Current Positions
GLP Testing Supervisor
AltheaDx, a world leader in the development of companion diagnostics and biopharma services has an opportunity for a GLP Testing Supervisor:
The successful candidate will coordinate with the Senior Director, Lab Operations and other departments to plan, schedule, and execute all aspects of testing operations in a GLP environment. He/She will be responsible for the implementation of procedures to optimize processes under regulatory requirements. The GLP Testing Supervisor will oversee and schedule testing operations and personnel within in GLP guidelines.
The successful candidate will interact and communicate with clients regarding testing. He/she will troubleshoot complex Testing Services process problems and issues. This position will coordinate with multiple departments including sales and quality on testing deliverables. With moderate supervision, the GLP Testing Supervisor will implement semi-complex testing and procedures to optimize processes under regulatory requirements. The successful candidate will be responsible for training other employees; writing/revising pertinent SOP’s; and drafting, reviewing, revising, and executing testing protocols, validation protocols, and study reports as necessary. Additionally, he/she will analyze data and results and provide conclusions and proposals. The GLP Testing Supervisor will research and identify new methods and technologies to enhance operations. Among other supervisory duties, the GLP Testing Supervisor will be responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating performance and rewarding as appropriate, disciplining and recommending termination when necessary.
The qualified candidate will have a Bachelor’s degree in a Life Sciences discipline or equivalent training and experience and a minimum of five (5) years relevant experience in a regulated testing laboratory environment. The GLP Testing Supervisor must be detail oriented with strong written and verbal communication skills. Familiarity with GLP regulations and an ability to assess impact of process deviations is required. Knowledge of RNA and DNA processes for downstream applications of Real-Time PCR, machine operations, and data presentation is necessary. Familiarity with Microsoft Office applications is a must.
AltheaDx performs assay development and clinical testing services for biopharma customers and physicians. Our biopharma service menu covers early stage biomarker discovery through companion diagnostics development, clinical trials and regulatory submission to FDA. AltheaDx is bringing theranostics into clinical use. Please visit our website http://www.altheadx.com for additional details. Resumes can be submitted to Adria Curtis acurtis@altheadx.com
Scientist, Product Development
AltheaDx performs assay development and clinical testing services for biopharm customers and physicians. Our biopharma service menu covers early stage biomarker discovery through companion diagnostics development, clinical trials and regulatory submission to FDA. AltheaDx is bringing theranostics into clinical use. Applicants should submit their resumes directly to Adria Stephanchick (astephanchick@altheadx.com).
Description: AltheaDx currently has an immediate opportunity for a Scientist in Product Development for assay and/or reagent development and validation for GLP and Clinical use. Involved during the entire product development process, from concept to product release, you will contribute to the identification of critical product performance attributes, the design of sensitive analytics to quantify the attributes, optimization of product formulations using these analytics, and verification/validation of the product design and manufacturing process. The successful candidate will independently design and perform the laboratory experiments and analyze the results by applying her/his knowledge in molecular biology and PCR. The scientist is responsible for accomplishing individual goals, meeting project timelines for the group and working together with other members to build a highly efficient and collaborative team. In addition to internal product development activities, you will participate in external technology assessments and competitive analysis studies in support of marketing collateral and potential technology acquisitions. Will offer novel approaches and troubleshooting to solve complex technical problems; train staff in scientific method and testing technologies; employ high level technical expertise to develop new techniques and creatively solve problems; reliably writes and executes well defined SOPs; interacts with clients to understand the project scope and prepares complex and detailed reports; complete other duties as assigned by supervisor.
