Senior Manager of Process Development – Houston
This position manages and directs all work activities for Process Development laboratory and client related projects in the process development department. Supervises daily and routine lab duties to ensure that client requirements are met, and company profits are considered. Maintains the process development laboratory within the requirements of the company’s standard regulations. Maintains appropriate documentation for PD projects.
Owns the development lifecycle for multiple projects in parallel; provides technical direction to the project leads and manages technical risks throughout the development and technology transfer process ensuring successful program delivery. Drives scope definition and experimental design of development activities (process development and bioassay) through respective project leaders, aligns goals of the project with MSAT and manufacturing, obtains buy-in from client and removes obstacles to successful completion.
- Maintains constant emphasis on safety and ensures a safe working environment for self and others.
- Leads a team of ~ 4 to 10 Research Associates and Scientists for the development of processes for contract cell manufacturing.
- Owns the development lifecycle for multiple projects in parallel; provides technical direction to the project leads and manages technical risks throughout the development and technology transfer process ensuring successful program delivery. Drives scope definition and experimental design of development activities (process development and bioassay) through respective project leaders, aligns goals of the project with MSAT and manufacturing, obtains buy-in from client and removes obstacles to successful completion.
- Establishes and executes the detailed development project plan including PD and Bioassay activities from process / assay transfer, optimization, qualification, and tech transfer. Working with the PM, engages supporting departments proactively and manages changes to scope and timeline effectively. Actively drives alignment with MSAT and Mfg on process development targets to ensure appropriate process fit and success in manufacturing.
- Keeps project manager updated on progress and challenges, and serves as liaison between development staff and other departments.
- Manages team resources using established systems and ensures close collaboration with other PD managers to support cross-training, dynamic resource management and seamless delivery of department goals.
- Serves as technical SME in client/regulatory audits, supports proposal development for existing and prospective clients in conjunction with sales and business development.
- Develop and mentor direct reports through challenging assignments and providing constructive feedback, goal setting and monitoring performance on a routine basis (via formal and informal channels), and ensuring that overall project goals are on track.
- Fosters a positive and collaborative work environment across the department and site; supports, communicates and manages change driven from within and outside the department effectively. Encourages open communication.
- Supports the Development, Operations, and Site management to implement standard processes and new initiatives that helps addressing quality, safety, and operations challenges.
- Develops and maintains strong client connections founded on technical leadership, strong execution and solid communication.
- Continually seeks opportunities to improve client satisfaction while keeping the company’s interests in clear focus.
- Supervises process development labs directly or through team to ensure that they are fully capable, operationally efficient and safe. Pays specific attention to cleaning, safety, 5S and EPS compliance.
- Proactively and independently works with other managers and department heads to resolve conflicts or gain alignment prior to escalation.
- Owns and drives the implementation of standard work and global best practices
- Identifies and escalates process risks, prepares project progress summaries appropriate for management / client review. Prepares and reviews presentations, protocols, and PD reports.
- Develops and implements departmental SOP’s, DMR’s, labels, PQA documents, written materials. Understand at-scale cGMP manufacturing process and constraints to develop principles for process development in the lab and successful transfer.
- Develops strong connections within the company network, contributes proactively to global projects and is known as an industry expert in area of specialty.
- Focuses on increasing the company’s presence in the Cell Therapy industry through conference presentations, seminars.
- Master’s Degree with 8-10 years or Ph.D. in a life science discipline with 4-7 years of post-graduate experience with bioprocessing applications and / or cell therapy related topics.
- Extensive experience with development of bioreactor protocols, scale up, and development of different cell culture platform technologies
- Strong desire developing new products and service offerings for the cell therapy market.
- Solid knowledge and understanding of current cells therapy applications
- Substantial interest in preparing service proposals for potential customers and managing a service portfolio.
- Multiple years of previous supervisory experience with strong team leadership and interpersonal skills.
- Experience in working with clients and managing customer projects.
- Strong track record of translating new product ideas into project plans and executing them by assigning resources as well as tracking project progress toward milestones and deadlines.
This global organization is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. They harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life. Not only are they a custom manufacturer and developer, this company also offers services and a wide range of products to include active pharmaceutical ingredients, stem-cell therapies, organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria, and other pathogens. The company invests in quality workforce and the culture encourages the employees to challenge themselves and offer a work environment that fosters creativity and success. They have extensive benefits, competitive compensation, and opportunities for advancement.