Job Description
Job Description:
The GMP Operations branch of Biologics Analytical Research & Development (BAR&D) department within our Analytical Research and Development (AR&D) organization is seeking a highly motivated and innovative scientific leader interested in positively impacting the development and commercialization of our company’s increasingly complex biotherapeutics.
The Principle Scientist will report to the Director of Science & Technology GMP Operations and will be responsible for setting scientific strategy across the Science & Technology team and the wider BAR&D GMP Operations department. That includes encouraging an innovative culture that promotes new technology, novel techniques, and operational excellence across all activities.
Our BAR&D GMP Operations team is responsible for the validation of analytical methods and the subsequent release and stability testing of biologic therapies in the clinical space, including real-time characterization of novel biologics during manufacturing. Our efforts enable programs across the clinical development continuum to impact the health and wellness of patients worldwide.
Responsibilities include, but are not limited to, the following:
Partnering with technical experts and leadership within BAR&D GMP and across relevant business units involved in the application life cycle to drive scientific strategy for PAT (Process Analytical Technology), for new technology assessments, and for operational advancement efforts.
Analysis, (re)definition and implementation of business processes and life cycle management for PAT and related analytical applications within the Biologics space from early-stage development to commercial manufacturing. This requires effective cross-disciplinary and cross-functional collaboration.
Mentoring of scientists across BAR&D GMP towards effective cross-disciplinary collaboration and regulatory strategy on PAT and advanced analytical applications.
Exemplify scientific excellence internally and externally. Demonstrate expertise in our subject matter area educating our collaborators and developing peer relationships on high-performing project teams.
Responsible for setting high standards, building, and managing a high performing team. With the leadership team, sets department goals and performance objectives, supports talent development, and proactively addresses performance issues. Supports recruiting/hiring/developing talent as appropriate to grow and progress the organization.
Facilitation of teamwork, fostering productive communication with staff & colleagues and coordinates execution of plans with key team & stakeholders including necessary follow-up/tracking.
Qualifications:
Education:
PhD in relevant scientific discipline with 8+ years’ experience; MS in relevant scientific discipline with 12+ years’ experience; BS in relevant scientific discipline with 16+ years’ experience
Required:
Experience in analysis of biologics (e.g. Liquid Chromatography, Bioassay methods)
Sound scientific understanding of Critical Quality Attributes/Quality by Design/Design of Experiments principles as well as data analysis and statistics for setting specifications.
Understanding of technical problem solving, innovative research experience and demonstrated ability to communicate scientific concepts through publications, patents, presentations, or other professional/scientific achievements, including authoring and reviewing of internal technical reports, and regulatory filings.
Strong background in analytical control strategy development and execution.
Demonstrated understanding of automation, data engineering and data visualization in pharmaceutical manufacturing
Demonstrated ability to develop talent through good leadership and mentoring skills.
Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
Deep working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses (biologics license application submission) and interacting with health authorities.
Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
An effective collaborator with the ability to work both independently and in cross-functional teams to deliver on ambitious goals. A strong team player with excellent oral and written communication skills.
Desire and ability to learn new concepts outside of core expertise and training.
Excellent scientific communication skills, demonstrated creativity, and effective interpersonal skills.
Preferred:
Experience in PAT, including implementation of in-line or at-line analytics for continuous processing.
Knowledge of mammalian cell culture processing and process development
Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP<1033>.
Strong external network to benchmark competitors and equipment vendors
Experience in high-throughput experimentation and data-rich experimentation
Advanced understanding of organic chemistry and biochemistry
Solid computer skills, experience with automated laboratory instrumentation, and independent analytical problem-solving capabilities.
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 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.
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.
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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/ARequired Skills:
Analytical Method Development, Analytical Method Development, Assay Development, Bioanalytical Analysis, Biochemical Analysis, Biochemical Assays, Biologics License Application (BLA), Business, Business Processes, Business Process Modeling, Cell Cultures, Chromatographic Techniques, Clinical Judgment, Cross-Functional Teamwork, Dosage Forms, Ethical Compliance, GMP Compliance, Innovation, Learning New Concepts, Liquid Chromatography (LC), Mammalian Cell, Mammalian Cell Culture, Management Process, Matrix Management, Mentoring Staff {+ 5 more}Preferred Skills:
Job Posting End Date:
08/19/2025- 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:R358184