Requirements: A bachelor degree with 12 years PCR/molecular biology related industrial experience, a master degree with 9 years experience or a Ph.D. degree with 3 years experience (preferably in a biotechnology or pharmaceutical R&D environment). A track record of publications in peer-reviewed journals and visibility within the scientific community are required. This position requires detailed knowledge of reagent product development. You must possess a deep molecular/biochemical understanding of a range of nucleic acid amplification and analysis methods (PCR, real-time PCR, and RT-PCR) and a desire to perform hands-on laboratory work. Experience in epigenetics, DNA methylation detection, mutation detection, CNV, microRNAs or RNAi is a plus. Strong communication skills and the ability to work independently on multi-disciplinary teams are essential. Knowledge of statistical methods and software for experimental design and data analysis in gene expression and genotyping is desired. Ability to evaluate and propose innovative technologies is a plus. Experience in development and commercialization of assay or reagent products under an ISO quality system and design control practices is also highly desirable.
Scientist, Assay Development (PCR Expert)
AltheaDx performs assay development and clinical testing services for biopharma customers and physicians. Our biopharma service menu covers early stage biomarker discovery through companion diagnostics development, clinical trials and regulatory submission to FDA. AltheaDx is bringing theranostics into clinical use. Applicants should submit their resumes directly to Adria Stephanchick (astephanchick@altheadx.com).
Responsibilities:
AltheaDx currently has an immediate opportunity for a PCR expert in the Assay Development group for PCR assay development and validation for GLP and Clinical use. This person will be responsible to independently develop, qualify and validate in house and customer real-time PCR and multiplex PCR assays to measure gene expression, copy number, genotype, translocations and other molecular characteristics of RNA or DNA, which will be used in clinical and pre-clinical quantitative and qualatitative biomarker and companion diagnostic studies. He/she will independently performs assay design, establishes assay development and validation protocol and carries out experiments; be responsible for accurate testing, documentation of results, and evaluation and analysis of data; provides technical and theoretical support to testing staff within area of specialty; researches and implements new methods and technologies to enhance operations; suggests improvements to existing methods and procedures; offers novel approaches and troubleshooting to solve complex technical problems; trains staff in scientific method and testing technologies; employs high level technical expertise to develop new techniques and creatively solve problems; reliably writes and executes well defined SOPs; interacts with clients to understand the project scope and prepares complex and detailed reports; complete other duties as assigned by supervisor.
Requirements:
A bachelor degree with 12 years PCR/molecular biology related industrial experience, a master degree with 9 years experience or a Ph.D. degree with 3 years experience. Detailed knowledge of PCR assay development and validation at clinical level and a minimum of 3 years proven experience in PCR assay development and validation is required. Familiarity with regulatory guidance on analytical testing and clinical molecular biology lab working experience is highly desired. Experience with assay development using FFPE fixed tissue samples is a plus. Demonstrated ability to understand and apply complex technical concepts to assay development methodology; detail oriented and strong written and verbal communication skills; ability to work independently, within prescribed guidelines, and as a team member; ability to follow detailed directions in a laboratory environment.
Testing Assistant/Associate
AltheaDx is looking to fill a position for a Testing Assistant/Associate. Applicants should submit their resumes directly to Adria Stephanchick (astephanchick@altheadx.com).
Responsibilities:
The successful candidate will be responsible for semi-routine testing and documentation of results. He/She will process nucleic acid isolation, PCR and analysis of data. The Testing Assistant will follow existing written SOP's and will accurately document data as required.
He/She may analyze results and present conclusions/deviations to manager while following well defined SOP protocols. This position will be responsible for routine maintenance of laboratory equipment and will assist other technical personnel on routine issues and problems.
The Testing Assistant will assist in the research and implementation of new methods and technologies to enhance operations. He/She will initiate revisions to current SOP as necessary according to GLP guidelines. The successful candidate will maintain a GLP environment; accordingly, he/she will collect and dispose of lab wastes according to established procedures.
Requirements:
The qualified candidate will have a Bachelor's degree in a Life Sciences discipline and two to four (1-3) years relevant laboratory experience.
The candidate must have a demonstrated ability to follow detailed instructions in laboratory environment as well as the demonstrated ability to understand and apply technical concepts to testing methodology as directed by senior staff. The successful candidate must be detail oriented and have excellent written and verbal communication skills. He/She must be familiar with Microsoft Office applications.
The position demands the ability to multitask; working independently on some projects while contributing to larger projects as a part of a team.