Director, Gene Therapy Manufacturing, Drug Su

We need to output HTML fragment with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. The posting includes description (About the role) and then "Key Responsibilities:" etc. Also "Requirements:" and "Preferred Qualifications". There's no explicit Benefits, Pay, Schedule sections. There's mention: "This position requires occasional weekend and shift work as well as on-call support. This position requires to be onsite full-time." That could be considered Schedule? It's about schedule: occasional weekend/shift work, on-call, onsite full-time. That is schedule info. So we can include a Schedule section with that content. Benefits not mentioned. Pay not mentioned. Skills maybe not separate; but we could include Skills if there is content like "Strong cross-functional leadership, communication, financial discipline, analytical thinking, problem-solving, and change-management skills." That's under Requirements. But we could put that under Skills section. However we need to avoid duplication. The instruction: Prefer a few substantive sections over many thin ones. So we could combine Requirements and Qualifications into one? But they ask to use headings for each if content exists. We have Requirements (Bachelor's degree, 10+ years etc). Preferred Qualifications (Master's degree preferred, etc). Could combine into Requirements and Qualifications sections. Skills maybe not needed separately if covered. But we could still include Skills if we extract skill statements. However that might be thin. Better to have sections: About the role (the introductory paragraph), Responsibilities (the bullet list under Key Responsibilities and sub-sections), Requirements (the bullet list after Requirements:), Qualifications (Preferred Qualifications), Schedule (the sentence about weekend/shift work and onsite). No Benefits, Pay. We must not repeat job title as heading. No Job ID. Remove boilerplate like EOE/MFDV (equal opportunity). So drop that line. We need to use

for section headings. Use

• for any list of duties/requirements/benefits. Use

  for prose. We need to preserve ALL substantive information; do not invent or summarize away detail. So we need to keep all details from the posting, but we can format them. Let's extract content. About the role: The first paragraph(s) before "Key Responsibilities:": "The Director, Gene Therapy Manufacturing, Drug Substance, provides leadership, hands-on technical and operational expertise to the manufacturing team. This role is accountable for leading and shaping the current and future manufacturing teams for our clinical and commercial drug substance manufacturing, including project and site readiness, organizational design, and the establishment of operating rhythms, accountability, governance, culture, and performance standards. The incumbent will lead tactical planning, cross-functional coordination, in collaboration with project management and MS&T, activities required for the continuous production of commercial product as well as successful site expansion and operational ramp-up. This is a key role in manufacturing operation that requires a highly dependable and disciplined leader with deep technical expertise in biological manufacturing unit operations (upstream and downstream), strong cGMP manufacturing knowledge, and proven operational leadership and people management skills." That's the About the role. Now Responsibilities: There's a heading "Key Responsibilities:" then sub-sections with bullet-like sentences. We need to capture all responsibilities. Let's list them: Manufacturing Operations Leadership - Build and enforce accountability and execution discipline across manufacturing teams. - Lead manufacturing teams in operations across production, quality, materials, and support functions. - Generate production schedules (for drug substance), requirements, quality standards, and ensure delivery commitments are met. - Direct responsibility of on the floor activities and resolving manufacturing issues on the floor, real-time. - Ensure manufacturing team is appropriately trained, qualified and documented to support safe and compliant operations. - Translate technical requirements into production plans, labor needs, material requirements, timelines, and deliverables. - Partner with MS&T and other functional groups in scale-up, technology transfer, implementation, and continuous improvement. - Other duties as assigned Production Planning and S&OP Support - Accountable for adherence to production schedule by ensuring production systems (equipment, batch records, etc.) are qualified, documented, monitored and ready for production. - Monitor labor, material, equipment, lead-time, and production risks to meet product demand. - Ensure readiness plans, risk assessments, and implementation plans are developed and executed effectively. - Other duties as assigned Quality, Safety, and Compliance - Promote and ensure production teams follow safety procedures, OSHA requirements, company policies, and work standards. - Partner with quality leadership to ensure processes meet internal standards, customer requirements, and applicable regulatory or certification requirements. - Ultimate responsibility of deviation management including, support corrective actions, root cause analysis, process control, documentation accuracy, and quality improvement. - Other duties as assigned Continuous Improvement and Lean Manufacturing - Lead and/or support continuous improvement across production, engineering operations, materials flow, and manufacturing workflows. - Apply Lean tools including 5S, Kaizen, root cause analysis, value stream mapping, visual management, standard work, and waste reduction. - Improve productivity, yield, quality, delivery, labor efficiency, and overall operational effectiveness. - Track KPIs such as on-time delivery, throughput, yield, downtime, rework, scrap, labor efficiency, and cost performance. - Optimize capacity, labor, resources, workflow, and priorities to improve throughput, quality, cost, and scalability. - Other duties as assigned Team Leadership and Development - Hire manufacturing operators, coach and develop managers and supervisors. - Strengthen communication and accountability across production, facilities, quality, supply chain, and leadership. - Support performance management, workforce planning, and leadership development. - Create a performance-driven culture focused on quality, execution, problem-solving, and continuous improvement. - Other duties as assigned Now Requirements: after "Requirements:" we have: - Bachelor’s degree in Biology, Chemistry, Chemical Engineering, or a related scientific/technical discipline. - 10+ years of relevant cGMP experience in biologics, pharmaceutical or other regulated manufacturing environments, with hands-on experience in production unit operations (upstream and/or downstream). - 5+ years of people leadership experience in one or more of the following areas: Manufacturing, Technical Operations, Quality Operations or Engineering. - Experience leading teams with direct and indirect reports. - Strong knowledge of cGMP, quality systems, regulatory readiness, and safety/environmental practices. - Demonstrated experience with operational planning, project leadership, or site ramp-up/start-up activities. - Proven ability to lead in complex environments and manage multiple priorities across functions with a sense of urgency. - Strong business acumen and experience with financial stewardship and resource planning. - Experience in deviation management, continuous improvement, and structured problem-solving tools. - Strong cross-functional leadership, communication, financial discipline, analytical thinking, problem-solving, and change-management skills. Now Preferred Qualifications: after "Preferred Qualifications" we have: - Master’s degree in Chemical Engineering , Operations, or related field preferred. - Engineering background with strong technical manufacturing experience preferred. - Experience with S&OP/SIOP processes and ERP/MRP platforms such as Oracle, SAP, NetSuite. - Lean Six Sigma or related certification preferred. - Experience with manufacturing systems improvement, supplier improvement, manufacturing strategy, cost reduction, and operational transformation. Now Schedule info: "This position requires occasional weekend and shift work as well as on-call support. This position requires to be onsite full-time." We need to put that in a Schedule section. Now we need to output HTML fragment with

