Associate Principal Scientist, Analytical R&D

About the Role

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 includes 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
• 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 Qualifications

• 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, 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

Pay

The salary range for this role is $142,400.00 - $224,100.00. This 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 applicable.

Benefits

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

Schedule

Employee Status: Regular. Relocation: No relocation. VISA Sponsorship: No. Travel Requirements: 10%. Flexible Work Arrangements: Hybrid. Shift: 1st - Day.