Director, Biologics Pilot Plant (BPP) Process Operations

Job Description

Job Description:

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 teams of process engineers in Bioprocess Clinical Manufacturing and Technology. This role will focus on managing on the floor manufacturing of large molecule clinical drug substance campaigns, inclusive of vaccines and biologics. The ideal candidate will drive operational excellence, ensuring right-first time (RFT) batch execution on the manufacturing floor, while providing technical oversight for operators. The candidate will need to have a deep technical understanding in either upstream and downstream unit operations across a wide variety of vaccine and biologics processes as well as the ability to translate technical understanding into hands-on operational aptitude on the manufacturing floor. While a deep understanding in upstream or downstream is sufficient, the candidate should have a general understanding of end-to-end bioprocessing. The candidate will also need to collaborate across the program teams with the ability to influence functional leadership. 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.

Key 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.

• Provide technical oversight and guidance to operators in bioprocess manufacturing environments.

• Identify and build subject matter experts (SMEs) within the team to support a well-qualified and well-rounded manufacturing team.

• Collaborate with cross-functional teams to ensure agile pipeline deliverables are met

• Work on efficiency initiatives that support increasing operational excellence

Education Minimum Requirement:

• BS or MS degree in Engineering or Biological Sciences with a minimum of 10 years of relevant experience within the Pharmaceutical or Biopharmaceutical industry. PhD 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 effectively

• Strong technical knowledge of fermentation and cell culture processes, including aseptic techniques, live virus handling, BSL2 practices, cleanroom protocols, and bioprocessing equipment

• Strong 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

• Proven leadership and project management skills to drive initiatives and team performance

• Hands on bioprocess experience either through labs or operations

• Previous experience in leading technical projects in either process development or GMP environments

Preferred Experience and Skills:

• Excellent organizational and problem-solving abilities

• Capability to work both independently and collaboratively, delivering strong results

• Exceptional conflict management and negotiation skills

• Ability to create and define a compelling vision, drive change, and influence decision-making within the organization

• Strong communication skills paired with personnel development aptit