Analytical Project Lead (Associate Principal Scientist)

Job DescriptionAt 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.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.ResponsibilitiesCollaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in large molecule analyticsCoordinate with analytical and process development groups to prepare for and coordinate analytical troubleshooting, validation and technology transfers between our company, external partners and CMO/CROsGuide cross-functional teams and ensure alignment with analytical strategies and Quality Systems in support of analytical procedure lifecycle managementSteer teams of subject matter experts to develop and optimize existing biochemical, immuno-chemical and chromatography-based analytical methods to enable modernization of our testing strategiesAccountability for analytical method transfers and in-line assay method validations, including review of protocols and reportsRoutine assay monitoring and trending to ensure a robust analytical testing networkOwnership of product-specific global analytical methods including routine evaluation of methods for analytical lifecycle changesEscalation of key project challenges to management in a timely and concise mannerPartnership with critical reagent and reference standard groups to ensure unconstrained supply of reagents required for routine analytical testingPerform technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methodsCoordinate analytical issue resolution via subject matter experts within the global large molecule networkQualificationsRequiredBachelor’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) yearsEffective communication and teamworkExperience with large molecule GMP testing including drug substance and drug product stability and release testingExperience with analytical comparabilityExperience leading a cross-functional teamStrong technical expertise in general large molecule analytical laboratory operations, equipment and techniquesPreferredContinuous improvement or Project Management trainingExperience with global product supplyWriting or reviewing of regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections with multiple agencies (FDA, EMA, JNDA)Experience with large molecule analytical transfersExperience with change controlsExperience with assay monitoring and trendingRequired Skills: 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}Preferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your RightsEEOC GINA Supplement​We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State ActsThe salary range for this role is$142,400.00 - $224,100.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive, if applicab