Fellow, Drug Product Manufacturing Sterile Products

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

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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 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 lifesaving 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 & Johnsons 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 Bachelors /University degree or equivalent degree is required; Masters 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 crossfunctional stakeholders at multiple organizational levels

• Capability to handle complexity ambiguity and change while making sound decisions in highpressure 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 internal employees contact AskGS to be directed to your accommodation resource.

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