Director, Manufacturing Operations

The Director, Manufacturing Operations will be responsible for establishing, managing and improving operational activities in support of the development of new products or processes with a primary focus on clinical and commercial supplies, within a pre-commercial biopharmaceutical company environment, build and leading a commercial contract manufacturing function for providing operational, technical, and tactical execution for drug substance/drug product manufacturing production events and campaigns.

Director, Manufacturing Operations Responsibilities:

• Delivering consistent GMP supplies through structured sponsor/CMO teams based on productive working relationships.
• Directly influence the build and management of contract manufacturing outsourcing supply strategy for gene therapy platform products built on retroviral replicating vectors, or RRVs, and small molecule pharmaceuticals initially for patients with recurrent high grade glioma (rHGG).
• Lead internal/external manufacturing site management.
• Ensure timely delivery of clinical and commercial manufacturing batch campaigns for drug substance and drug product (sterile and solid orals) as well as finish packaging
• Support process transfer and process engineering of retroviral replicating vectors (RRV) platform products including process optimization, new product implementation, process transfer, scale-up, validation, risk analysis, process characterization and troubleshooting.
• Cross functionally collaborate with Development, QA/QC, Regulatory, Supply Chain and Project Management functional areas to plan and implement the execution of cGMP activities in manufacturing operations for both developmental processes and commercial operations.
• In collaboration with Quality, directly and indirectly support development of the quality management system necessary to license, launch, and maintain commercial drug products to patients. Includes the generation, review and editing of procedures, policies, and training on standard practices necessary for clinical and commercial GMP supply chain.
• Drive key activities of post-filings, coordinating activities of multiple stakeholders, removing hurdles, and ensuring decisions are made in a timely manner.
• Support the design and implementation of Supply Chain and Purchasing necessary for GMP clinical and commercial supplies e.g. components, raw materials, disposables/single-use.
• Create and maintain validated processes, equipment, and components including single use disposable systems.
• Conduct and document appropriate risk assessments on manufacturing processes and mitigate concerns with actionable plans.
• In collaboration with supply chain management, develop tactical logistics plans for clinical manufacturing and commercial operations and execute against plan.
• Drive the identification, sharing and adaptation of best practices cross-functionally and between manufacturing sites with respect to process transfer, process monitoring, technical support and cleaning/mixing development.
• Ensure Quality Agreements are in place and CMOs are in compliance.
• Lead or support complex manufacturing related investigations/deviations to resolution and closure using root cause analysis tools and methodologies.
• Document findings and conclusions in a technical clear and compliant manner.
• Own, monitor, and report progress of projects within agreed upon time lines, ensuring customer and company objectives are met.
• Quickly address issues as they develop and leverage the appropriate technical expertise within the organization to resolve such issues.
• Partner with external manufacturing operational units and subject matter experts to ensure successful launch of RRV gene therapy products.
• Provide core launch team membership to due proactively plan and execute launch readiness activities with compliant quality product supply in a timely manner.
• Establish KPIs, necessary metrics, and reports to support process and performance improvement strategies.
• Support quality management monitoring, annual product reports, and other summary manufacturing data reviews as required to maintain product performance and licensure.
• Ensure operational related facilities comply with the highest level of cGMP compliance per FDA, MHRA and customer expectations.
• Ensure that all operations are compliant with EHS, OSHA, IATA, DOT and EPA requirements.
• Participate and represent manufacturing operations in client audits as required.
• Develop quality and business metrics for assessing productivity/profitability of manufacturing.
• Identify, select, contract and take part in managing suppliers that provide the critical raw materials or components (e.g. SUS, custom media) or services related to manufactured product.
• Lead cost savings and avoidance initiatives to ensure cost of goods goals are improved.
• Design, implement, and monitor supply risk mitigation strategies using standard tools.
• Lead as a change agent in fast-paced environment to promote flexibility, creativity, and accountability to ensure speed to market.
• Create an environment of teamwork, open communication, and sense of urgency.
• Ensures capital programs are implemented in accordance with process transfer and technical project plans and timelines.
• Support strategic direction for manufacturing resources and activities, and setting objectives to maximize the value of the organization's contributions by adapting new technologies, capabilities and providing educational opportunities for team members.
• Drive and maintain strong collaboration across the company and with external partners.
• Ensures compliance of manufacturing processes and department activities with national and international Government (e.g. FDA, EMEA, EPA, cGMP, CFR, Eudralex, and OSHA Safety) and Company Policies, Procedures, Goals and Objectives)
• Other duties as assigned.

Director, Manufactu ring Operations Skills and Experience :

• B.S. degree from an accredited institution in engineering and/or biological / pharmaceutical life sciences. Advanced degree a plus.
• Minimum of twelve (12) years relevant internal/external (CMO) experience in drug substance/drug product manufacturing and purification of virus, cell culture, and/or fermentation processes.
• Gene and/or cell therapy knowledge or operations experience is a strong plus.
• Five (5) years experience actively involved in process/product transfers
• Five (4) years experience with development and commercialization of sterile products
• Experience with regulatory accelerated biopharmaceutical programs (e.g. Breakthrough Strategy, Fast Track).
• Leadership and/or support launching a new commercial biopharmaceutical product.
• Broad experience in biopharmaceutical manufacturing with proven record of solving complex problems.
• Experience with biopharmaceutical GMP sourcing, supplier/CMO management or operations.
• Commercialization experience in fast-paced GMP startup, breakthrough designation product launch or similar drug launch environment very desirable.
• Strong influencing capabilities and ability to communicate effectively at all levels of the organization.
• Excellent verbal and written communication skills and confidence communicating with all staff levels.
• Knowledge of supply chain and sourcing, including de-risk strategies and contractual best practices.
• Process-oriented with strong analytical skills for risk identification and management.
• Strong analytical, problem-solving, and critical thinking skills.
• Experience negotiating and contracting key operational and/or supply chain partnerships.
• Interpersonal skills; good judgment and ethics; professional presence and demeanor
• Strong business orientation and financial skills
• Strong presentation skills as this role requires.
• Experience with development and commercialization of solid oral products a plus.
• Excellent skills with Microsoft Word, Excel, Power Point, and Project.
• Skilled in Lean Six Sigma tools and methodologies a strong plus
• Availability to travel (~20%)
• Knowledge about the biotechnology, virus, gene, and/or cell the manufacturing industry landscape, the key companies and their products/processes.
• Established network across the biopharmaceutical DS/DP outsourcing industry.
• Relevant certification and specialty training a plus (e.g. Six Sigma, PM, ASQ, APICS).