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Senior Manager Of Process Engineering (PE) In Manufacturing Technical Services (MTS)

The Senior Manager of Process Engineering (PE) in Manufacturing Technical Services (MTS) will manage the MTS PE's and be responsible for managing the strategy of MTS PE projects. Such activities as reviewing protocols, reports, and investigations generated by the MTS PE's will be an essential function of the MTS PE Sr Manager. The Senior Manager will 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 to support the QE group in creating and maintaining the DHF and risk documents. The Senior Manager will present important technical / metric-based data to the executive team representing MTS 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 (CPP's), 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 successful commercial manufacture of quality product for the lifecycle of the product. The Senior Manager will be responsible for complex process or product investigations that arise in commercial manufacture and complex or high priority raw material or equipment qualifications.

The Senior Manager of PE 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 PE's in the group. The Senior Manager of PE will also be responsible for leadership of the MTS PE's in the qualification of equipment, 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 PE 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 equipment and 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 PE's in MTS.
• Use leadership and strategic thinking to develop the PE's through cross-training and guidance.
• Improve procedures to attain or maintain best practices considering compliance, cost effectiveness, and efficiency.
• Represent and report data to executive 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 MTS in Core Development Teams where a product is being prepared for commercialization or site transfer.
• Must be able to troubleshoot manufacturing and process related excursions as the technical expert for commercialized product.
• 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 PE 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.

Qualifications

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 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.