Qpex Biopharma, Inc
Bioanalytical Scientist IV / Bioanalytical Principal Scientist
Qpex Biopharma, Inc, San Diego, California, United States, 92189
Overview:
Qpex Biopharma is seeking an experienced, resourceful, hands-on individual to join our Pharmacology team in the role of Bioanalytical Scientist and External Studies Monitor. The position will manage all aspects of the conduct of bioanalytical methods development using chromatographic assays of small molecule therapeutics for discovery through clinical stages of R&D.
This position will manage internal and external nonclinical and clinical bioanalytical projects, communicate and manage CROs to ensure high quality bioanalytical data/reports to be delivered in accordance with project timelines. This position will report to the SVP, Nonclinical and Clinical Development and will interact with other team members in Clinical Operations, Pharmacology, Chemistry, Regulatory and Biology.
Detailed Description:
Analyze concentrations of compounds in various biological matrices to support studies of the absorption, distribution, metabolism, and excretion (ADME) experimental studies of small molecules in preclinical species.
Perform microsomal preparation and evaluation of metabolism of small molecules.
Develop bioanalytical methods using HPLC and mass spectrometry (e.g., LC/MS/MS) methods to support discovery activities related to small molecule therapeutics, including PK and drug metabolism to identify structure activity- and structure-property- relationships to assist in further structural optimization.
Perform bioanalytical assays of early absorption, distribution, metabolism, and excretion (ADME) experimental studies of small molecules.
Microsomal preparation and evaluation of metabolism of small molecules, including metabolite identification.
Analyze PK and biological data to identify structure activity- and structure-property- relationships to assist in further structural optimization.
Perform technical reviews of analytical data from external contract research organizations, and be responsible for data interpretation, analysis, and reporting of results for method development and validation.
Write technical reports describing bioanalytical work suitable for inclusion in regulatory packages.
Review and edit bioanalytical validation, assay, and drug metabolism reports from external contract organizations.
Negotiate contracts and work orders for external bioanalytical and drug metabolism.
Able to successfully transfer and oversee validation of bioanalytical methods to a CRO and oversee the subsequent analysis of clinical samples.
Act as the primary scientific interface between our CROs and Qpex for outsourced work and associated processes.
Evaluate CRO compliance and commitment to Good Laboratory Practices and worldwide regulations, relevant SOPs, protocols, policies, and procedures.
Engage with and participate in external audits with quality operations and officers to ensure work of the highest quality is being undertaken from a scientific perspective.
Qualifications:
The Scientist IV level requires a Ph.D. or equivalent degree in a related science field with a minimum of 8 years of experience; or equivalent combination of education and experience.
The Principal Scientist level requires a Ph.D. or equivalent degree in a related science field with a minimum of 10 years of experience; or equivalent combination of education and experience.
Able to design and oversee the execution of bioanalytical method development and validation studies internally using accepted industry methods with minimal guidance and supervision.
Knowledgeable of current FDA and EMA GLP compliance as it relates to bioanalytical methods.
Strong, hands-on experience of processes and techniques associated with method development / validation and study support using HPLC and LC-MS/MS as well as management of external contract bioanalytical services.
Excellent communication skills – will need to interface between many functional areas including CROs, Project Teams, Clinical organization, etc.
Current knowledge of relevant bioanalytical and industry regulatory guidance.
Proven ability to think critically and creatively to identify and solve bioanalytical assay development challenges.
Excellent written and verbal communication skills, and ability to write and review technical reports.
Excellent organizational skills, attention to detail and the ability to work independently and within a multi-disciplinary environment as well as with external vendors.
The base salary range for this full-time position is $160,000-$190,000 annually. This salary range is an estimate and may vary based on the Company’s compensation practices.
EEO:
Qpex Biopharma is an equal opportunity/affirmative action employer. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Qpex Biopharma to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.
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Qpex Biopharma is seeking an experienced, resourceful, hands-on individual to join our Pharmacology team in the role of Bioanalytical Scientist and External Studies Monitor. The position will manage all aspects of the conduct of bioanalytical methods development using chromatographic assays of small molecule therapeutics for discovery through clinical stages of R&D.
This position will manage internal and external nonclinical and clinical bioanalytical projects, communicate and manage CROs to ensure high quality bioanalytical data/reports to be delivered in accordance with project timelines. This position will report to the SVP, Nonclinical and Clinical Development and will interact with other team members in Clinical Operations, Pharmacology, Chemistry, Regulatory and Biology.
Detailed Description:
Analyze concentrations of compounds in various biological matrices to support studies of the absorption, distribution, metabolism, and excretion (ADME) experimental studies of small molecules in preclinical species.
Perform microsomal preparation and evaluation of metabolism of small molecules.
Develop bioanalytical methods using HPLC and mass spectrometry (e.g., LC/MS/MS) methods to support discovery activities related to small molecule therapeutics, including PK and drug metabolism to identify structure activity- and structure-property- relationships to assist in further structural optimization.
Perform bioanalytical assays of early absorption, distribution, metabolism, and excretion (ADME) experimental studies of small molecules.
Microsomal preparation and evaluation of metabolism of small molecules, including metabolite identification.
Analyze PK and biological data to identify structure activity- and structure-property- relationships to assist in further structural optimization.
Perform technical reviews of analytical data from external contract research organizations, and be responsible for data interpretation, analysis, and reporting of results for method development and validation.
Write technical reports describing bioanalytical work suitable for inclusion in regulatory packages.
Review and edit bioanalytical validation, assay, and drug metabolism reports from external contract organizations.
Negotiate contracts and work orders for external bioanalytical and drug metabolism.
Able to successfully transfer and oversee validation of bioanalytical methods to a CRO and oversee the subsequent analysis of clinical samples.
Act as the primary scientific interface between our CROs and Qpex for outsourced work and associated processes.
Evaluate CRO compliance and commitment to Good Laboratory Practices and worldwide regulations, relevant SOPs, protocols, policies, and procedures.
Engage with and participate in external audits with quality operations and officers to ensure work of the highest quality is being undertaken from a scientific perspective.
Qualifications:
The Scientist IV level requires a Ph.D. or equivalent degree in a related science field with a minimum of 8 years of experience; or equivalent combination of education and experience.
The Principal Scientist level requires a Ph.D. or equivalent degree in a related science field with a minimum of 10 years of experience; or equivalent combination of education and experience.
Able to design and oversee the execution of bioanalytical method development and validation studies internally using accepted industry methods with minimal guidance and supervision.
Knowledgeable of current FDA and EMA GLP compliance as it relates to bioanalytical methods.
Strong, hands-on experience of processes and techniques associated with method development / validation and study support using HPLC and LC-MS/MS as well as management of external contract bioanalytical services.
Excellent communication skills – will need to interface between many functional areas including CROs, Project Teams, Clinical organization, etc.
Current knowledge of relevant bioanalytical and industry regulatory guidance.
Proven ability to think critically and creatively to identify and solve bioanalytical assay development challenges.
Excellent written and verbal communication skills, and ability to write and review technical reports.
Excellent organizational skills, attention to detail and the ability to work independently and within a multi-disciplinary environment as well as with external vendors.
The base salary range for this full-time position is $160,000-$190,000 annually. This salary range is an estimate and may vary based on the Company’s compensation practices.
EEO:
Qpex Biopharma is an equal opportunity/affirmative action employer. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Qpex Biopharma to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.
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