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BioPhase Solutions
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  • DMPK Project Representative  

    - San Diego
    Job DescriptionJob DescriptionPosition Overview:This role involves lea... Read More
    Job DescriptionJob DescriptionPosition Overview:This role involves leading efforts within the drug metabolism and pharmacokinetics (DMPK) area, working closely with multidisciplinary project teams to provide scientific insight and direction. The individual will oversee DMPK studies to support the company's drug development programs, both preclinical and clinical, and will contribute to project strategy and innovation. The position requires the ability to design, implement, and manage pharmacokinetic (PK), pharmacodynamic (PK-PD), and drug metabolism studies, combining various data points to optimize drug candidates. Responsibilities include preparing study reports, presenting data, and participating in regulatory submissions.
    Key Responsibilities:Act as the DMPK representative on cross-functional project teamsOversee and guide DMPK studies that support drug developmentDesign and execute PK, PK-PD, and drug metabolism studiesCollaborate with medicinal chemistry teams to optimize drug profilesIntegrate ADME, PK, and PK/PD data with biological findingsManage in vivo and in vitro ADME/PK studiesConduct modeling of PK and PK/PD, and predict human pharmacokineticsAnalyze DMPK data and develop studies to address project needsSummarize and present findings to stakeholders and teamsContribute to regulatory documents supporting drug developmentAuthor nonclinical PK/ADME documents for submissionsLead and support the in-house DMPK teamCoordinate with contract research organizations (CROs) to ensure study quality and timelinesDesired Qualifications:PhD in a relevant scientific field, such as Biochemistry or Pharmaceutical Sciences, with at least 10 years of industry experienceStrong expertise in pharmacokinetics, drug metabolism, modeling, enzyme kinetics, and bioanalytical techniquesExperience designing and executing PK and PK-PD studiesFamiliarity with preparing nonclinical PK/ADME documents for regulatory submissionsProficient in software like Phoenix WinNonlin, Excel, and Prism; knowledge of PBPK modeling is a plusCore Competencies:Strong communication and leadership skillsAbility to work effectively both independently and as part of a teamExpertise in data-driven analysis and drug development strategiesExperience managing CRO relationships and a solid understanding of regulatory standardsProven ability to lead studies that contribute to drug discovery and regulatory filings Read Less
  • Project Manager I (temp)  

    - Orange County
    Job DescriptionJob DescriptionBioPhase Solutions specializes in recrui... Read More
    Job DescriptionJob DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Project Manager I (temp) to work for a leading Greater Orange County area pharmaceutical company.
    Pay Rate: $40-55/hour depending on experience3-month temp100% on-site
    Summary:The Project Manager I will develop, plan, direct and control projects associated with drug product manufacturing, aseptic processing and filling. They will oversee all aspects of projects by working directly with customers and internal support teams. The Project Manager will manage project timelines by setting milestones and assigning tasks as well as monitor and summarize project progress. They should possess a broad range of skills in process analysis, project planning, coordination, and project execution. Responsibilities:Assemble project teams, develop project plans and timelines, manage project budgets and costs, and conduct routine project meetings. Closely follow-up with projects to ensure project deliverables are met.Conduct routine project meetings with external customers and generate meeting minutes and action item logs.Assist in developing scope of work for drug product manufacturing projects and technical transfer. Manage project teams with strong communication and interpersonal relationship skills to ensure project objectives and milestones are reached.Direct and coordinate the activities of internal cross-functional project team members such as Engineering, Supply Chain, Quality Assurance, Manufacturing and Maintenance, demonstrating a strong ability to function well in a team environment.Responsible for the entire project lifecycle including project initiation, planning, execution, monitoring and closing. Report on Project budget and schedule adherence, issues and mitigations, scope changes to senior leadership.Experience:BS Degree in science, engineering, or related field PMP Certification preferred1-4+ years of industry-related product management experienceKnowledge and experience with pharmaceutical manufacturing processes and equipment strongly desired.Aseptic manufacturing experience preferred. Sterile ophthalmic solution and suspension as well as sterile semi solids experience desired.Demonstrate Project Management knowledge tools, techniques, and culture. Strong computer skills. A solid knowledge of Microsoft Office programs.Product development and sustaining engineering knowledge is a plus.Strong knowledge of GMP’s, CFR’s, ICH, and ISO Regulations and familiarity with OSHA, EPA, and other federal and local regulatory requirements.Please send resumes to tiffany@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!! Read Less
  • Project Manager I  

    - Orange County
    Job DescriptionJob DescriptionBioPhase Solutions specializes in recrui... Read More
    Job DescriptionJob DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Project Manager I to work for a leading Greater Orange County area pharmaceutical company.
    Salary: $90-115k depending on experience
    Summary:The Project Manager I will develop, plan, direct and control projects associated with drug product manufacturing, aseptic processing and filling. They will oversee all aspects of projects by working directly with customers and internal support teams. The Project Manager will manage project timelines by setting milestones and assigning tasks as well as monitor and summarize project progress. They should possess a broad range of skills in process analysis, project planning, coordination, and project execution. Responsibilities:Assemble project teams, develop project plans and timelines, manage project budgets and costs, and conduct routine project meetings. Closely follow-up with projects to ensure project deliverables are met.Conduct routine project meetings with external customers and generate meeting minutes and action item logs.Assist in developing scope of work for drug product manufacturing projects and technical transfer. Manage project teams with strong communication and interpersonal relationship skills to ensure project objectives and milestones are reached.Direct and coordinate the activities of internal cross-functional project team members such as Engineering, Supply Chain, Quality Assurance, Manufacturing and Maintenance, demonstrating a strong ability to function well in a team environment.Responsible for the entire project lifecycle including project initiation, planning, execution, monitoring and closing. Report on Project budget and schedule adherence, issues and mitigations, scope changes to senior leadership.Experience:BS Degree in science, engineering, or related field PMP Certification preferred2-4+ years of industry-related product management experienceKnowledge and experience with pharmaceutical manufacturing processes and equipment strongly desired.Aseptic manufacturing experience preferred. Sterile ophthalmic solution and suspension as well as sterile semi solids experience desired.Demonstrate Project Management knowledge tools, techniques, and culture. Strong computer skills. A solid knowledge of Microsoft Office programs.Product development and sustaining engineering knowledge is a plus.Strong knowledge of GMP’s, CFR’s, ICH, and ISO Regulations and familiarity with OSHA, EPA, and other federal and local regulatory requirements.Please send resumes to tiffany@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!! Read Less

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Astrid-Lindgren-Weg 12 38229 Salzgitter Germany