Associate Scientist, Clinical Biomarker Development & Validation Strategy

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POST DATE 8/31/2016
END DATE 12/1/2016

EMD Serono Billerica, MA

Company
EMD Serono
Job Classification
Full Time
Company Ref #
151262
AJE Ref #
576026965
Location
Billerica, MA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
Main Responsibilities

* Supports clinical biomarker and/or companion diagnostic (CDx) assay development through internal laboratory work.

* Under guidance of the senior level scientist (s), develop optimal experimental plans and troubleshoot experiments in lab on as needed base.

* Responsible for routine operation in the lab under guidance of senior level scientist(s) and/or lab manager.

* Assist with clinical biomarker assay development, validation and transfer to designated CROs.

* Participate in assessing new clinical biomarker and/or CDx technologies enable evaluation and/or implementation of various technologies as well as building internal lab capabilities.

* Work in lab for method development, equipment maintenance and provide hands-on lab training of other scientists.

* Assist in implement and maintain quality procedures & documentation in lab that comply with site procedures and regulatory requirements.

* Contribute to evaluation data from internal lab work and prepares summary presentations or documents. Contribute to submission of regulatory documents and scientific publications on as needed base.



EDUCATION/LANGUAGES

* M.S. or BS degree in a life science area is required, with minimum of 3 years of experience either in academic or industry settings.



Required Qualification & Professional Skill

* Skilled in standard molecular, cellular and biochemical lab techniques (i.e. Real Time PCR, Western blot analyses, immunoassay/ELISA, etc.)

* Strong understanding of quality-related operational and laboratory compliance requirements (CAP/CLIA, GCP, GLP etc.) for clinical biomarker and /or CDx development.

* Conduct assigned testing with minimal supervision within constraints of lab scheduling.

* Perform testing in accordance with SOPs and/or testing procedures. Maintain complete and comprehensive lab records for study integrity.

* Prepare /revise SOPs, laboratory records and other related documentation as assigned.

* Assist with training of laboratory personnel as needed/ assigned

* Contribute ideas and suggestions to improve standard laboratory techniques, protocols, and processes etc.

* Comply with company health and safety regulations & procedures.



PERSONAL SKILLS & COMPETENCIES

* Strong interpersonal skills.

* Highly self-motived and proactive.

* Able to work independently toward defined goal(s).

* Good presentation and communication skills

* Excellent prioritization and organizational skills combined with flexibility to meet changing priorities.

* Demonstrate a consistently high level of quality of work.



Preferred Skill & Experience

* Previous experience in clinical biomarkers, translational research, regulated assay development/transfer and or CDx development in a pharmaceutical/biopharmaceutical setting.

* Previous hands-on experience with clinical molecular assay, or histopathology.

* Familiarity with multiple biomarker assay technologies (e.g. ligand binding assay, MSD, Luminex, NGS, RNA Sequencing etc.).

* Hands-on expertise using flow cytometry to identify subsets of immune cells, including Myeloid-derived Suppressor Cell (MDSCs), from in vitro cell cultures and tumor infiltrates etc.

* Clinical genomic lab experience.

* Trained in the use of statistical analysis software (e.g. JMP etc.).



ADA Requirements

* Normal and routine office duties

* Up to 10%l travel



EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.



Equal Employment Opportunity



The Company is an Equal Employment Opportunity employer.



No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.



This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.



Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.