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.
Job Function:
Supply Chain Engineering
Job Sub Function:
Process Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Titusville, New Jersey, United States of America, Wilson, North Carolina, United States of America
Job Description:
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 .
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Switzerland - Requisition Number: R-071146
Belgium and Netherlands - Requisition Number: R-073819
United States - Requisition Number: R-073822
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
We are searching for the best talent for a Fellow, Drug Product - Manufacturing Sterile Products! This hybrid position will be located in Schaffhausen, Switzerland. Alternate hybrid locations may be considered in Beerse, Belgium; Leiden, Netherlands; Titusville, New Jersey (USA); or Wilson, North Carolina (USA).
Are you interested in helping shape the future of sterile biotherapeutics manufacturing and supporting teams that deliver life-saving medicines to patients worldwide? 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. Apply today for this exciting role for the opportunity to make a meaningful impact at Johnson & Johnson!
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.
KEY 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.
QUALIFICATIONS:
EDUCATION:
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
EXPERIENCE AND SKILLS:
Required:
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
Preferred:
Experience leading global, multicultural teams
Lean, Six Sigma, or Process Excellence training or certification
OTHER:
Requires proficiency in English (excellent written and verbal communication skills) to communicate effectively and professionally; proficiency in German, Dutch, or Flemish is helpful
Up to 25% domestic and international travel may be required
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
LI-Hybrid
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Agile Decision Making, Compliance Management, Consulting, Crisis Management, Design Mindset, Disruptive Innovations, Emerging Technologies, Lean Supply Chain Management, Managing Blended Teams, Operational Excellence, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Technical Credibility, Technical Research
The anticipated base pay range for this position is :
$150,000.00 - $258,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
