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Merck Life Science

Scientist I - Biosafety Testing

5-8 Years
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  • Posted 22 hours ago
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Job Description

Work Your Magic with us!

Ready to explore, break barriers, and discover more We know you've got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role

The Scientist will possess scientific expertise in biologics safety testing, with a focus on Virology, Detector Cell Culture, and Client Cell Culture. This role involves ensuring that all projects are executed in accordance with the necessary scientific and regulatory compliance standards. The Scientist will leverage their expertise to support investigations and client meetings, providing valuable insights and guidance.

The Scientist will be able to perform the following functions independently, with minimal guidance.

What You Do

  • Lead new assay and technology transfer
  • Serve as the Study Director or Responsible Scientist for routine and complex assays, holding overall responsibility for the conduct of GLP or GMP studies.
  • Plan, organize, and prioritize workloads to ensure timely and effective testing, including the issuance of Certificates of Analysis (COA) for studies.
  • Ensure that routine and complex client studies are completed on schedule and meet the necessary scientific and regulatory standards.
  • Work with the Lab Manager to develop testing schedules for laboratory personnel.
  • Provide hands-on support, training, guidance, and mentorship to laboratory personnel in virology, detector cell culture and Client Cell Culture.
  • Provide hands-on support, training, guidance, and mentorship to laboratory personnel in molecular studies.
  • Leads by example, acts as subject matter expert, offers scientific coaching and mentoring to other laboratory staff.
  • Author, review, and approve study-related and technical scientific documents, including amendments, scientific protocols, Standard Operating Procedures (SOPs), workbooks, and technical specifications.
  • Ensure that trending spreadsheets for all studies are completed promptly and in accordance with relevant SOPs.
  • Author and reviewer of assay risk assessments related to your area of expertise
  • Ensures all assays / processes are in a validated state in line with current regulations
  • Responsible for maintenance and scientific integrity of routine and non-standard assays methods by monitoring assay performance and advising and implementing on improvements where necessary
  • Leads process improvements within the laboratory to improve quality and performance
  • Performs regular housekeeping laboratory check and Health and Safety audits
  • Host internal Quality Audit representing the laboratory; participate in client or regulatory audit
  • Responsible on audit observations response through the BioReliance Integrated Quality System (Trackwise)
  • Lead and ensure deviation and Corrective or Preventative Action (CAPA) records in a timely manner
  • Raise and progress Change Control for new service, testing, assay validation introduction
  • Acts as scientific consultant to support departmental investigations, client product queries, supplier audits and client/regulatory inspections
  • Liaises with Commercial, Development Services, Programme Management and other Laboratory Operations to provide technical support for ongoing and upcoming projects/studies, as required
  • Ensures a safe and healthy work environment at all times by not only complying with but actively embracing health and safety policies and procedures, ensuring the safety of yourself and others within the workplace
  • Conduct relevant bench work for client studies as assigned.

This list of job duties is not exhaustive, and the post holder may be required to undertake additional tasks as reasonably expected within the scope of the role. Job descriptions will be reviewed regularly to ensure they accurately reflect the position.

Who You Are

  • Minimum Degree in Biological Sciences or higher qualification in relevant scientific subject.
  • Minimum 5-8 years of experience in a scientific laboratory role, ideally within a GLP / GMP contract testing laboratory environment
  • Proven scientific expertise in virology, detector cell culture and client cell culture-related work.
  • Experience of working in Biosafety Level 2 laboratory

Knowledge & Skills

  • Computer literacy and entry of data into databases (LIMS, ELN, SAP, Oracle, etc.)
  • Ability to complete documentation (both handwritten and electronic) neatly and accurately
  • Strategy and business knowledge
    • Demonstrates customer centricity
    • Thinks and acts strategically
    • Can troubleshoot effectively
    • Understands the business
  • Operating skills
    • Puts safety first by adhering to health and safety procedures and actively takes necessary action when encountering unsafe situations
    • Orchestrates multiple activities in parallel to accomplish goals
    • Plans workload by assigning tasks appropriately depending on length and difficulty of task
    • Through effective communication, provides the information people need to know to do their jobs
  • Professional and Technical skills
    • Has the functional and technical knowledge and skills to do the job at a high level of accomplishment
    • Can learn new skills and acquire knowledge rapidly
    • Uses logic to solve complex problems with effective solutions
    • Shows sound judgement in decision making
    • Comes up with new and unique ideas and adds value in brainstorming settings
  • Energy and Drive
    • Self-motivated; is action-orientated and full of energy for the things he/she sees challenging, seizes more opportunities than others
    • Pursues everything with energy, drive and the need to finish, especially in the face of resistance or setbacks
    • Can be counted on to achieve goals, constantly and consistently, pushes self and others for results
    • Deals effectively with pressure; remains optimistic and persistent, even under adversity
  • Personal and interpersonal skills
    • Relates well to all kinds of people in the organization, builds constructive and effective relationships using diplomacy and tact
    • Is seen as a team player, cooperative, easily gains support of peers, encourages collaboration
    • Communicates effectively with others
    • Handles conflict effectively
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

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About Company

Job ID: 145065129