chemicals Division (BCD) is a ~$1.3B business within the BioProduction Group, supporting our BioPharma partners in the manufacturing of life-changing and life-saving biologics (Oncology, Autoimmune, Vaccines, Blood Disorders, Rare Diseases, etc.
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CSI Pharmacy is seeking a Specialty Account Manager for our Boston territory who will be responsible for establishing and maintaining relationships with referral sources in designated sales territory/region.
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CMC Vaccines authoring experience is preferred, but consideration will be given to those with strong CMC Biologics authoring experience. Consultant Regulatory CMC- Permanent - Boston, MAProclinical is seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant with a strong background in CMC post-approval.
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A minimum of 3 years' Experience working in a leadership position in Biologics or Plasma. Act as a consultant to the plasma center managers by helping to show best demonstrated practices within the industry.
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About the company:Our client offers preclinical services for drug discovery, focused on the use of nonhuman primates to determine pharmacokinetics, pharmacology and toxicology of small molecules and biologics.
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Deep experience in life sciences and pharma workflows, especially surrounding drug design and development, biologics, and new modalities (process chemistry, formulation, analytical); experience with drug manufacturing workflows preferred.
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You must effectively collaborate with staff and leaders in Device Development, Quality, Regulatory Affairs, Drug Development, Process Engineering and across other areas of Biologics Product Development at AstraZeneca.
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We are looking for a talented individual to join our dynamic Drug Product Development team within the Company’s Biologics CMC organization, where we drive the maintenance and evolution of both clinical and commercial products and programs.
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Familiarity with drug development processes for biologics. Leads the analysis of complex business problems and manages business requirements within area of responsibilities (Vaccine Manufacturing and Supply functions.
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Experience with viral vectors is not required but experience with biologics preferred. Innova Solutions is immediately hiring for a Quality Control Analyst II Molecular Biology. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP.
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Our Research & Development Division's Biologics Process Research and Development (BPR&D) department is seeking summer co-ops who will work collaboratively in a team environment at our state-of-the-art laboratories to develop novel bioprocess technologies and methodologies.
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Kivo is a modern document management platform that streamlines regulatory, clinical, and quality processes of critical drug and biologics programs. Kivo’s intuitive DMS and platform for Clinical, Regulatory and Quality team collaboration is typically purchased by fast-moving drug development companies.
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We are driven by discovering and developing regenerative biologics utilizing human placental tissue to provide breakthrough therapies addressing the unmet medical needs for patients across multiple areas of healthcare.
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Consult with clinicians as well as medical office staff (i.e. biologics coordinator) to appropriately promote Option Care Health and provide industry-leading customer service. With the nation’s largest home infusion provider, there is no limit to the growth of your career.
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biologics job in Boston, MA
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