Director- Analytical Chemistry & Business Operations
Director- Analytical Chemistry & Business Operations Yoh is hiring a Director of Analytical Chemistry & Business Operations to join our client in Alameda, CA.
The Director of Scientific & Business Operations position and will be responsible for helping to supervise and mentor a team of Analytical Chemists in several aspects of department operations including reporting, method validation/qualification, investigating deviations, and unexpected results within R&D and GLP/cGMP environment.
This person will serve as a liaison between our internal team and our Pharmaceutical clients.
Title:
Director- Analytical Chemistry & Business OperationsSchedule:
Monday-Friday.
8am-5pm, fully onsiteLocation:
Alameda, CASalary:
$140,000 to $180,000 Depending on ExperienceResponsibilities Consult with Clients on scientific needs, respond to RFPs, and establishes appropriate scope of work in collaboration with internal scientific teamsOutline scope of work, provide budgetary input, set project timelines, and anticipate technical challenges for each projectParticipate in client meetings, provide technical knowledge to help outline project requirements and address technical concernsWork with Study Directors/Principal Investigators (internal or external), and Quality Assurance teams to establish the design and conduct of studies in compliance with the protocol/amendments/planned changes, SOPs, and all applicable regulatory requirements, i.
e.
, GLP, GCP, ICH, etc.
Serve as a single point of contact for project directors and scientific team after project initiationOrganize and communicate complex data sets in a clear and concise manner to key stakeholders from diverse backgroundsReviews and approves reports, or reporting of results, within study timelines, and ensures any deviations/exception events are reflected as appropriate and assure that all analysis conducted is reported and is accurateCollaborate with Quality Assurance team to refine and enforce R&D and cGMP/GLP policies with emphasis on compliance to the company's Quality Management System (QMS) and external regulatory standards (FDA, EMA, etc.
)Work interactively and cooperatively with all functions of the company and with senior staff to help achieve the company's visionThese job requirements are not intended to be construed as an exhaustive list of all duties and skills required of the candidate.
RequirementsPh.
D.
in Analytical Chemistry is requiredAt least 7 years of pharmaceutical industry experienceAt least 3 years of progressive management responsibility or equivalent work experienceCandidate should be a strong team player with excellent oral and written communication skills and with a demonstrated ability to interpret data, troubleshoot, and suggest next stepsBroad scientific knowledge and technical understanding of GLP/cGMP compliance, ICH,/FDA guidelines.
Experience with writing regulatory documents for IND/NDA submission is preferredExperience with IND-enabling study design and management is preferredAppropriate technical experience of relevant laboratory techniques within a regulated environmentAbility to prioritize responsibilities and multi-task in a fast-paced environment with changing prioritiesProficiency in hands on analytical work while managing internal and external activitiesExhibit strong technical skills and the ability to critically evaluate raw data and results without supervisionMust be skilled in operation of chromatographic data acquisition and processing software packages such as Agilent MassHunter, Thermo Scientific Chromeleon Chromatography Data System (CDS) software, Bruker TopSpin, Waters Empower ChromScope, and other software tools for data reduction and presentationExperience with deposition, intellectual property and litigation-related projects a plus Any pay ranges displayed are estimations which may have been provided by job boards.
Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.
All qualified applicants are welcome to apply.
Note:
Any pay ranges displayed are estimations.
Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.
All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
The Director of Scientific & Business Operations position and will be responsible for helping to supervise and mentor a team of Analytical Chemists in several aspects of department operations including reporting, method validation/qualification, investigating deviations, and unexpected results within R&D and GLP/cGMP environment.
This person will serve as a liaison between our internal team and our Pharmaceutical clients.
Title:
Director- Analytical Chemistry & Business OperationsSchedule:
Monday-Friday.
8am-5pm, fully onsiteLocation:
Alameda, CASalary:
$140,000 to $180,000 Depending on ExperienceResponsibilities Consult with Clients on scientific needs, respond to RFPs, and establishes appropriate scope of work in collaboration with internal scientific teamsOutline scope of work, provide budgetary input, set project timelines, and anticipate technical challenges for each projectParticipate in client meetings, provide technical knowledge to help outline project requirements and address technical concernsWork with Study Directors/Principal Investigators (internal or external), and Quality Assurance teams to establish the design and conduct of studies in compliance with the protocol/amendments/planned changes, SOPs, and all applicable regulatory requirements, i.
e.
, GLP, GCP, ICH, etc.
Serve as a single point of contact for project directors and scientific team after project initiationOrganize and communicate complex data sets in a clear and concise manner to key stakeholders from diverse backgroundsReviews and approves reports, or reporting of results, within study timelines, and ensures any deviations/exception events are reflected as appropriate and assure that all analysis conducted is reported and is accurateCollaborate with Quality Assurance team to refine and enforce R&D and cGMP/GLP policies with emphasis on compliance to the company's Quality Management System (QMS) and external regulatory standards (FDA, EMA, etc.
)Work interactively and cooperatively with all functions of the company and with senior staff to help achieve the company's visionThese job requirements are not intended to be construed as an exhaustive list of all duties and skills required of the candidate.
RequirementsPh.
D.
in Analytical Chemistry is requiredAt least 7 years of pharmaceutical industry experienceAt least 3 years of progressive management responsibility or equivalent work experienceCandidate should be a strong team player with excellent oral and written communication skills and with a demonstrated ability to interpret data, troubleshoot, and suggest next stepsBroad scientific knowledge and technical understanding of GLP/cGMP compliance, ICH,/FDA guidelines.
Experience with writing regulatory documents for IND/NDA submission is preferredExperience with IND-enabling study design and management is preferredAppropriate technical experience of relevant laboratory techniques within a regulated environmentAbility to prioritize responsibilities and multi-task in a fast-paced environment with changing prioritiesProficiency in hands on analytical work while managing internal and external activitiesExhibit strong technical skills and the ability to critically evaluate raw data and results without supervisionMust be skilled in operation of chromatographic data acquisition and processing software packages such as Agilent MassHunter, Thermo Scientific Chromeleon Chromatography Data System (CDS) software, Bruker TopSpin, Waters Empower ChromScope, and other software tools for data reduction and presentationExperience with deposition, intellectual property and litigation-related projects a plus Any pay ranges displayed are estimations which may have been provided by job boards.
Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.
All qualified applicants are welcome to apply.
Note:
Any pay ranges displayed are estimations.
Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.
All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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