Senior Specialist Tech Transfer

vor 3 Wochen

Schachen LU, Luzern, Schweiz MSD Vollzeit

Job Description

As a member of the growing BPRnD at our Company, you will be responsible for the ensuring and supporting a fast and efficient Tech Transfer from development area to clinical manufacturing and from early clinical manufacturing to late Phase manufacturing to keep our Company at the forefront of clinical manufacturing of biologics.

The Senior Specialist Tech Transfer will be a member of the Our Company Manufacturing team, reporting to the Technology Transfer Lead. The successful candidate will be support the deployment of the multiproduct strategy and will work with stakeholders to support the introduction of new and resupply processes, materials, and technologies to Our Company, as well as transfer of processes out.

The Senior Specialist Tech Transfer role will be a Change Champion within the organization and site, to bring about new products, digitization, and ways of working.

Primary activities/responsibilities:

  • Coach team and support coordination of efforts with colleagues across the local site and network in shaping and implementing new tech transfer processes and innovation for GMP Batch and Continuous Manufacturing in Drug Substance
  • Support deployment of TT standards in compliance with our Quality Manual
  • Work with stakeholders to meet the transfer requirements of programs and timelines. TT activities including ownership and management of TT documents/schedules and TT technical studies
  • Contribute/lead tiered meeting structure support coordinating activities locally and with international (US, Ireland) groups for implementation of new processes for Drug Substance manufacturing.
  • Support/perform technical review of process descriptions, related documents and approval of Campaign summary reports
  • In person support for day-to-day TT delivery and execution, partnering with Operations and other stakeholders as required.
  • Engagement in facility fit activities, and participate on Global Development Commercialization Teams
  • 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
  • Support TT applicable risk assessments, complex changes, and complex investigations.
  • Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environment goals.
  • Ensure the highest Quality and Compliance standards

Required Education, Experience and Skills:

  • A minimum of 5 years of work experience in the pharmaceutical or biotech industry.
  • Bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
  • Familiarity with Unit Operations for monoclonal antibody manufacturing.
  • Competent in analyzing complex situations and show practical problem-solving capabilities with a desire to continuously learn, improve and develop.
  • Excellent time management and prioritization skills
  • Ability to think logically and be proactive under pressure.
  • Ability to work as part of a cross functional team and on own initiatives in a constructive manner.
  • Possess an understanding of a manufacturing/operational GMP (Good Manufacturing Practice) environment with experience of both upstream and downstream processing being a significant advantage

Preferred Experience and Skills:

  • Appropriate qualification in science or engineering
  • Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
  • Validation experience including validation documentation generation and execution
  • Familiarity with risk assessment processes
  • Experience of new product introduction and material management processes
  • Competency in the use of automated/digital systems such as DeltaV, MES, eVal, PowerBI

THE COMPANY

At our Company, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. Our Company has had a presence in Switzerland since 1963 and employs around 1000 people at five sites in the cantons of Lucerne and Zurich. We are proud to be certified as a "Top Employer Switzerland" and "Top Employer Europe" since 2012 showing the company's commitment to our employees and the community around us.

SCHACHEN, LUCERNE

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search 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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/23/2024

*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.

Job Posting End Date:06/23/2024

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.

Requisition ID:R295116

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