Job Description
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. 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 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.
We are currently seeking a
Senior Scientist, Analytical External Capabilities, Validation and Compliance (m/f/d) to work in the Analytical Research & Development (AR&D) department within the Development Sciences and Clinical Supplies (DSCS) organization and serve as a primary point of contact for externalized analytical deliverables supporting Biologic development programs at various stages of development. The scope of the role will include realization of the AR&D externalization strategy including the build of analytical capabilities externally and drive a culture of scientific excellence at our external partners.
The candidate will partner with cross functional Development and Commercialization Teams (DCT's) and external partners to establish timelines for API and drug product deliverables and will provide oversight of method development, method transfer, as well as release and stability testing for multiple programs. The candidate will also partner with Bioprocess, Quality, and interdivisional stakeholders to grow our relationships with select vendors by leveraging our company's ways of working and transform them into strategic partners.
This role represents an excellent opportunity for a scientist or engineer seeking to gain externalization experience, lead the capability build at an external partner, provide oversight to multiple programs, and broaden their experience in Biologics development.
Primary Responsibilities:- Execution of AR&D's externalization strategy and optimization of the operating model to deliver results aligned with enterprise goals
- Partner with cross functional DCT's and Bioprocess Research & Development External Capabilities to manage externalized projects
- Lead analytical development for all API and drug product deliverables sited at selected external partners including analytical method qualifications/transfers, technical oversight, and resolution of analytical issues
- Lead analytical capability build at selected external partners by identifying focus areas that support our company's current and future pipeline and working closely with internal SMEs to upskill external partners
- Partner with internal AR&D stakeholders to author technical protocols, reports, and review technical documents
- Ensure high quality documentation from external partners consistent with a compliance mindset
Education Minimum Requirements:- A Ph.D
- OR a Master's degree with a minimum of 2 years of experience
- OR a Bachelor's degree with a minimum of 5 years of experience
Preferred Experience & Skills: - Outstanding communication, critical thinking, and leadership skills
- Project management experience including resource management, budget forecasting, and risk assessment/mitigation planning
- Comfort with working in a fast-paced and dynamic environment
- Strong knowledge of Biologics CMC landscape including knowledge of GMP, ICH and relevant HA guidelines
- Extensive experience with a wide variety of analytical methods, including biochemical, biophysical characterization
- Demonstrated track record of working across networks, both internally and externally, to deliver exceptional results aligned with program timelines
- Travel (Domestic and/or International) up to 20% of time
THE COMPANY 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 (Tribschenstrasse, 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.
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 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:No relocation
VISA Sponsorship:No
Travel Requirements:25%
Flexible Work Arrangements:Not Applicable
Shift:Not Indicated
Valid Driving License:No
Hazardous Material(s):N/A
Job Posting End Date:10/1/2024
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