Specialist Tech Transfer

Job DescriptionOur Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.Our company in Schachen serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees feel not only that they belong at Schachen, but that the site belongs to and is shaped by them.

The Biotech facility, at Schachen, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions.

Schachen Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline.The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change. A multi-product strategy for Technology Transfer and Facility Fit will enable the facility to adapt in a flexible and agile way for rapid product launchThe Specialist Technology Transfer (m/f/d) will be a member of the Manufacturing team, reporting to the Technology Transfer Lead. The successful candidate would be a responsible for supporting New Product Introduction, while also acting as a key contributor to the evolving site tech transfer strategy.The Specialist Technology Transfer (m/f/d) role will be a Change Champion within the organization and site, to bring about new products, digitization, and ways of working.Bring energy, knowledge, innovation to carry out the following:Responsibilities and activities can be tailored to successful candidate availability and career plan and would primarily entail, but are not limited to:Support of developing BPRnD tech transfer program. Collaborate with the team and stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material.Maintain and feed information delivered from Development in different digital tools such as COMET SAP, MES, and DeltaV. Manage new program introduction schedule to ensure tasks are executed on schedule and right-first time.Contribute/support in various teams as WAG manufacturing representative.Manages small projects with moderate resource requirements, risk and/or complexity.Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.Supports design and implementation of best practices in tech transfer. Assist in the development of future breakthrough business solutions, to reduce overall effort / reduce risk, optimizing these to make way for rapid product launch, to progress the team forward to “one-click” tech transfer.Provide feedback and propose opportunities for optimization to current Tech Transfer processes to incorporate lessons learned.Writing, maintaining of BOM's (Bill of material) and EBR’s, MES and SOPs/WI’s.Demonstrate excellent troubleshooting and problem-solving skills, as well as the ability to collaborate and work effectively within global and interdisciplinary teams.Demonstrate a desire for continuous learning, improvement, and development, while approaching problems from new perspectives.Support to aggregate process related knowledge and centralize for knowledge management.Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goalsEnsure the highest Quality, Compliance and Safety standards. Required Education, Experience and Skills: A degree qualification in a relevant field (Science/Technical)Minimum of 5 years of work experience in the pharmaceutical or biotech industryFamiliarity with Unit Operations for mAb manufacturingProject management basic knowledgeCompetent in issuing and transcribing information into documents required for manufacturing such as BOM, Batch Sheets and DeltaVCompetency in the use of automated/digital systems such as DeltaV, MES, eVal, SAP COMETHas managed a small project with a cross-functional groupWorking knowledge of cGMP regulationsUnderstanding of the general principles of New Product Introduction (Tech Transfer)Preferred Experience and Skills: Oral / written communication skills in English (C1) would be must and German (B1-2) would be desirableDemonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.Competent in analyzing complex situations and showing practical problem-solving capabilitiesFamiliarity with risk assessment processesCompetent in analyzing complex situations and showing practical problem-solving capabilitiesFamiliarity with the use of Automation systems in a manufacturing Process.Ability to work effectively as part of a team and independently.Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. Our Schachen site is crucial for the development and supply of innovative medicines. With over 400 employees, we focus on producing and testing new biological medicines. From Schachen, we export new drugs for global clinical trials, ensuring their safety and efficacy. Additionally, our site investigates suspected cases of drug counterfeiting, operating as one of only three such laboratories worldwide.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 apply HERECurrent Contingent Workers apply HERESearch 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:11/12/2024*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. SummaryLocation: CHE - Lucerne - Schachen (Werthenstein)Type: Full time

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