Sr Formulation Scientist

Job title:

Sr Formulation Scientist

Company:

Johnson & Johnson

Job description

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 atFor 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.Job Description:J&J Innovative Medicines is recruiting a Sr Formulation Scientist.MSAT Small Molecule Drug Product is accountable for capturing and intensifying the scientific cornerstones and leading productivity, compliance, and sustainability throughout the commercial lifecycle.As a key member, you will be responsible for scientific assessment and optimization of formulation & process robustness, enhance product quality, and ensure regulatory compliance in the domain of(semi-)solid dosage forms. The ideal candidate will have a strong background in pharmaceutical sciences or physics with a passion for innovation and problem-solving.Responsibilities

• Provide technical support to multidisciplinary product teams for late-stage drug product development, technical transfer, PPQ and commercial manufacturing operations by means of

o Sensitivity analysis: Guide experimentation to establish DS-properties meeting requirements for optimal DP-manufacturability.o BP²AL assessments.o Root cause analysis for quality, stability, and yield deviations.o Impact assessment of process variations, equipment modifications and raw material changes

• Apply scientific/engineering principles and techniques to characterize, optimize and implement processes and solve technical challenges at the interface of DS-properties, formulation, process, equipment and environmental controls.
• Responsible for planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development in support of commercialization and lifecycle management of drug products (to support impact assessment of planned changes in material, process parameter, process instructions, equipment, or process technology).
• Writing/reviewing/approving of protocols, reports, and regulatory submissions.
• Monitor market trends, competitive landscapes, and emerging regulations in the arena of formulations, formulation components, pharmaceutical technology and manufacturing processes, and quality to influence and inform strategic decision-making throughout the product life cycle.
• Act as SME to prepare and support technical project reviews and operational excellence initiatives.
• Responsible for managing the cleaning process development for DP-operations.
• Support or lead initiatives for compliance, resilience, formulation & process robustness optimization and competitiveness.
• Collaborate with TDS and MSAT expert communities to establish, maintain and deploy best practices for formulation and process development and intensification, to advance the scientific foundations in SC.
• Use and influence the scientific community to impact J&J IM’s ability to build long-term value.
• Leverage networking and influencing skills to ensure good collaboration with partners in MSAT, TDS, PES, Quality, Regulatory, MAM and DOTS.

QualificationsRequirements

• Advanced degree in Pharmaceutics, Biotechnology, Engineering, Physics, or related area
• 5 – 10 years of experience in development and optimization of solid dosage forms
• Experimental proficiency in pharmaceutical development of conventional (IR, MR), enabling formulations, and/or drug delivery systems.
• Physicochemical understanding of material functionality, formulation design and robustness, manufacturability, stability, and bio-pharmaceutical performance aspects.
• Strong knowledge of IPC, analytical release tests, characterization methods, compatibility, and accelerated stability protocols
• Proficiency in utilizing statistical packages for experimental design and analysis.
• Excellent analytical and problem-solving skills, with the ability to interpret data, identify trends, and draw actionable insights.
• Effective interpersonal and communication skills, with the ability to articulate technical concepts to diverse audiences and collaborate effectively with cross-functional teams.
• Demonstrated track record of project management, including the ability to prioritize tasks, meet deadlines, and deliver high-quality results.
• Ability to think critically and creatively and pay attention to detail.
• Strong networking skills to establish and participate in academic and industry network.
• Experience with problem-solving and risk analysis methodologies.
• Good presentation and technical writing skills.
• Knowledge of regulatory requirements and guidelines related to pharmaceutical manufacturing (e.g., FDA, EMA) is preferred.
• Language: English

Expected salary

Location

Beerse, Anvers

Job date

Thu, 26 Sep 2024 07:32:06 GMT

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