Associate Director, Engineering (Onsite)

Job Description

Title: Associate Director, Engineering

Job Description:

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 Biologics Pilot Plant (BPP) Process Operations Team.  We are recruiting a highly motivated and experienced person to Lead end-to-end program management for clinical manufacturing campaigns, with a focus on campaign preparation and closeout execution. The candidate will drive cross-functional alignment across Process Development, Quality, Supply Chain, and Manufacturing to ensure timely drug substance release, and oversee coordination of material transfer to downstream sites, ensuring readiness and alignment with clinical timelines. This candidate will work to identify and mitigate risks impacting delivery to proactively driving resolution across stakeholder groups.

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.

Key Responsibilities:

• Partner with the process leadership team 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

• Develop and implement a comprehensive training vision and strategy for Process Operations, aligned to BCMT and enterprise goals

• Design scalable onboarding frameworks to enable rapid ramp-up of new process engineers while maintaining compliance and quality standards

• Integrate innovative training approaches (e.g., prep sessions, digital content, external partnerships) to enhance learning effectiveness

• Champion a culture of accountability, collaboration, and continuous improvement

• Provide leadership oversight and approval for process-related Quality Notifications (QNs), Change Requests (CRs), and Standard Operating Procedures (SOPs)

• Ensure all process changes are technically sound, compliant, and aligned with long-term Process Operations strategy

Education Minimum Requirement:

BS or MS degree in Engineering or Biological Sciences with a minimum of 7 years of relevant experience within the Pharmaceutical or Biopharmaceutical industry.

Required Experience and Skills:

• 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 bioprocessing equipment

• Technical knowledge in purification processes such as chromatography, tangential flow filtration (TFF), and 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

• Understanding technical writing specifically for investigations and deviations

• Understanding of developing and leading a training program to support a GMP area

Preferred Experience and Skills:

• Excellent organizational and problem-solving abilit