Fellow, Drug Product - Manufacturing Sterile Products

Johnson & Johnson • Titusville, NJ

2d • Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine . This role will partner across R&D, Quality, Manufacturing, and external networks to influence global aseptic manufacturing strategies, advance innovative technologies, and guide execution across a complex supply chain. The Fellow is a strategic role within Global MSAT and is responsible for partnering with R&D and Make functions, New Product Introduction, the Quality organization, and Value Chain Management teams, as well as internal manufacturing sites, external partners and health authorities. They will develop and implement robust and holistic aseptic manufacturing strategies for our internal sites and external network to meet the emerging and future needs of Johnson & Johnson's portfolio. The Fellow will also share in-depth expertise in manufacturing of sterile products, provide guidance on compliance aspects, and shape global concepts to deliver on short- to long-term pipeline of initiatives associated to Johnson & Johnson Biotherapeutics and parenteral product strategy and growth.

Requirements

• Minimum of a Bachelor's /University degree or equivalent degree is required; Master's or advanced degree (PhD) in a scientific field (Life Science, Pharmacy or Engineering) is preferred
• Minimum of 10 years of relevant work experience
• Strong expertise in one or more of the following areas: pharmaceutical manufacturing processes, products, and equipment, sterile manufacturing, visual inspection, and/or container closure integrity
• Proven understanding of Quality & Compliance / regulatory requirements (GMP)
• Experience with project management, organizing, planning and coordination skills
• In-depth knowledge on guidelines like FDA, ANNEX1, and/or Good Manufacturing Practices (GxP), including adherence to applicable cGxPs, incident and deviation reporting, and proactive compliance improvement
• Demonstrated ability to influence and align cross‑functional stakeholders at multiple organizational levels
• Capability to handle complexity, ambiguity, and change while making sound decisions in high‑pressure situations
• Strong customer and team orientation with a consistent focus on value creation
• Track record of driving innovation and continuous improvement to support competitiveness
• High level of agility, flexibility, and resilience; effective in environments with stretched goals
• Strong communication, motivation, and negotiation skills, with the ability to assert ideas and create impact
• Requires proficiency in English (excellent written and verbal communication skills) to communicate effectively and professionally
• Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week

Nice To Haves

• Proficiency in German, Dutch, or Flemish is helpful
• Experience leading global, multicultural teams
• Lean, Six Sigma, or Process Excellence training or certification

Responsibilities

• Manage the strategic framework around parenteral Biotherapeutics Drug Products, in conjunction with other key experts and partners to develop and deploy a JJIM enterprise methodology on a gravel-to-grave process on robust manufacturing of sterile products.
• Serve as a Subject Matter Expert (SME) in the global MSAT organization to cover needs for Biotherapeutics and parenteral products with regard to aseptic manufacturing processes, visual inspection, container closure integrity, and related processes.
• Shape and continuously improve communities of practices by sharing outstanding knowledge around critical sterile manufacturing practices and concepts across different platforms within JJIM.
• Proactively promote quality and compliance in the areas of sterile manufacturing and validation and mentor others to do the same.
• Develop and launch innovative concepts for sterile manufacturing technologies by focusing on quality by design and future prospective compliance.
• Collaborate with skilled and diverse teams across the global Biotherapeutics network providing knowledge, strategic leadership and direction across JJIM supply chain.
• Provide technical support to regulatory filings, regulatory inspections, and health authority questions.
• Collaborate in technology transfer projects supporting implementation of new processes in manufacturing operations.
• Participate in industry conferences, shape opinions , and collaborate with heath authorities or regulators.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior