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Biologics/ Protein Therapeutics. Prepare and oversee IND enabling including regulatory CMC sections. Lead internal process development, optimization and tech transfer of upstream and downstream process development for clinical development pipeline.
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As part of the Biologics Engineering and Antibody Discovery team (BEAD), you will report to the Senior Director and work with the Global Biologics organization. Detailed knowledge of full biologics process from discovery to pre-IND.
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The BEC group drives a diverse portfolio of biologics drug discovery programs including various protein modalities, ADC and RLT through novel AI driven protein engineering and structure-based rational design approaches.
$153,600 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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This candidate will have a deep comprehension of biology (immuno-oncology biology, biologics, translation), including strong in vivo skills, strong leadership skills, the ability to incorporate emerging approaches into workflows, to provide scientific insights, and the ability to think critically about long-term strategy anticipating the future needs in the field of cell engagers and beyond.
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Experience in biologics, drug safety, pharmacovigilance and/or risk management preferred. The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
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In health, we focus on areas like medical countermeasures, advanced therapeutics, regenerative medicine, cell and gene therapies, biologics manufacturing, natural products, APIs and KSMs, enzymes, biocatalysis, and microbiome therapy to support national health security and public health initiatives.
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Discovery Biologics, Merck Research Laboratories (MRL) in Boston, is seeking a contractor to support molecular biology core. You will have the opportunity to apply your enthusiasm and technical skills as a member of Discovery Biologics - Boston to support and help drive multidisciplinary biotherapeutic discovery programs.
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Senior/ Principal Scientist, Cell Biology- Biologics. Experience nominating development candidates, ideally antibodies, protein therapeutics, or other types of biologics. As a member of our team, you will be responsible for designing and executing experiments to understand activity, mechanism of action, and therapeutic potential of early-stage biologics.
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Strong knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) with respect to biologics manufacturing and release/stability testing. Interact with internal cross-functional teams, including Analytical Development, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Alpine's/Vertex network of external CMOs/contract labs to support company's clinical programs.
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Strong experience developing biologics with specific experience in immuno-oncology/immunotherapy and immunology (auto-immune diseases) preferred. Serve as an internal partner to Regulatory Affairs to successfully secure regulatory approvals.
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15+ years of experience in biologics drug development or manufacturing in biotech or biopharma industry, with significant hands-on experience in areas of downstream process development and tech transfer, BLA enabling study and PPQ, commercial manufacturing, commercial supply, and product life cycle management.
$255,000 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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SUMMARY: We are seeking a highly skilled and experienced Principal Scientist in Biotherapeutics Engineering to design and optimize biologics-based drugs, incorporating structural biology expertise as well as innovative computational methods.
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Collaborate and enable teams to collaborate with cross-functional teams, including Global Biologics, Cell Therapy Technology and Product Engine, along with other research partners within and external to Takeda to develop and execute drug discovery strategies.
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Familiarity with molecular biology techniques, including PCR, restriction enzyme digestion, DNA purification, SDS-PAGE, western blot and microbial transformation (bacteria, yeast). The successful candidate will employ molecular biology and microbiology techniques to support all aspects of high-throughput molecular cloning including, DNA preparation, host transformation, host growth, protein expression, sample labeling, aliquoting, record keeping in our database and electronic notebook and other related tasks.
$27.5 an hourTemporaryExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.
$120,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago
biologics job Title: regulatory affairs in Boston, MA
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