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.
Competencies:
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.
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