Sr Manager Process Development at Noven Pharmaceuticals

Miami, Florida, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Jan, 26

Salary

0.0

Posted On

17 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Leadership Skills, Project Management, Statistical Tools, Process Development, Regulatory Understanding, Cost Analysis, Technical Expertise, Process Improvement, Cross-Functional Collaboration, Quality By Design, Design Of Experiments, Risk Assessment, Communication Skills, Problem Solving, Team Management, Innovation

Industry

Pharmaceutical Manufacturing

Description

Overview The Senior Manager of Process Development (PD) in Research and Development (R&D) will manage the R&D Development Engineers (DEs) and will be responsible for managing the strategy of R&D DE projects. The main scope of the Process Development Department will include process scale-up, materials purchasing coordination with procurement for scale-up activities, materials qualifications, manufacturing support, and process improvements. Other activities such as maintenance and inventory of controlled substances, product transfers, Design History File (DHF) support and cross functional activities with the Pharmaceutics team will occasionally occur. Some of the specific responsibilities for this position include reviewing protocols, reports, and investigations generated by the R&D DEs. The Senior Manager will be responsible for all strategies involving process scale-up, materials qualifications, and process improvements. The Senior Manager should have a strong understanding of cost analysis being able to justify capital or expense inventory reserves cost to justify the importance of projects. The Senior Manager must have a strong and broad regulatory understanding to plan the most effective project strategies and ensure first pass approvals on regulatory submissions. The Senior manager will be responsible for delegating and controlling timelines for all projects. The Senior Manager role is a working manager role with high profile and urgent project sometimes being assigned to the Senior Manager. The Senior Manager will also serve as the key technical liaison and project lead for technical transfers of products between product development and operations for new products moving into manufacturing and from commercial process to commercial process in external transfers. The Senior Manager will be responsible for supporting the QE group in creating and maintaining the DHF and risk documents. The Senior Manager will present important technical/metric-based data to leadership teams representing R&D independently. The Senior Manager will be the technical product/process Subject Matter Expert (SME) and thoroughly understand product quality by design (QbD) elements such as quality target product profile (QTPP), critical quality attributes (CQA’s), critical material attributes (CMA’s), critical process parameters (CPPs), and product and process risk assessments. The Senior Manager will have oversight of design and pre-launch development activity in addition to owning the transfer of new products. The Senior Manager will be expected to understand the general chemical and physical interactions of the product and how process variation affects product quality. The Senior Manager will support verification of early-stage commercial process performance and process investigation through design of experiment (DOE) and other statistical tools. The Senior Manager is responsible for the transfer of knowledge to the operations department to ensure a successful commercial manufacture of quality products for the lifecycle of the product. The Senior Manager will be responsible for complex process or product investigations that arise in commercial manufacturing and complex or high priority raw material qualifications. The Senior Manager of PD is a working manager and will be expected to project manage and complete tasks for complex or high priority projects as well as oversee the project management of other DEs in the group. The Senior Manager of PD will also be responsible for leadership of the R&D DEs in the qualification of processes and new raw materials, as well as creating value improvement projects that will reduce costs or cycle times in commercial manufacturing. The Senior Manager of PD will also assist the operations team in process monitoring and provide them tools to make process monitoring more continuous and effective at avoiding defects and reducing cycle times. Responsibilities Understand and delegate PE projects such as process qualifications, material qualifications, raw material and commercial product shelf-life extensions, process/product investigations, process improvements, capital projects, and design of experiments to support commercial operations. Work with the CMC Regulatory group to develop risk based regulatory strategies for process and material qualifications. Manage administrative tasks of the DEs in R&D. Use leadership and strategic thinking to develop the DEs through cross-training and guidance. Improve procedures to attain or maintain best practices considering compliance, cost effectiveness, and efficiency. Represent and report data to leadership teams. Interface as a liaison between partners of all internal departments relative to product development or site transfer projects/products to optimize technology transfer. Representative for R&D in Core Development Teams where a product is being prepared for clinical studies, commercialization or site transfer. Must be able to troubleshoot manufacturing and process related excursions as the technical expert for commercialized products. Must be able to lead, execute, and