Shift :
Monday through Friday, 8 : 00AM - 5 : 00PM with some flexibility
Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.
mRNA Analytical Development Project Manager
Position Overview
We are seeking an experienced mRNA Analytical Development Project Manager to drive strategic partnerships and manage analytical development activities for our cutting-edge mRNA vaccine and therapeutic programs. This pivotal role combines project management excellence with analytical expertise to orchestrate complex testing operations across external partners while supporting internal development teams.
Compensation : $99,000.00 - 114,000.00 per year
Key Responsibilities
External Partner Management
- Lead strategic partnerships with Contract Testing Laboratories (CTLs) and Contract Development and Manufacturing Organizations (CDMOs) for analytical testing, method development, qualification, and validation activities
- Plan, monitor, and drive successful completion of analytical testing programs with external partners, ensuring timely delivery of high-quality results
- Proactively identify and mitigate risks in external testing programs, leveraging experience to predict and address potential roadblocks before they impact timelines
- Demonstrate familiarity with Quality Systems, including Master Service Agreements (MSAs), Quality Technical Agreements (QTAs), and other technical documents
- Coordinate sample shipments between internal laboratories and external testing facilities
Project Leadership & Execution
Collaborate with cross-functional leaders to develop and execute Chemistry, Manufacturing, and Controls (CMC) strategies for development projects from pre-clinical through late-stage clinical trialsDesign and implement integrated operational project plans that align with program milestones and regulatory requirementsMonitor project progress continuously and provide strategic updates to analytical department leadershipSupport resource planning and allocation through systems like RDPM to optimize program efficiencyDrive to completion any other assigned tasks and job dutiesAgile Project Management
Serve as Scrum Master to organize and facilitate project sprints, including backlog preparation, sprint planning, daily scrums, and retrospective sessionsApply project management best practices throughout the project lifecycle, from initiation through execution and closureFacilitate effective meetings by preparing agendas, capturing minutes, and driving action items to completionTechnical & Operational Support
Organize process support activities for mRNA teams at the Waltham facilityPartner with multidisciplinary teams to analyze and optimize analytical development approachesDrive continuous improvement in analytical operations and project delivery methodologiesRequired Qualifications
Education
Bachelor's degree in Analytical Chemistry, Biochemistry, Biotechnology, or equivalent field (Master's degree preferred)Experience
Bachelor's degree : Minimum 8 years of relevant project management experience in the pharmaceutical / vaccine industryMaster's degree : Minimum 5 years of relevant project management experience in the pharmaceutical / vaccine industryDemonstrated expertise in R&D or QC analytics within regulated environmentsProven track record managing analytical testing, stability studies, and method development / validation activities with external partners (CTLs / CDMOs)Technical Knowledge
Good understanding of physicochemical and biochemical analytical techniques, including :
UPLC / HPLC with UV detection, CAD, and MSCapillary electrophoresisSDS-PAGE and Western blottingColorimetric assaysDynamic Light Scattering (DLS) for particle size analysisAdditional analytical methodologies relevant to mRNA characterizationCore Competencies
Exceptional organizational skills with ability to manage multiple complex projects and priorities simultaneouslyOutstanding communication abilities (written and verbal) to effectively interface with internal teams and external partnersAgility and adaptability to thrive in a fast-paced, matrixed environmentStrategic thinking with the initiative to lead new initiatives and drive innovationProblem-solving mindset with ability to respond effectively to urgent requests and shifting prioritiesSoftware skills : Mastery of MS Office suite, Smartsheet, and / or other project management toolsFind Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.
Benefits
When you join Pace, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.
Equal Opportunity Employer
Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.