Senior Scientist, Analytical R&D

Merck • Upper Gwynedd Township, PA

1d • Hybrid

About The Position

The selected candidate will work in the Pharmaceutical Analysis & 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 large molecule development programs at various stages of development. The scope of the role will include realization of the analytical R&D externalization strategy by building analytical capabilities and driving a culture of scientific and operational excellence 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 drug substance 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 large molecule development.

Requirements

• Ph.D. in Chemistry, Pharmaceutical Science, or related discipline OR Master’s degree with a minimum of 3 years of experience OR Bachelor’s degree with a minimum of 5 years of experience.
• Adaptability
• Analytical Method Development
• Analytical Validation
• Assay Development
• Bioanalytical Analysis
• Biochemical Assays
• Bioprocess Engineering
• Bioproducts
• Cell-Based Assays
• Chromatographic Techniques
• Critical Thinking
• Digital Technology
• Endevor
• Financial Forecasting
• GMP Compliance
• GMP Environments
• Innovative Thinking
• Operating Models
• Pharmaceutical Sciences
• Project Management
• Project Resource Management
• Strategic Thinking
• Technical Writing
• Ultra Performance Liquid Chromatography (UPLC)
• Vaccine Development

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 working independently in a fast-paced and dynamic environment and navigating competing priorities.
• Strong knowledge of biologics CMC landscape including knowledge of GMP, ICH and relevant HA guidelines.
• Strong understanding of regulatory validation guidelines and prior experience of successfully implementing validation best practices.
• Experience with a wide variety of analytical methods, including biochemical and biophysical characterization.
• Demonstrated track record of working across networks, both internally and externally, to deliver exceptional results aligned with program timelines.
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• Current Contingent Workers apply HERE
• US and Puerto Rico Residents Only:
• San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
• Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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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 place, introductions are position specific. Please, no phone calls or emails.

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, WG’s (Working Groups), Bioprocess Research & Development External Capabilities, and TPQM (Third Party Quality Management) to manage externalized projects.
• Lead analytical development for all large molecule drug substance and drug product deliverables sited at selected external partners including testing, analytical method qualifications/transfers, technical oversight, and resolution of analytical issues.
• Lead and apply project management skills to analytical method validation and transfer activities for pipeline commercialization projects, ensuring testing site readiness.
• 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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree