Johnson & Johnson Innovative Medicine
Global Aseptic & Sterile Manufacturing Fellow - Director
Johnson & Johnson Innovative Medicine, Titusville, New Jersey, us, 08560
Global Aseptic & Sterile Manufacturing Fellow - Director
Johnson & Johnson Innovative Medicine are recruiting for a MSAT Biotherapeutics Drug Product Fellow Aseptic and Sterile Manufacturing to be based in Schaffhausen, Switzerland or Titusville, United States or Beerse, Belgium. As an MSAT Biotherapeutics Drug Product Fellow Aseptic and Sterile Manufacturing, you will hold a strategic role within Global MSAT and will partner with R&D, Make functions, New Product Introduction, the Quality Organization and Value Chain Management teams, as well as internal manufacturing sites, external partners and health authorities to develop and implement robust and holistic aseptic manufacturing strategies for J&J's internal sites and external Network to meet the emerging and future needs of J&J's portfolio. You will share in-depth expertise in aseptic manufacturing, provide guidance on compliance aspects and shape global concepts to deliver on short-to-long term pipeline of initiatives associated to Johnson & Johnson large molecule and parenteral product strategy and grow. Key Responsibilities
Responsible for strategic framework around parenteral Large Molecule Biotherapeutics Drug Products. Collaborate to develop and deploy an enterprise methodology on a Gravel-to-Grave process for robust aseptic manufacturing. Serve as Subject Matter Expert in the global MSAT organization for LM and parenteral products with regard to aseptic manufacturing processes, sterilization technologies and related processes. Shape and continuously improve communities of practice by sharing knowledge around sterile manufacturing practices across JJIM. Promote quality and compliance in sterile manufacturing and validation; mentor others. Develop and launch innovative concepts for sterile manufacturing technologies with a focus on quality by design and future compliance. Collaborate with global teams across the LM network providing knowledge, strategic leadership, and direction across JJIM supply chain. Provide technical support to regulatory filings, inspections, and health authority questions. Support technology transfer projects for new processes in manufacturing operations. Participate in industry conferences and engage with regulators to advance aseptic technologies. Required Knowledge and Experience
Strong expertise (at least 10 years) in pharmaceutical manufacturing processes and products, with focus on low bio-burden and sterile manufacturing. Minimum 5 years of experience in Quality & Compliance / regulatory requirements (GMP) for sterile production. Project management, organizing, planning and coordination skills. In-depth knowledge of Annex 1 guidelines. Personal and Interpersonal Skills
Ability to shape opinions in cross-functional teams; leadership experience in multicultural teams (10+ years). Ability to manage complexity and change; interact at different levels of the organization. Ability to handle conflicting interests and make decisions; customer and team focus for value creation. Ability to work under pressure. Education
Bachelor of Science degree required; Master’s or advanced degree in Life Science, Pharmacy or Engineering desirable. The anticipated base pay range for this position is 146,000 - 211,700 USD.
#J-18808-Ljbffr
Johnson & Johnson Innovative Medicine are recruiting for a MSAT Biotherapeutics Drug Product Fellow Aseptic and Sterile Manufacturing to be based in Schaffhausen, Switzerland or Titusville, United States or Beerse, Belgium. As an MSAT Biotherapeutics Drug Product Fellow Aseptic and Sterile Manufacturing, you will hold a strategic role within Global MSAT and will partner with R&D, Make functions, New Product Introduction, the Quality Organization and Value Chain Management teams, as well as internal manufacturing sites, external partners and health authorities to develop and implement robust and holistic aseptic manufacturing strategies for J&J's internal sites and external Network to meet the emerging and future needs of J&J's portfolio. You will share in-depth expertise in aseptic manufacturing, provide guidance on compliance aspects and shape global concepts to deliver on short-to-long term pipeline of initiatives associated to Johnson & Johnson large molecule and parenteral product strategy and grow. Key Responsibilities
Responsible for strategic framework around parenteral Large Molecule Biotherapeutics Drug Products. Collaborate to develop and deploy an enterprise methodology on a Gravel-to-Grave process for robust aseptic manufacturing. Serve as Subject Matter Expert in the global MSAT organization for LM and parenteral products with regard to aseptic manufacturing processes, sterilization technologies and related processes. Shape and continuously improve communities of practice by sharing knowledge around sterile manufacturing practices across JJIM. Promote quality and compliance in sterile manufacturing and validation; mentor others. Develop and launch innovative concepts for sterile manufacturing technologies with a focus on quality by design and future compliance. Collaborate with global teams across the LM network providing knowledge, strategic leadership, and direction across JJIM supply chain. Provide technical support to regulatory filings, inspections, and health authority questions. Support technology transfer projects for new processes in manufacturing operations. Participate in industry conferences and engage with regulators to advance aseptic technologies. Required Knowledge and Experience
Strong expertise (at least 10 years) in pharmaceutical manufacturing processes and products, with focus on low bio-burden and sterile manufacturing. Minimum 5 years of experience in Quality & Compliance / regulatory requirements (GMP) for sterile production. Project management, organizing, planning and coordination skills. In-depth knowledge of Annex 1 guidelines. Personal and Interpersonal Skills
Ability to shape opinions in cross-functional teams; leadership experience in multicultural teams (10+ years). Ability to manage complexity and change; interact at different levels of the organization. Ability to handle conflicting interests and make decisions; customer and team focus for value creation. Ability to work under pressure. Education
Bachelor of Science degree required; Master’s or advanced degree in Life Science, Pharmacy or Engineering desirable. The anticipated base pay range for this position is 146,000 - 211,700 USD.
#J-18808-Ljbffr