Senior Scientist, Clinical Biomarker Development &Validation Strategy 8/31/2016

EMD Serono Billerica, MA

Company
EMD Serono
Job Classification
Full Time
Company Ref #
151261
AJE Ref #
576026966
Location
Billerica, MA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Doctoral Degree

JOB DESCRIPTION

APPLY
Main Responsibilities

* Responsible for design and execution of well-defined experiments in lab.

* Evaluate data from internal lab(s) and/or or external collaborators/partners/ contract research organization (CROs). Prepare summary presentations or documents for reviewing by other team members/colleagues.

* Support clinical biomarker and/or companion diagnostic (CDx) assay development, validation & transfer through conducting internal laboratory work and/or monitoring of CROs), in vitro diagnostics (IVD) manufacturing and/or testing partner.

* Responsible for daily lab operation and ensure safe laboratory practices.

* Implement and maintain quality procedures in lab that comply with site procedures and regulatory requirements. Review & approve electronic and /or paper laboratory notebook

* Provide technical training/mentorship for associate scientist (s). Assist with vendor qualification and monitoring activities.

* Contribute to implementation of fit for purpose clinical biomarker assay development and transfer.

* Participate in TIPs and/or other internal/external collaborators/partners biomarker assay transfer & alignment meeting on as needed base.



EDUCATION/LANGUAGES

* PhD in cell biology, immunology, molecular biology, biochemistry or relevant scientific discipline with at least 5 years of experience in biotech/pharmaceutical industry.



Required Qualification & Professional Skill

* Proved in-depth expertise and hands-on experience in a variety of nucleic acid extraction and clinical molecular & genomic techniques (e.g. RT-PCR, RNA sequencing, NGS, WGS etc.) is required.

* Working knowledge of a variety of cellular and biochemical assays. Hands on experience in genomics and protein biomarkers. Demonstrated ability to develop a research plan and conduct experimental work.

* Demonstrated ability to interpret and summarize scientific data in an accurate and concise manner.

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

* Experience in clinical biomarker assay development, validation & execution in clinical trials and/or development of CDx.

* Experience of developing assays in partnership with CROs and/or external IVD manufacturing partners.

* A good understanding of translational and precision medicine approaches/applications in early and late stage clinical trial design, proof-of-concept studies.

* Knowledge of cancer biology/ cancer immunology and experimental techniques. Industry experience with oncology therapeutics and/or immunotherapy.





PERSONAL SKILLS & COMPETENCIES

* Strong interpersonal skills.

* Good presentation and excellent communication skills.

* Able to train and supervise junior scientist(s) in laboratory.

* Demonstrated ability to work effectively both independently and collaboratively in a dynamic, team-oriented matrix environment.

* Able to work independently toward defined goals.

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



Preferred Skill & Experience

* Five years of experience in clinical biomarkers, translational research and/or CDx development in a pharmaceutical/biopharmaceutical companies.

* Hands-on experience in digital PCR, NGS, ligand binding assay, flow cytometry and/or histopathology.

* Familiarity with clinical biomarker assay development/qualification and experience with -omics technologies.

* Clinical genomic lab experience and/or Experience in clinical biomarker assay optimization and transfer to CROs.

* Trained in the use of statistical analysis software (JMP, Minitab, SigmaStat, etc.)

* Previous supervisory experience



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.