Senior Scientist, Chemistry (Onsite)

Merck•Upper Gwynedd Township, PA

4d•Onsite

About The Position

The selected candidate will work in the Pharmaceutical Analysis and Digital Technologies (PADT) department within the Development Sciences and Clinical Supplies (DSCS) organization and serve as a primary point of contact for externalized analytical deliverables supporting small molecule drug substance and drug product programs at various stages of development. The scope of the role will include realization of the AR&D externalization strategy by leading the build of analytical capabilities and driving a culture of scientific and operational excellence within our team and at our external partners including oversight of a rapidly growing team of external analysts. The candidate will partner with cross functional Development and Commercialization Teams (DCT’s) and external partners to establish timelines for small molecule drug substance and drug product development and clinical deliveries 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 Process, Formulation, Engineering, 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 an analytical scientist seeking to gain externalization experience, lead the capability build at an external partner, provide oversight to multiple programs at any given time, and broaden their experience in small molecule development.

Requirements

Ph.D. in Chemistry, Pharmaceutical Science, or related discipline.
Master’s degree in Chemistry, Pharmaceutical Sciences, or related discipline with a minimum of 4 years of experience
Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related discipline with a minimum of 7 years of experience
Adaptability
Analytical Method Development
Biopharmaceuticals
Chemical Biology
Chemical Physics
Chemical Proteomics
Chemical Synthesis
Chemometrics
Chromatography
Data-Driven Decision Making
Financial Forecasting
Flow Cytometry
GMP Compliance
Mass Spectrometry Based Proteomics
Medicinal Chemistry
Motivation Management
Operating Models
Operational Excellence
Organizational Optimzation
Pharmaceutical Sciences
Process Analytical Technology (PAT)
Project Management
Project Resource Management
Protein Chromatography

Nice To Haves

Outstanding communication, critical thinking, and leadership skills.
Effective interpersonal skills and demonstrated ability to overcome challenges and align stakeholders toward a common goal.
Project management experience including resource management, budget forecasting, and risk assessment/mitigation planning.
Experience with working independently in a fast-paced and dynamic environment and navigating competing priorities.
Strong knowledge of small molecule CMC landscape including knowledge of GMP, ICH and relevant HA guidelines.
Experience with a wide variety of analytical methods, including chemical and physical characterization.
Demonstrated track record of working across networks, both internally and externally, to deliver exceptional results aligned with program timelines.

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, Working Groups, other external partner management and quality groups to manage externalized projects.
Lead analytical development for all small molecule deliverables sited at selected external partners including testing, 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 PADT stakeholders to author technical protocols, reports, and review technical documents.
Ensure high quality documentation from external partners consistent with a compliance mindset.