analyze DOE studies. Must be able to use statistical tools to provide acceptance criteria for protocols, qualifications, and process performance. Make strategic decisions for the PD group independently. Coordinate operator training for new processes or improvements. Must be able to use data to solve problems including but not limited to raw material or chemical interactions and process variation. Draft and revise functional protocols, reports and SOPs. Serve as liaison between Operations and other internal departments to ensure overall compliance with GMP & FDA requirements in the execution and development of projects coming to manufacturing. Support QE group in the generation and maintenance of DHF and risk documents. Promote “team” atmosphere between all functional departments as well as cross-functional teams with corporate partners. Support product launches and tasks involved related to operations deliverables. Take initiative to identify innovative technology that will improve the quality and cost of products. Conceptualize, design, and implement process analytical technology (PAT) to reduce manufacturing cost and defects and reduce cycle times. Oversee/support engineering and vendor design of critical equipment to ensure control of critical aspects and parameters. Work with production planning, operators, and product release to complete qualifications on time and according to regulatory requirements. Advise R&D during product/process design and re-design in an effort to reduce costs to optimize technology transfer. Develop protocols, reports, batch records, procedures, critical process parameter justifications, and risk assessments to ensure successful project execution. Analyze data and generate reports and/or presentations in assessing process performance. Support process risk assessment, design, scale-up, process improvement, and validation readiness of formulation operations. Provide operational oversight to ensure that experimental execution and process technology transfers are delivered with first time quality. Provide technical support for problems and projects related to pilot through full scale commercial manufacturing operations. Support an innovative effort to identify, evaluate, and implement new technologies that will improve the quality and cost efficiency of manufacturing processes. Serve as a cross-functional team member to support internal and external projects to include process development for non-commercial and commercial products. Represent the department during partner, FDA, and other governmental audits. Qualifications Competencies: Leadership skills such as communication, decision making, project management, ability to earn trust of co-workers, strategic thinking, and ability to manage multiple projects/resources at a given time. Broad technical ability including mechanical, biomedical and chemical engineering skill sets or experience. Ability to quickly learn complex chemical or physical interactions of product ingredients and mechanical processes. Strong initiative to learn, challenge existing states when appropriate, initiate projects of improvement, persuasively communicate projects with promising financial returns, and communicate across departments and functions facilitating successful product transfer. Ability to manage a team that will execute and deliver conclusive results with recommended actions based on those results. Passion for pharmaceutical development and market supply through commercialization. Self-expectation to establish a new standard of excellence for the position and department. Resolve to push back on products / projects that do not meet the requirements of a successful transfer to manufacturing. Strong project management skills to ensure that multiple projects stay on task and deliver results timely. Education & Experience: Bachelor’s degree in Chemical or Biomedical Engineering preferred or bachelor’s degree in Engineering with relevant pharmaceutical process experience. Four years or more, professional experience in a regulated environment or Advanced Degree with appropriate experience. Knowledge of transdermal pharmaceuticals and manufacturing a plus. Candidates with a background of polymer science or manufacturing, coating/drying, or polymer film manufacturing will also be strongly considered. Statistical DOE and product transfer experience is preferred. Project management credentials and/or experience is preferred. Excellent written and verbal communication skills; able to establish and maintain professional relationships. Keen attention to detail. Experience with domestic (FDA) and/or international health authorities' (MCA, IMB, JP, EU, etc.) regulations, GMP and ISO guidelines desired. Work Environment: Air-conditioned office environment. Approximately 75% of time spent sitting at desk, operating a computer, talking on the phone and attending meetings. Approximately 25% of the time spent on the manufacturing floor overseeing DOE’s Priorities often shifting, with frequent interruptions and tight deadlines; extra hours occasionally required. Physical Demands: Occasionally required to stand for more than two hours at a time. Occasionally lift and carry objects weighing up to twenty pounds. Visual acuity and manual dexterity required to perform experiments, operate computer and proofread documents.

Responsibilities

The Senior Manager of Process Development will manage R&D Development Engineers and oversee the strategy of R&D DE projects, focusing on process scale-up, materials qualifications, and process improvements. They will also serve as the key technical liaison for product transfers and ensure compliance with regulatory submissions.