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Description
Locations include: New Brunswick NJ, Saint Joseph, MO or Duluth, GA.
Duties & Responsibilities
- Be the "go to" technical expert for Global MSAT and Operations leadership for BIAH products and processes for analysis and guidance throughout product / process lifecycle
- Provide guidance and influence decisions on new technologies to support future definition of innovative manufacturing platforms
- Lead development, maintenance and advancement of technical body of knowledge for BIAH products and processes
- Execute independent technical deliverables and projects and appropriately sized cross-functional technical projects as Project Leader, Stream Leader, Project Contributor or Program Leader
Locations include: New Brunswick NJ, Saint Joseph, MO or Duluth, GA.
Duties & Responsibilities
- Be the "go to" technical expert for Global MSAT and Operations leadership for BIAH products and processes for analysis and guidance throughout product / process method lifecycle
- Responsibilities include:
- Provide technical guidance for change requests autonomously
- Analyze complex process / product data to a higher-order and prepare reports autonomously for decision making
- Provide technical leadership, guidance and influence on processes and strategies for troubleshooting, root cause analysis and execution of technical transfer, manufacturing deviations, validations, analytical tests, etc.
- Provide technical leadership and guidance for questions received from Regulatory Authorities in various regulatory processes, e.g. geographical expansion of existing products, post approval changes on existing registrations.
- Lead strategy development and deployment of technical solutions for process optimization/ improvement of analytical test methods with possible impact on cost of goods
- Provide guidance and influence decisions on new technologies to support future definition of innovative manufacturing platforms
- Responsibilities include:
- Lead scientific exploration on existing BIAH technologies to guide definition of Technology Standards
- Authoring of technical Position Papers for MSAT Organization
- Recommend and advocate "as expert voice" for on new technologies for potential use in existing or new manufacturing processes
- Recommend and advocate "as expert voice" for future-oriented Technology Platforms
- Lead development, maintenance and advancement of technical body of knowledge for BIAH products and processes
- Responsibilities include:
- Continually develop and maintain an appropriate individual level of theoretical and practical expertise to respond to the needs of BIAH
- Lead MSAT mentorship program and mentor MSAT experts in experiential technical and transferrable knowledge growth
- Lead exchange program of Technology expertise across global and local MSAT teams
- Participate as active and influential member of industry working groups representing BIAH
- Lead and advance product / process knowledge within global and local MSAT teams
- Execute independent technical deliverables and projects and appropriately sized cross-functional technical projects as Project Leader, Stream Leader, Project Contributor or Program Leader
- Responsibilities include:
- Operations Lead (by topic) of CMC Development sub-team
- Technical guidance and recommendation for user requirements, product or process changes
- Develop, structure and lead cross-functional streams / projects / programs aligned with project management methodology
- Propose and manage scope, budget, schedule, and associated risks to deliver fully-functional deliverables / projects meeting Customer requirements
- Ensure compliance to regulatory requirements and BI / external standards (EHS, VICH, Corporate procedures, GxP etc.)
- Establish & maintain communication tools (e.g. project charter, monthly reports) to effectively communicate with all relevant stakeholders
- Ensure and measure customer satisfaction along the project lifecycle
- Ph.D. from an accredited institution in scientific discipline (Pharmacy, Chemistry, Biochemistry, Biological sciences preferred) with a minimum of five (5) years of direct industry experience; Or
- Masters degree from an accredited institution in scientific discipline (Pharmacy, Chemistry, Biochemistry, Biological sciences preferred) with a minimum of ten (10) years of direct industry experience; Or
- Bachelor's degree from an accredited institution in scientific discipline (Pharmacy, Chemistry, Biochemistry, Biological sciences preferred) with a minimum of fourteen (14) years of direct industry experience
- Experience must be inclusive of at least three (3) years of experience leading, influencing and developing people across the organization
- Additional qualification in Business (Supply Chain, Economics) preferred
- Professional Certification in Scientific field or Project Management preferred
- Expertise in novel technologies or sciences is an advantage
- Specialized depth of knowledge and extensive industry experience in one or more of the following areas: manufacturing sciences, manufacturing engineering, product formulation, material science and analytical testing methodologies of pharmaceuticals or biologicals products
- Thorough understanding and process knowledge of Pharmaceutical Quality System within BIAH
- Thorough understanding and technical application of Good Manufacturing Practice (GMP) regulations and regulatory guidance for industry
- Technical "how to" guidance, application and approach influence on data & information for CMC, product manufacture & delivery (e.g. manufacturing processes, quality, supply chain & risk management)
- Thorough understanding and influence on new product development and product lifecycle management processes
- Leading AH Global Supply User Requirements driving effective and achievable AHGI deliverables
- Responsible and accountable for communication of technical information for varied audiences
- Demonstrated leadership, influence, and people development in international/intercultural collaboration
- Experience and leadership in Agile Management preferred
- Demonstrated leadership and influence through communications and truly engaging diverse audiences, within and cross organizations and from individual contributor to leadership levels
- Proven and demonstrated specialized/depth of knowledge and leadership in identified discipline
- Proven leadership and mentoring of Experts and influence on peers
- Fluency in English required - additional language skills are an asset
- Willingness to travel domestically and internationally