The Director of Science and Technology reports to the Executive Director of GMP Operations and will manage a team of 8-10 scientists that will be responsible for driving innovative analytical science to enable real-time characterization of novel biologics during manufacturing.
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 leader interested in positively impacting the development and commercialization of our company’s increasingly complex biotherapeutics.
The Director of Science and Technology reports to the Executive Director of GMP Operations and will manage a team of 8-10 scientists that will be responsible for driving innovative analytical science to enable real-time characterization of novel biologics during manufacturing. The team will be located at multiple sites including Schachen Switzerland and Dunboyne Ireland.
The Director will be responsible for setting scientific strategy across the GMP Operations team and encouraging an innovative culture that includes 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. 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 supervisors, and the GMP Operations leadership team to drive scientific strategy, new technology assessments, and operational advancement efforts
Managing a team of scientists for implementation of process analytical technology (PAT), mass spectroscopy, and automation-based methods
Timely communication and delivery of advanced analytical methods, data, and product knowledge needed to meet project milestones and associated regulatory requirements
Execution and oversight of critical analytical data for regulatory filings including composing/review of high-quality CMC sections for IND/CTA/NTAs
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
Qualifications:
Education:
Required:
Expertise in process analytical technology (PAT), including implementation of in-line or at-line analytics for continuous processing
Strong experience in analysis of biologics (e.g., Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX) and Capillary Electrophoresis (CE) techniques
Sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications
Strong background in analytical control strategy development and execution
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
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 ability to deliver complex objectives under aggressive timelines in a rapidly changing environment
A strong team player with excellent oral and written communication skills
Preferred:
Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP
Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein)
Knowledge and experience in Antibody Drug Conjugate method development
Strong external network to benchmark competitors and equipment vendors
Experience in high-throughput experimentation and data-rich experimentation
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.
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Current Contingent Workers apply HERE
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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.