Associate Scientist Biologics Drug Substance Commercialization Analytics Lab Lead

We are seeking a strategic and technical scientist with expertise in process analytics development & commercialization space to support our ever growing and dynamic late-stage biologics pipeline within the expansive Biologics S&T portfolio.

As an Associate Scientist in Biologics Process Analytics Commercialization, you'll be at the forefront of supporting a rich robust pipeline by delivering analytic insights to process stakeholders.

As the laboratory lead, you will troubleshoot and solve problems for the laboratory and operating systems, applying technical skills to bring in new assays in our non-GMP laboratory. In addition, you will lead a small team with the goals of maintaining a high performing team, with focuses on data integrity, quality and meeting desired turnaround times. You will also work with internal and external partners to provide reliable and efficient laboratory operations.

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.

• Team Leadership
  :
  Lead the day-to-day scoping and prioritization for testing of non-GMP analytical samples, for a team of non-Company employees. Appropriately communicate and delegate to team members to ensure program deliverables are met and resource allocations are managed appropriately
• Lab Operations Leadership
  :
  Working closely with lead of non-Company employees, the lab lead will oversee daily lab operations, lab tier, lab preparation, scheduling, training, inventory management, and operational metrics to enable efficient experimental execution and continuous improvement. Lead establishment of new assays and new molecules for the team.
• Reliability and Capability Improvement
  :
  Resolve equipment and system issues, reduce downtime and excessive maintenance or energy use, and partner with vendors and internal stakeholders to enable capability enhancements.
• 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.
• Cross-Functional Collaboration
  :
  Unite diverse teams to achieve program goals as One Team. Collaborate with counterpart in NJ to ensure alignment across teams. 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.
• Documentation
  :
  Maintain high-quality documentation practices compliant with ALCOA principles. Author and/or review technical documents including development reports, analytical test protocols, laboratory procedures, comparability protocols, etc.
• Communication
  :
  Excellent interpersonal and communication skills
• 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.

• B.S in Analytical Sciences/ Chemistry/ Chemical Engineering/ Biochemistry or related field

• Experience with HPLC/UPLC/capillary electrophoresis executions and data analysis of therapeutic proteins using various techniques such as IEX, SEC, HIC.
• Experience with Empower software.
• Leadership skills and ability to manage the daily tasks of a small team of analysts.
• Ability to perform benchtop laboratory operations.
• Demonstrated ability to plan, execute, optimize, and troubleshoot analytical assays.
• Outstanding communication (oral and written), organization and time management skills; ability to work independently and collaboratively.
• Motivation to learn new skills, willingness to take on new challenges, and scientific curiosity.
• Experience in using Power BI, Spotfire, or other data analytical software.
• Ability to work independently and as part of a team, self-motivator, positive attitude, and proactive problem solver.
• Ability to foster a collaborative working environment.
• Adaptability and capability to respond to changing needs.
• Strong attention to detail and quick learner.
• Demonstrate ability and/or aptitude in…