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Subject Matter Expert Immunoassays Job Opening @ Merck Oss Netherland

Subject Matter Expert Immunoassays Job Opening @ Merck Oss Netherland

Subject Matter Expert Immunoassays Job Opening @ Merck Oss Netherland: At Merck, we seek to discover and champion the latest, most promising advancements against the world’s greatest health challenges. To accomplish this, we are willing to invest in solutions that take us in directions we’ve never explored before. Because we’re on a relentless quest for cures. And we’ll be known differently in our industry because of it. Subject Matter Expert Immunoassays Job Opening @ Merck Oss Netherland

Subject Matter Expert Immunoassays Job Opening @ Merck Oss Netherland

Subject Matter Expert Immunoassays Job

Date: Jun 27, 2017

Location: Oss, NL

Subject Matter Expert Immunoassays-BIO004866

Subject Matter Expert Immunoassays Job Opening @ Merck Oss Netherland

Description

The department

The Biologics & Vaccines Analytics (BVA) supports the commercialization of vaccines and biotechnological derived pipeline products. Furthermore, BVA has a crucial role in supporting vaccines and biologics Operational Units (OpU) and the Quality Organization. As part of the BVA organization analytical Centers of Excellence are located in the US and Oss, The Netherlands. These teams are regionally responsible for support to OpU and Quality, and introducing new analytical methods into the commercial operations space.

The position

Reporting into the Team Lead SMEs, the Subject Matter Expert Immunoassays oversees all Enzyme Immunoassay (EIA, also referred to as ELISA) efforts from a scientific perspective and is able to translate current thinking and new advances into our analytical portfolio. In that role, the person establishes and maintains an internal and external network of EIA experts. Furthermore she or he indirectly guides all EIA related activities in the department and provides significant input into regulatory documents and responses to questions. This position does not have direct reports.

Roles and responsibilities include:

Scientific and Technical leadership (60% of average time spent)

  • Analytical SME, with deep scientific understanding of all EIA methods used for characterizing biotechnological products;
  • Responsible for best scientific practices within the lab space and supports troubleshooting, process support and life cycle management activities;
  • Writes complex technical documentation used for regulatory filings (e.g. justification of specifications and process characterization summaries);
  • Recruitment and supervision of MSc-level students.

Project leadership (40% of average time spent)

  • Participates in cross-functional/global CMC project teams and leads derived subteams (e.g. working groups responsible for analytical or drug substance development workstreams);
  • Participates as SME in solving technical problems at an international level;
  • Root Cause Analysis Lead for significant investigations (regional).

Qualifications

Desired skills & experience

  • PhD in biological sciences, biochemistry, or immunology or equivalent through experience;
  • Minimum of 5-10 years relevant experience in protein analytics;
  • Significant experience in analytical methodologies for quality control of biotechnological products;
  • Strong project management skills & proven ability to manage complex projects;
  • Knowledge of regulatory and quality guidelines, and knowledge on CTD format for IND/ BLA/ MAA submissions preferred;
  • Excellent analytical and technical skills;
  • Demonstrated initiative, and innovative process-oriented thinking within a team environment;
  • Excellent oral and written communication skills in English (Dutch is a plus).

About MSD

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

MSD. Be well. For more information, visit our website: www.werkenbijmsd.nl

A good place to work

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

Information:

For more information about this position you can contact Joop Waterval, Principal Scientist, by phone via 0031 (0)412-661884.

Application

If you are interested in this challenging role, you are requested to apply online by uploading your resume and application letter in English.

Job: Biologics, Vaccines, Analytical Formulat

Job Title: Subject Matter Expert Immunoassays

Primary Location: EMEA-Netherlands-NB-Oss

Employee Status: Regular

Number of Openings: 1

Company Trade Name: MSD

Job Segment: Biochemistry, Immunology, Biotech, Law, Project Manager, Science, Healthcare, Legal, Technology

Subject Matter Expert Immunoassays Job Opening @ Merck Oss Netherland

To Apply & View Original Notification: https://jobs.msd.com/MSD/job/Oss-Subject-Matter-Expert-Immunoassays-Job-NB/414739200/

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