Job Detail

Project Manager Biologics Analytical Dept

Inseriert am: 10.03.2020
JOB DESCRIPTION

Job Description


Our Biologics Analytical Department located in Switzerland is part of our global Bioprocess Development Division. We are offering an attractive position for a scientist with biochemistry or biotechnology background. The candidate will support biotechnology process development in the role of specification and stability administrator in RLIMS (Research Laboratory Information Management System).


Furthermore, the job holder contributes proactively to regulatory IND filings, BLA filings and the preparation of CTDs. The role implicates a strong interaction with quality departments, R&D departments and Regulatory Affairs departments. The individual will also be a member of an international Analytical Development Team. The positon offers development potential; responsibilities can be adjusted to the candidate’s qualifications and ambitions.  


Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.


Main areas of responsibility include:



  • Setup and approval of analytical release and stability testing projects in RLIMS in the roles of specification and stability administrator

  • Planning and implementation of analytical projects conducted both locally and in cooperation with international service providers

  • Second Scientist Review of analytical data to ensure they meet company standards

  • Review and approve method validation plans and summaries

  • Coordinate analytical issues within the global biologics network

  • Prepare and execute analytical method transfers between a variety of CROs and company organizations

  • Being an active member of global bioanalytical development teams


Qualifications


Educational requirements:



  • Master with 3+ years of relevant Biotech or Pharmaceutical industry experience

  • Ph.D. in Biochemistry/Chemistry/Biological Sciences with 2+ years of relevant Biotech or Pharmaceutical industry experience


Required experience and skills:



  • Knowledge of RLIMS

  • Experience with drug substance and drug product release, stability and characterization for biologics

  • Experience with analytical method validation and transfers.

  • Strong project management and organizational skills

  • Comfortable with working as part of internal cross functional/cross divisional teams

  • Strong oral and written communication skills in English and German


 Preferred experience and skills:



  • Protein biochemistry and/or biochemical analytical techniques of proteins or with any biophysical methods

  • German language skills would facilitate on-site communication


We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.


Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Weystrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness. 


We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.  


At our Werthenstein BioPharma site in Schachen we research, develop and analyze new biological agents and new products, deliver clinical trial products for global clinical studies and operate one of our global forensic laboratories.


Who we are …


Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.


We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.


What we look for …


In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.


INVENT.


IMPACT.


INSPIRE.


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.


Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Domestic

VISA Sponsorship:


Travel Requirements:


Flexible Work Arrangements:


Shift:


Valid Driving License:


Hazardous Material(s):


Number of Openings:

1


Requisition ID:R41533

Details