Senior Manager, Pharmaceutical Sciences

Shionogi Inc.•Florham Park, NJ

2d•$135,000 - $165,000•Hybrid

About The Position

The Senior Manager, Pharmaceutical Sciences applies broad pharmaceutical sciences and CMC expertise to develop and maintain commercial products that are safe, effective, compliant, and robust across the product lifecycle. This role will provide technical leadership for an oral suspension product and a sterile injectable product, including formulation/process development, technology transfer, external manufacturing (CDMO/CMO) oversight, investigations, and post-approval lifecycle management.

Requirements

Master’s Degree in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Polymer Science, or related discipline required; PhD preferred
8+ years of progressive pharmaceutical development experience (or equivalent), including formulation and process development through tech transfer and commercial support.
Demonstrated experience supporting oral liquid/suspension product and/or sterile injectable (aseptic processing/fill–finish and/or sterile filtration/terminal sterilization strategy)
Functions independently with minimal guidance while managing multiple, varied project responsibilities.
Must offer experience in pharmaceutical analysis, formulation development, and manufacturing scale up/technology transfer
Experience developing Validation Strategies for new products and processes.
Thorough knowledge of current GMPs (Good Manufacturing Practices)
Demonstrates expertise in ICH guidelines and regulatory authority requirements to ensure compliant pharmaceutical development, testing, documentation, and submissions
Thorough knowledge of functions and disciplines that contribute to the development, manufacturing, regulation and distribution of products intended for the pharmaceutical marketplace
Strong oral and written communication, including the ability to communicate to colleagues, business partners, stakeholders, and upper management
Ability to influence and coach positive behaviors within a matrixed organization as well as with the CMOs
Strong presentation skills
Strong analytical, critical reasoning, and problem-solving skills
Must be innovative, resourceful, proactive, and consistently effective
Adept at the use of word processors, spreadsheets, and other common software
Must be able to travel up to 40% - domestic and international
Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required 50% per month, at least 2-3 days per week.

Nice To Haves

Experience managing others in a matrix type environment is a plus

Responsibilities

Interact with external manufacturing partners and testing laboratories in support of management of development and tech transfer projects – clinical supplies, commercial and post-marketed products.
Participate in the development and review of validation strategies for new products and processes, including assessment of vendor change controls, risk assessments, annual product reports, and process validation protocols and reports.
Provide technical support for Supply Chain, Quality Assurance (QA) and Regulatory Affairs Departments, and Provide scientific direction and expertise to cross-functional teams.
Be responsible for Risk Management activities including risk assessment, impact analysis and Failure Modes and Effects Analysis (FMEA). Maintain working knowledge of available pharmaceutical technology in the marketplace and evaluate suitability for use with current or future development projects; as well as marketed products
Act as the Technical Lead and project manager on multidisciplinary development teams, maintaining responsibility and authority to make technical recommendations and managerial decisions that directly impact the project timeline and budget.
Participate in the selection of technology vendors and development partners.
Provide project updates (monthly reports, data summaries) to management.
Serve as the primary technical liaison to development laboratories and CMOs for key projects, and collaborate with Shionogi Japan colleagues on technology transfer activities while overseeing drug development and manufacturing processes.
Optimize design for manufacturing from cost reduction to line expansion capabilities.
Review IQ/OQ/PQ activities that are related to manufacturing processes.
Partner with manufacturing partners to identify process improvement needs and support the design and implementation of enhanced processes and practices.
Participate in due diligence CMC reviews for new business opportunities.
Participate in lab work in design and development of novel pharmaceutical dosage forms.