Senior Methods Specialist (m/f/d), Analytical technology Solutions (ATS)

Job title: Senior Methods Specialist (m/f/d), Analytical technology Solutions (ATS)

Company: MSD


Job description: Job DescriptionDid you always want to work in a company where your work can have a real impact on people’s & animal’s lives? Are you ready to Invent, Impact, Inspire? We would like to meet you!We have an exciting new job opportunity at our location in Krems and are looking to hire aSenior Methods Specialist (m/f/d), Analytical technology Solutions (ATS)Purpose of the role:
Under the direction of the Associate Director ATS Bio, the senior method specialist is responsible for the on-site support of complex, strategic analytical projects that support the Krems QC laboratories and the bio process technology (BTS) group. You will take the lead in projects related to QC test transfers, test remediation/improvement, troubleshooting and/or test development, being responsible for activities including planning and coordination, execution, validation, and implementation. You involve, motivate, and align with (cross-functional) project team members, report back to stakeholders with clear communication skills, and take full ownership to drive results. In addition, you will train and mentor junior team members, being functionally responsible for their performance.Welcome in our team!The Analytical Technology solution – Bio (ATS-Bio) team is part of the larger ATS (Analytical technology Solutions) department supporting all Animal Health manufacturing sites on analytical topics. ATS-Bio Krems supports the on-site Quality Control (QC) laboratory with data analysis, troubleshooting, improvement and validation of analytical tests, coordination of method transfer activities between QC sites, as well as development and implementation of new technologies and test methods. The activities are very diverse and involve cross-functional interaction with various departments e.g. (Global) Regulatory Affairs, (Global) Quality, the BTS organization, R&D, Center for Mathematical Sciences (CMS). The ATS Krems team is currently being set up offering a great opportunity to bring you experience, ideas and contribution.Main responsibilities :Supports strategic development and execution of local (and regional) remediation/robustness programs.Ownership of test remediation activities at Krems site; support regional and global representation where appropriate. This includes periodic activity updates, conference calls, and face to face meetings. Requires extended knowledge of site QC laboratory capabilities (competencies, equipment, space, and general test format and execution) and capacities.Works with the ATS Bio lead, site Quality, Tech Services, and Operations managers to identify robustness opportunities and provide support as needed.Works with the ATS Bio lead to ensure Quality Control Method Remediation and Improvement efforts (QC Method Robustness) are aligned with Product Remediation and Improvement (Product Robustness) efforts where feasible.Works with the ATS Bio lead to ensure remediation and investigation priorities are supported by Site and Global Operations Management and Quality OperationsRepresents shop floor concerns related to Quality Control Method remediation and improvement efforts at site to support informed decisions regarding project prioritization, resource allocation, and risk management.Supports or leads ad-hoc local investigations as needed.Leads major Method development projects with a high degree of independence, in cooperation with R&D and Quality partners as appropriate.supports feasibility assessment and implementation of new technologies in cooperation with R&D and Quality partners.Independently performs Method transfers and gap assessments.Performs co-development/Single POC activities with high degree of independence.Owns and executes training programs for site.Activities include bench work and/or site level support.Your profile :Master’s or bachelor’s degree in a Biological or Pharmaceutical science required.Sound experience in the research, manufacture, and testing of (Sterile) Biological products. Conceptual and practical expertise in a relevant biological area with experience in other areas.Senior expertise in biological assay development (ELISA) and troubleshooting to include complex assay and product investigations.Holistic understanding of critical aspects in analytical (bio) method validations, transfers & implementation.Experience in leading site level assay and product investigation is preferred.Ability to work independently and make decisions in a constantly changing environment.Proficient in technical writing and current computer usage (Word, Excel, PowerPoint, etc.).What we offer:We welcome you to a truly global, dynamic, and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.Competitive salarySolid Pension PlanAnnual bonus based on own and company performance.Numerous training, coaching, and e-learning modules for long term job opportunities and development.The minimum annual salary for this position is EUR 61.300 and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees applyCurrent Contingent Workers applySearch Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: 10%Flexible Work Arrangements: HybridShift: Not IndicatedValid Driving License: NoHazardous Material(s): N/AJob Posting End Date: 02/13/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Expected salary: €61300 per year

Location: Krems An Der Donau, Niederösterreich

Job date: Fri, 17 Jan 2025 08:57:52 GMT

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