Analytical Project Lead (Associate Principal Scientist)

The Analytical Project Lead role includes driving analytical strategy, managing analytical procedure lifecycle activities, maintaining a robust assay monitoring effort, participating in product strategy discussions, global method ownership, and many other cross functional activities. This position will require effective collaboration with external contract providers as well as colleagues in our research laboratories, supply chain, site, and global Quality, as well as CMC-Regulatory., * Collaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in large molecule analytics

• Coordinate with analytical and process development groups to prepare for and coordinate analytical troubleshooting, validation and technology transfers between our company, external partners and CMO/CROs
• Guide cross-functional teams and ensure alignment with analytical strategies and Quality Systems in support of analytical procedure lifecycle management
• Steer teams of subject matter experts to develop and optimize existing biochemical, immuno-chemical and chromatography-based analytical methods to enable modernization of our testing strategies
• Accountability for analytical method transfers and in-line assay method validations, including review of protocols and reports
• Routine assay monitoring and trending to ensure a robust analytical testing network
• Ownership of product-specific global analytical methods including routine evaluation of methods for analytical lifecycle changes
• Escalation of key project challenges to management in a timely and concise manner
• Partnership with critical reagent and reference standard groups to ensure unconstrained supply of reagents required for routine analytical testing
• Perform technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods
• Coordinate analytical issue resolution via subject matter experts within the global large molecule network

Required

• Bachelor’s Degree with a concentration in sciences with eight (8) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR Master’s Degree with six (6) years; OR PhD with three (3) years
• Effective communication and teamwork
• Experience with large molecule GMP testing including drug substance and drug product stability and release testing
• Experience with analytical comparability
• Experience leading a cross-functional team
• Strong technical expertise in general large molecule analytical laboratory operations, equipment and techniques

Preferred

• Continuous improvement or Project Management training
• Experience with global product supply
• Writing or reviewing of regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections with multiple agencies (FDA, EMA, JNDA)
• Experience with large molecule analytical transfers
• Experience with change controls
• Experience with assay monitoring and trending, Adaptability, Adaptability, Analytical Method Development, Analytical Testing, Assay, Assay Development, Biochemical Assays, Biological Assay Development, Cell-Based Assays, Chromatographic Techniques, Collaborative Communications, Cross-Functional Teamwork, Effective Written Communication, External Collaboration, Global Product Management, Global Supply Chain, GMP Compliance, GMP Operations, GMP Training, High Resolution Mass Spectrometry (HRMS), In Vitro Assays, Liquid Chromatography-Mass Spectrometry (LC-MS), Management Trainings, Mass Spectrometry Analysis, Optimism {+ 7 more}

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The salary range for this role is

$142,400.00 - $224,100.00

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We’re at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join us in our mission to use the power of leading-edge science to save and improve lives around the world., 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.