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A basic understanding of formulation and drug product process development for biologics (antibodies, fusion proteins, bi-specifics, vaccines, antibody drug conjugates, etc. Experience with some scale-down/-up of biologics drug product process development activities; buffer preparations, testing using compendial methods (osmo, protein conc., pH, etc.
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Review Master Batch Records for accuracy and trend process data supporting process development or fill/finish manufacturing operations. good understanding / experience in biologics drug product process (freeze-thaw, filtration, mixing, filling, lyophilization.
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Author protocols, technical summary reports/memos and tech transfer documentation defining the manufacturing process and parameters. A minimum of 5+ years of experience with BS degree or 3+ years of experience with MS degree in Pharmaceutical Sciences, Biology, Biochemistry, Biochemical Engineering or a related scientific discipline.
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Degree in Chemical/Biochemical Engineering (or a related engineering discipline) or Pharmaceutical Sciences, and relevant industry experience that demonstrates expertise in drug product development as well as sustained excellence in performance and accomplishments that align to company goals.
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Some understanding of in-use stability and drug administration process and associated challenges (IV bags, subcutaneous injections) Protein formulation/stability of various dosage forms (liquid/lyophilized) employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods, analytical data analysis.
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Role: Senior Research Associate - Biologics Drug Product Development (BDPD). o Protein formulation/stability of various dosage forms (liquid/lyophilized) and configurations (vial/syringe), employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods.
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Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and Cell & Gene Therapy products.
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Previous experience interfacing with biologics drug product manufacturing sites and providing technical support during engineering runs/GMP operations is a plus. Seeking motivated, team-oriented individuals with scientific experience in laboratory work related to biologics.
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Title : Senior Research Associate - Biologics Drug Product Development (BDPD). Title : Senior Research Associate - Biologics Drug Product Development (BDPD). Experience working with Biologics molecules (proteins, mAbs); experience working with Client is a plus.
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Team Size - 11 full time employees; approx 20 total in pivotal Biologics DP function. o Scale-down/-up of biologics drug product processes. Be self-motivated, organized, thrive in team settings and enProduct scientific investigation and thinking, as well as be familiar with the relevant technical literature.
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Job Title: Senior Research Associate - Biologics Drug Product Development (BDPD) Job Title: Senior Research Associate - Biologics Drug Product Development (BDPD) Be self-motivated, organized, thrive in team settings and enjoy scientific investigation and thinking, as well as be familiar with the relevant technical literature.
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Background in organic-polymer synthesis and characterization, biocompatible polymers, peptides and lipid-protein-conjugates, oligonucleotides, structure-property relationships, formulation and process development, small & large molecules, analytical separations, isolation and identification of impurities.
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Generate Statements of Work (SOW) and detailed project plans for new process development activities. We are currently looking for a Senior Process Engineer to join our high-performing team in Carlsbad, CA.
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Basic understanding of formulation and drug product process development for biologics (antibodies, fusion proteins, bi-specifics, vaccines, antibody drug conjugates, etc. The Fountain Group are a national staffing firm and are currently seeking a Senior Research Associate - Biologics Drug Product Development for a prominent Pharmaceutical client of ours.
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Collaborate with the Sales team to support the acquisition of new clients, including participating in meetings, presentations, and proposal development as needed. Requirements:Proven experience (8+ years) in business development, go-to-market strategy, or related roles within tech or logistics is required.
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biochemistry process development jobs in Carlsbad, CA
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