Job title:
Investigations lead
Company
Johnson & Johnson
Job description
Johnson & Johnson is currently seeking an Investigation Lead to join our MSAT department CAR-T EMEA, located in Ghent Belgium .At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com/.The Manufacturing Science & Technology CAR-T EMEA organization is an organization which provides and supports a high degree of assurance that specific processes will consistently produce and meets its pre-determined specifications by deploying process validation, process system engineering, data architecture and continuous process verification and process investigation.The Process Investigation Lead is the role for providing quality investigation oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GxP environmentThe Investigation Lead will be part of this MSAT team and has the mission to:
- Own the investigation process and methodologies, create awareness and educate the organization on the importance of and how to adequately and efficiently handle quality investigations.
- Lead and support a team of investigators who are responsible for handling multiple department manufacturing investigations as appropriate and/or establish strategy to quickly driving to root cause to meet critical release windows (the highest priority being safe and timely product release for the patient).
- Oversee processes and standards and support the implementation of CAPAs related to the manufacturing process together with MS&T process expert, process engineer and knowledge management.
- Maintaining and further optimizing the investigation tracking and supporting QEM systems, while following up on investigation metrics to allow timely and adequate prioritization setting, escalation and keeping the investigation process under a state of control.
- Ensure a system is in place for upfront preparation of and act as the company support for Regulatory Authorities inspection of investigational Manufacturing Science and Technology subjects, accountable to defend the strategy, investigation reporting and potential answer to observation.
- Build solid and long-lasting connections with different stakeholders in order to ensure smooth alignment and handling of complex investigations, while acting as the shopfloor single point of contact.
Key Responsibilities:
Process Robustness:
- Own the process investigation knowledge of the cell and gene therapy manufacturing process technology and maintain oversight on process capability to ensure processes are robust and continuously improving.
- Provide support and technical expertise to the Technical Operations team in support of ongoing technical transfer (incl. process validation – continuous process verification) and manufacturing operations.
- Support Manufacturing team to troubleshoot and resolve complex scientific/technical problems.
Quality and Compliance:
- Apply and implement appropriate risk assessment methodologies and root cause analysis tools and assess product quality impact.
- Ensure a system is in place for upfront preparation of and act as the company support for Regulatory Authorities inspection of investigational Manufacturing Science and Technology subject, accountable to defend the strategy, investigation reporting and potential answer to observation.
- Stay up to date with regulatory requirements and state of the art guidelines, maintain permanent inspection readiness, actively support regulatory inspections and preparation thereof as SME, and support the implementation of actions resulting from such inspections.
- Draft, feed, review/revise, and/or support writing of (not limited to): Investigations (incl. impact and risk assessments, corrections, CAPAs), Change controls, Reports, Qualification and validation protocols and reports, Technical assessments and rationales, SOPs and work instructions, Batch records
- Continuously maintain compliance with internal training requirements.
Continuous Improvement:
- Support the implementation of quality investigation resulting CAPAs related to the manufacturing process.
- To further maintain and lead the investigation dashboard and supporting QEM systems and identify opportunities for improvement.
- Ensure connection between recurrent deviations and process robustness activities, perform trending and feed the organization based on lessons learned from investigations.
- Contribute to technical feasibility studies related to process improvement and implementation of new manufacturing and automation technologies.
- Provide technical expertise to support the implementation of process improvements, new manufacturing technologies and automation, that would provide reduction in COGs, increase throughput, capacity and quality compliance.
Role Specific:
- People management skills:
o Regular 1:1s with direct reports (incl. performance and personal development review)o Knows how to provide feedbacko Create/maintain an open trust environment with direct reports and other team memberso Have the ability to guard the team’s capacity and workloado Identify business priorities and reprioritize accordingly to guarantee business continuityo Perform/participate in hiring interviewso Coach, mentor, train and further develop investigators.o Setting long-term objectives.
- Build strong partnerships in a matrixed environment, i.a. by liaising with different internal cross-functional teams such as Manufacturing (Operations), QC (IPL) Supply Chain, Engineering and Quality, as well as effectively integrating with external collaborators, to drive projects/programs forward and ensure efficient execution of process validation and production schedules (clinical and commercial).
- Ensure seamless flow of knowledge and information across functions, departments, and with other sites when applicable, resulting in fast and effective resolution of issues.
- Act as delegate for Investigation Manager or other Investigation Lead responsibilities upon request.
- Participation of key/industry leading conferences, job days and other opportunities to promote the organization and CAR-T technology.
- Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with manager for decisions outside established processes.
Qualifications- Required knowledge and skills:
- A minimum of Master’s degree in Molecular Biology, Cell Biology, Biochemistry or related area in the Life Sciences is required. A PhD in the afore mentioned areas is preferable.
- Minimum 5 years of operations experience within a cGMP environment (manufacturing/quality/development) in the biotech/biopharma industry and preferably cell/gene therapy.
Capabilities, knowledge and skills:
- Leading by example with a motivating management style.
- Experience with directly supervising employees is preferred.
- Knowledge of cGMP regulations and FDA/EU guidance related to ATMPs.
- Ability to work independently and successfully under minimal supervision and integrate cross-functional issues and balance competing priorities effectively.
- Born team player.
- Excellent scientific writing skills.
- Being able to manage shifting priorities and multiple tasks simultaneously to meet critical deadlines in a fast paced and dynamic, growing environment.
- Positive and pro-active attitude.
- Results driven while working within GxP framework of procedures and rules.
- Excellent organizational skills.
- Strong analytical mind, problem solving and critical thinking skills. Being able to trouble shoot and resolve complex scientific/technical problems.
- Advanced computer skills and practical knowledge.
- Clear communicator with ability to build strong partnerships.
- Accurate, Authentic, Transparent, Passionate, Fearless and Accountable.
- The individual will communicate effectively with people at all levels, including the ability to understand their priorities, and to earn their respect and trust, along with the willingness to provide them with the best
- Fluent Dutch and English.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.
Expected salary
Location
Gent, Oost-Vlaanderen
Job date
Thu, 19 Dec 2024 23:57:21 GMT
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