  headings and

  • for lists. For prose we use

    . For the About the role we can put in

    . For each responsibility sub-section we could either make a

    but only

    allowed for section headings. The instruction: use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So only those specific headings. Within Responsibilities we could still use

    • for the list items, but we might want to keep subheadings? Not allowed to create other headings. So we could just list all responsibilities as a flat list, but we would lose the grouping. However we could keep the subheadings as plain text within
    • maybe? But that would be mixing. Better to keep the subheadings as part of the list item text (like "Manufacturing Operations Leadership: Build and enforce..."). We need to preserve ALL substantive information; we can include the subheadings as part of the list item text. Thus for Responsibilities we will have a
      with each responsibility bullet as
      • . Include the subheading as part of the text. Similarly for Requirements and Preferred Qualifications we will have
        • . For Schedule we will have

          with the two sentences. Now ensure we don't include boilerplate like "Other duties as assigned" maybe we should keep it as it's part of the posting. It's substantive? It's a placeholder but it's in the original. The instruction: "Preserve ALL substantive information; do NOT invent or summarize away detail." "Other duties as assigned" is not substantive but it's in the posting. Should we keep? It's not specific detail but it's part of the posting. I'd keep it to be safe. Now we need to ensure we don't create sections with filler like "commensurate with experience". Not applicable. Now output only HTML fragment. Let's craft:

          About the role

          The Director, Gene Therapy Manufacturing, Drug Substance, provides leadership, hands-on technical and operational expertise to the manufacturing team. This role is accountable for leading and shaping the current and future manufacturing teams for our clinical and commercial drug substance manufacturing, including project and site readiness, organizational design, and the establishment of operating rhythms, accountability, governance, culture, and performance standards. The incumbent will lead tactical planning, cross-functional coordination, in collaboration with project management and MS&T, activities required for the continuous production of commercial product as well as successful site expansion and operational ramp-up. This is a key role in manufacturing operation that requires a highly dependable and disciplined leader with deep technical expertise in biological manufacturing unit operations (upstream and downstream), strong cGMP manufacturing knowledge, and proven operational leadership and people management skills.

          Responsibilities

          • Manufacturing Operations Leadership: Build and enforce accountability and execution discipline across manufacturing teams.
          • Manufacturing Operations Leadership: Lead manufacturing teams in operations across production, quality, materials, and support functions.
          • Manufacturing Operations Leadership: Generate production schedules (for drug substance), requirements, quality standards, and ensure delivery commitments are met.
          • Manufacturing Operations Leadership: Direct responsibility of on the floor activities and resolving manufacturing issues on the floor, real-time.
          • Manufacturing Operations Leadership: Ensure manufacturing team is appropriately trained, qualified and documented to support safe and compliant operations.
          • Manufacturing Operations Leadership: Translate technical requirements into production plans, labor needs, material requirements, timelines, and deliverables.
          • Manufacturing Operations Leadership: Partner with MS&T and other functional groups in scale-up, technology transfer, implementation, and continuous improvement.
          • Manufacturing Operations Leadership: Other duties as assigned
          • Production Planning and S&OP Support: Accountable for adherence to production schedule by ensuring production systems (equipment, batch records, etc.) are qualified, documented, monitored and ready for production.
          • Production Planning and S&OP Support: Monitor labor, material, equipment, lead-time, and production risks to meet product demand.
          • Production Planning and S&OP Support: Ensure readiness plans, risk assessments, and implementation plans are developed and executed effectively.
          • Production Planning and S&OP Support: Other duties as assigned
          • Quality, Safety, and Compliance: Promote and ensure production teams follow safety procedures, OSHA requirements, company policies, and work standards.
          • Quality, Safety, and Compliance: Partner with quality leadership to ensure processes meet internal standards, customer requirements, and applicable regulatory or certification requirements.