Associate Principal Scientist, Analytical R&D

Job Description Global Quality Large Molecule Analytical Sciences (GQ- LMAS) – Analytical Transfer Team New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in customer facing commercial or research based roles, will be required to be fully vaccinated as a condition of employment. Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Global Quality Large Molecule Analytical Sciences (GQ- LMAS), in our Manufacturing Division, is accountable for the commercialization of large molecule, vaccines and biologics, analytical techniques from Phase III through launch and transfer to supply. This team is highly motivated, fast-paced and focused on the rapid advancement of our Company's large molecule pipeline, plus growth of existing products. This position will involve oversight of late-stage method development, validation, and life-cycle management of methods but mainly global method transfer activities. Within the Global Quality Large Molecule Analytical Sciences (GQ- LMAS) organization, this Analytical Transfer Team include activities interfacing with a global network of product manufacturing and testing sites, collaborating with product development groups within our manufacturing division and our Research Laboratories division, continuous improvement of analytical methodology, assay validation, analytical technical transfer, and Biologics License Application preparation. Responsibilities Lead complex analytical transfers for the team including ADCs, mAbs and Vaccines Lead method transfers and/or validations across vaccine and biologics programs including quality risk assessments/gap analysis. Provide sponsorship of both in-line and pipeline analytical methods. The candidate will interface across our Company network and external partners to ensure the successful commercialization of assays promoting our pipeline programs Involvement in development, troubleshooting and optimization of analytical methods Continuous improvement using laboratory standardization, lean laboratory, and six sigma methodology Assay Life Cycle activities across various large molecule franchises and analytical platforms Promote various vaccine and/or biologics registrations, launches, and troubleshooting activities external to the US, including documentation preparation Direct strategic initiatives within departmental and cross-functional teams representing Global Quality Large Molecule Analytical Sciences (GQ- LMAS). Manage global registration and test on importation (TOI) activities Collaborating with commercial manufacturing teams to support facility start-up activities, New Product Introduction and provide analytical support both within our Company network and at contract manufacturing organizations (CMOs) or contract testing laboratories Education Bachelor’s degree in biology, chemistry, biochemistry, or related science with six years of relevant industry knowledge in systematic development, validation, and/or quality control (QC) or Master’s degree in biology, chemistry, biochemistry, or related science with four years of relevant industry knowledge in systematic development, validation, and/or quality control (QC) or PhD in biology, chemistry, biochemistry, or related science with one year of relevant industry knowledge in systematic development, validation, and/or quality control (QC) Knowledge | Skills Knowledge of ICH, USP and other compendial chapters required for method transfer and validation. Knowledge with late-stage method development, validation, and transfer Minimum two years working knowledge in a current Good Manufacturing Practices (cGMP) laboratory environment in large molecules (vaccines, biologics) Development and management of project timelines and deliverables Participation in cross-functional project teams Authoring and review of technical documents Ability to work objectively and within a cross-functional team Ability to learn new techniques Technical, verbal, and written communications, stakeholder management, and teamwork skills Self-motivated with a positive attitude and proven performance record Knowledge with drug substance and drug product release, stability, and extended characterization testing for vaccines and biologics Strong organizational and project management skills Ability to effectively identify and express risks ​ Preferred Deviation management and change control processes Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) Global launch or supply experiences Supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA) Continuous improvement or lean six sigma methodology Required Skills: Adaptability, Adaptability, Analytical Analysis, Analytical Method Development, Analytical Thinking, Assay Development, Biological Assay Development, Cell-Based Assays, Change Controls, Change Management, Chromatographic Techniques, Collaboration, Commercialization, Competency Management, Cross-Functional Teamwork, External Collaboration, High Resolution Mass Spectrometry (HRMS), Learning Agility, Liquid Chromatography-Mass Spectrometry (LC-MS), Mass Spectrometry Analysis, Optimism, Process Analytical Technology (PAT), Process Verification, Project Delivery, Project Leadership {+ 9 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US 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 applic