Senior Scientist, Engineering- Lab Start-Up and Commercialization
PharmaBiotechRegulatory AffairsQuality Assurancegmpregulatory submissionemacroraveinform
Job description
Job Description Join Our Team as a Biologics Conjugation Senior Scientist! We are seeking a strategic and technical scientist with expertise in laboratory start up and operations ideally in a development & commercialization space to support our ever growing and dynamic late-stage biologics pipeline within the expansive Biologics S&T portfolio. Why You'll Love This Role: As a Sr. Scientist in Biologics Conjugation Commercialization, you’ll be at the forefront of starting up new lab capabilities for conjugation. Setting up systems and processes to help the lab operate efficiently and effectively. As the laboratory manager, you will troubleshoot and solve problems for the laboratory and operating systems, and help drive capital planning processes and asset management programs. A key deliverable of our commercialization team is to have qualified scale down models for our conjugation processes, and you will be instrumental in design and establishment of those models to support process characterization, right first time PPQ and regulatory filings. You will engage our program team members to understand their needs and continually look to improve operations by developing efficient solutions that will support business objectives and ensure continuity and Safety, and Environmental compliance. Key Responsibilities: Scientific Engagement: Help the Biologics Conjugation Commercialization team with scientific direction and consistent establishment of lab scale down models to be used across our portfolio. Lab Operations Leadership: Lead daily lab operations, including scheduling, training, inventory management, tiers and operational metrics to enable efficient experimental execution and continuous improvement. Asset Reliability and Capability Leadership: Lead capital asset startup, equipment ownership, project planning, maintenance, calibration, troubleshooting, and root cause failure analysis to ensure laboratory equipment and systems remain reliable, accurate, efficient, and ready for use. Compliance, Safety, and Process Safety Leadership: Ensure laboratory activities, systems, and equipment are maintained in compliance with safety, environmental, quality, regulatory, and Process Safety Management requirements, including appropriate controls for work involving potent compounds. Cross-Functional Collaboration: Unite diverse teams to achieve program goals as One Team. Champion compliance and safety; promote a culture of diversity, inclusion, and equity. Experience and aptitude to work, and collaborate in internal and external cross-functional, matrixed teams. Project Management: Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment. Recognition: Celebrate team achievements and foster a culture of appreciation. Innovation: Lead business improvement initiatives and leverage your network to drive change. Education & Experience: Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of relevant industry experience. OR Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with four (4) years of relevant industry experience. OR Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with a no minimum relevant knowledge. What You Bring: Ability to lead without authority, build trust, and inspire accountability Ethical, resilient, and committed to excellence Skilled in risk management, team facilitation, and strategic planning Exceptional communication and stakeholder engagement skills Sound judgment and issue-resolution mindset, Ability to navigate ambiguity, remove barriers, and escalate appropriately to keep work moving. Preferred Skills : Laboratory start-up experience In-depth knowledge of conjugation chemistry techniques. Experience working in laboratories that handle potent compounds, high-containment materials, or specialized safety controls. Experience in pilot or commercial scale manufacturing of biological molecules. Familiarity with late-stage process development, process characterization, scale down model qualification, process validation regulatory submissions, and working with external contract organizations. Minimum of 3 years experience troubleshooting equipment and utility systems Minimum of 3 years experience executing/supporting Capital projects/Project Management Understanding of or experience with Capital and Profit Planning Processe Experience with Computerized Maintenance Management System (CMMS) software such as SAP, Procal, or Maximo Experience in using QlikSense, Spotfire, or other data analytical software Experience in performing root cause analysis Required Skills: Antibody Drug Conjugates (ADC), Bioconjugation, Bioreactors, Capital Planning, Capital Project Management, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Clinical Judgment, Conjugation Chemistry, Design of Experiments (DOE), Detail-Oriented, Good Manufacturing Practices (GMP), Influencing Without Authority, Laboratory Operations, Laboratory Setup, Leadership, Process Design, Process Optimization, Process Scale Up, Project Development, Project Management, Project Resource Management, Root Cause Investigations, Technology Transfer 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 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 Rights
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