Associate Director, Engineering

Merck•Upper Gwynedd Township, PA

1d•Onsite

About The Position

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough. Seeking a candidate for a leadership position in our Research & Development Division’s Biologics Pilot Plant (BPP) Process Operations Team. We are recruiting a highly motivated and experienced person to lead teams of process engineers in Bioprocess Clinical Manufacturing and Technology. This role will focus on two main elements: 1) Managing portions of on the floor manufacturing of large molecule clinical drug substance campaigns, inclusive of vaccines and biologics and 2) Managing overall program timelines for large molecule clinical drug substance campaigns coming in and out of the pilot plant. The ideal candidate will drive operational excellence, ensuring right-first-time (RFT) batch execution on the manufacturing floor, while providing technical oversight for operators. This will be balanced with ability to manage long end to end timelines and drive to drug substance deliverables for preparation, execution, and closeout of work. This position is based on-site, in a fast-paced and dynamic setting, requiring adaptability and quick thinking. In this position, you will exemplify our Company's leadership qualities by demonstrating integrity in all interactions, fostering a culture of innovation by encouraging creative solutions within your team, and embracing collaboration across functions to achieve common goals. You will hold yourself and your team accountable for delivering results, while also considering the long-term impacts of your decisions on our community and the environment. Additionally, you will champion diversity and inclusion by building a well-rounded team of subject matter experts, ensuring multiple perspectives contribute to our manufacturing processes.

Requirements

Bachelor's degree or Master's degree in Engineering or Biological Sciences with a minimum of 7 years of relevant experience within the Pharmaceutical or Biopharmaceutical industry.
A highly motivated individual with the ability to work in a fast-paced and dynamic environment
Demonstrated ability to mentor team members and influence cross-functional groups
Technical knowledge of fermentation and cell culture processes, including aseptic techniques, live virus handling, BSL2 practices, cleanroom protocols, and/or bioprocessing equipment
Technical knowledge in purification processes such as chromatography, tangential flow filtration (TFF), and/or dead-end filtration
Knowledge of the considerations required for transitioning from development to GMP (Good Manufacturing Practice) environments and influencing necessary adaptations
Strong understanding of cGMP (current Good Manufacturing Practices), quality systems, and safety protocols within operations
Hands on bioprocess experience either through labs or operations
Previous experience in leading projects in either process development or GMP environments
Adaptability
Biopharmaceutical Industry
Cell Cultures
Chemical Engineering
Data-Driven Decision Making
Fast-Paced Environments
Good Manufacturing Practices (GMP)
Mammalian Cell Culture
Manufacturing
Manufacturing Processes
Manufacturing Quality Control
Operational Excellence
Process Optimization
Safety Compliance
Safety Protocols
SAP Inventory Management
Strategic Thinking
Tangential Flow Filtration (TFF)
Technical Mentoring
Technical Writing

Nice To Haves

Excellent organizational and problem-solving abilities
Capability to work both independently and collaboratively, delivering strong results
Exceptional conflict management and negotiation skills
Strong communication skills paired with personnel development aptitude
Prior management experience, or experience leading teams
Experience with SAP inventory management system and/or SAP QN
Demonstration of Decision Making, Execution Excellence, Innovation, and Change Catalyst Leadership Skills

Responsibilities

Manage and mentor a team of process engineers specializing in bioprocess manufacturing for large molecules (vaccines and biologics).
Drive operational excellence for right-first-time (RFT) batch execution on the manufacturing floor.
Collaborate with cross-functional teams to ensure agile pipeline deliverables are met
Manage end to end timelines of clinical campaigns coming in and out of the pilot plant through preparation, execution, and close out