Molecular Biology Scientist I | Merck KGaA, Darmstadt, Germany

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Position: Molecular Scientist – Biosafety Testing 

Your role:

The Scientist will have scientific expertise in biologics safety testing focused on ​molecular biology​. They will ensure projects are carried out with the appropriate scientific and regulatory compliance oversight. They will also provide their scientific expertise to support investigations and client meetings. The Scientist will have the technical expertise to advice and support GLP / GMP operations. Responsibilities include reviewing proposals, acting as study director/responsible scientist on complex technical projects, responding to routine assay enquiries, reviewing and monitoring assay performance and lead scientific trouble shooting discussions during investigations. They will maintain an in-depth understanding of Process Solution Services, BioReliance services and technical principles as well as advances in the field.   

The ability to maintain effective working relationships with development services, commercial, SMEs from global PSS and laboratory personnel will be critical for success in the role. 

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

Brief role description:  

• Lead new assay and technology transfer 

• STUDY: Acts as a Study Director or Responsible Scientist for routine and complex assays and as such holds responsibility for the overall conduct of GLP or GMP studies, respectively 

• Plans, organises and prioritizes workload ensure testing are conducted timely and effectively issuance of studies Certificate of Analysis (COA)  

• Ensure routine and complex client studies are completed on time, to the appropriate scientific and regulatory standards 

• Works with Lab Manager/Manager on testing schedule for laboratory personnel 

• Works within the laboratory areas providing hands-on support, training, guidance, and mentorship to (​virology and detector cell culture​) laboratory personnel 

• Leads by example, acts as subject matter expert, offers scientific coaching and mentoring to other scientific laboratory personnel 

• Author, Reviewer and Approval for study and other technical scientific documents, such as amendments, Scientific protocols, Standard Operating Procedures (SOPs), workbooks, technical specification 

• Designs, directs and leads complex projects related to area of operational expertise 

• Ensures trending spreadsheets are completed in a timely manner for all studies in accordance with relevant SOP  

• Author and reviewer of assay risk assessments related to area of operational 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 

• Acts as point of contact for routine study enquiries  

• Works with Development Services to review proposals for projects  

• 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  

The above list of job duties is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post. Job descriptions will be regularly reviewed to ensure they are an accurate representation of the post 

Who you are:

Education: 

Experience: 

• Minimum 8 years of experience in a scientific laboratory role, ideally within a GLP / GMP contract testing laboratory environment 

• Demonstrable scientific expertise in ​molecular biology​ related works 

• 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 

HR: 87157

Functional Area: Research & Development

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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 our diverse team!