Senior Methods Specialist

Did 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 a

**Senior 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 Operations
- Represents 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 salary
- Solid Pension Plan
- Annual bonus based on own and company performance.
- Numerous training, c