Manager, Analytical Sciences & Technology-00000U2X
Description
Janssen Supply Group, LLC is recruiting for a Manager, Analytical Sciences & Technology. The position will be primarily located in Raritan, NJ; Titusville, NJ; Spring House, PA; Malvern, PA; Horsham, PA; Gurabo, PR; Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Latina, Italy; or Schaffhausen, Switzerland.
Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
The Manager, Analytical Sciences & Technology (AS&T) position provides subject matter expertise in; Physical Test Methods, Quality by Design (QbD), Continued Process Verification (CPV), and Process Analytical Technology (PAT) technologies and infrastructure. It provides Quality Assurance & Quality Engineering leadership for development, qualification, validation and transfer of new physical and analytical methods; Leadership and guidance for Process Characterization and Process Validation for Medical Devices, Drugs, or Combination Products, ensuring compliance to regulatory requirements; and Quality Assurance & Quality Engineering leadership for pipeline and legacy combination products, inspection processes and manufacturing activities. The Manager, AS&T performs planned projects and investigations in support of manufacturing facilities and release laboratories, and uses quality principles and tools to develop and optimize quality systems, manufacturing processes, and product designs, etc. The individual works on problems of diverse scope with the ability to apply statistical and analytical skills appropriately.
The Manager, Analytical Sciences & Technology PQM applies subject matter expertise in QbD, Continued Process Verification (CPV), Process Validation (Device, Drug, Combination Products) and PAT technologies and infrastructure. Ensures development, qualification, validation and transfer of new physical and analytical methods. Performs and documents planned projects and investigations in support of Pilot, Manufacturing Facilities and Release Laboratories to advance proactive and real-time quality principles and practices. The Manager has accountability for promoting the application of Risk, Quality and QbD principles to enhance methods development, product knowledge and process understanding with the aim of continuously improving product and process performance. This position drives innovative thinking along with a disciplined approach for the rapid, compliant, high quality development and transfer of advanced physical and analytical methods to multiple plant locations while ensuring business and regulatory requirements are achieved. This position is responsible for adhering to environmental and safety policy and procedures and supports department environmental and safety objectives.
The Manager, Analytical Sciences & Technology is responsible for ensuring Janssen has adequate core knowledge and bench strength in quality assurance and quality engineering for Analytical Sciences & Technology, applying subject matter expertise in Design Controls, QbD, CPV, and PAT technologies and infrastructure. The individual is accountable to ensure the organization complies with Design Controls and other GxP and Quality System related activities, including, Design History Files and related documentation. This includes creating new quality frameworks for emerging and advanced physical and analytical methods and technologies. He/she is responsible for Quality Assurance & Quality Engineering leadership and support for development, qualification, validation and transfer of new physical and analytical methods, with appropriate application of statistical and analytical skills. He/she provides strategic development and successful execution of quality assurance and quality engineering. Leads, guides and supports Process Characterization and Process Validation for Medical Devices or Combination Products, ensuring compliance to regulatory requirements. Provides Quality Assurance & Quality Engineering leadership for pipeline and legacy combination products inspection processes and manufacturing activities. The Manager plans and manages multiple projects concurrently, and performs investigations in support of manufacturing facilities and release laboratories, applying quality principles and tools to develop and optimize quality systems, manufacturing processes, and product designs, etc., effectively documenting and presenting status updates, and writing and reviewing quality procedures and protocols. The individual is responsible for ensuring personal and company compliance with all federal, state, local, and company regulations, policies, and procedures for health, safety, and environmental compliance. The role drives continuous improvement throughout department to ensure most efficient use of resources to deliver value-added support; Establishes and maintains best practices, ideas and methodologies; Leads and motivates the performance of assigned staff, provides performance feedback along with development plans to enable top performance. Collaborates with all stakeholders and business partners to meet goals and objectives, identify opportunities and drive projects forward. Builds networks to maintain trust. The Manager plans and budgets department needs to ensure delivery on commitments and maintain adequate compliance, including projects related to continuous improvement of quality systems. He/she participates in J&J and Pharma sector initiatives related to device, combination product and emerging technologies product development and Quality Systems and other related duties as assigned by management.
Qualifications
A Bachelor’s Degreewith 9+ years related experience OR a Master’s degree with 7+ years experienceOR a PhD with 5+ years related experience is required. A degree in Chemistry, Biology, Engineeringor other scientific discipline is preferred. Experience with Quality Systems, ISO 13485, ISO 14971, EN 62366, cGMP,and/or ICH Requirements is required. Knowledgeof Devices, Biotech and/or Pharma Manufacturing required, particularly intechnology transfer/design transfer, Design Controls and/or Risk Management. Strongstatistical skills are required. Experiencein the development, qualification, validation and transfer of new physicaland/or analytical test methods is required. Experience in the development, qualification, validation and/or transferof Process Analytical Technology (PAT) systems is required. Black Belt or Master Black Belt preferred. FPX Certified preferred.
Demonstrated strongpeople leadership and management skills are required. Prior leadership of and participation in projectsacross departments is required. StrongProject Management skills required. Strong Communication, Conflict Management, Facilitation and DecisionMaking skills are required. Excellenttechnical writing skills; experienced in SOPs, protocols, reports required. Working knowledge of Statistical Methods /Processes required.
Approximately 25%travel, domestic and international is required for this role (possibly moredepending on the individual’s location).
BE VITAL in yourcareer. Be seen for the talent you bringto your work. Explore opportunitieswithin the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-New Jersey-Raritan
Other Locations:North America-United States-Pennsylvania-Malvern, North America-United States-Pennsylvania-Horsham, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, North America-United States-Pennsylvania-Spring House, North America-United States-Puerto Rico-Gurabo, Europe/Middle East/Africa-Ireland-Cork-Cork, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Italy-Lazio-Latina, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Quality Assurance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement