MSAT SM DP LCM Senior Principal Process Scientist Parenterals - 2406192587W

Description

Johnson Johnson Innovative Medicine companies, is currently looking for a Senior Principal scientist – LCM Parenteral Process Scientist, being part of Manufacturing Science and Technology (MSAT)in the Small Molecule Drug Product Platform to be based in Europe with up to 20% travel.

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 https://www.jnj.com/.

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.

Position summary:

MSAT Process Scientist provides scientific expertise to ensure compliance, resilience competitiveness of JJ commercialized Value Optimization and Late Lifecycle portfolio

The role holder is expected to be global SME in the SM DP Parenteral manufacturing operations as an individual contributor to provide technical project support to the commercialized product portfolio, working closely with operations, QA, QC, and various JSC, RD functions. The role holder will leverage strong networking and process expertise to ensure good collaboration between cross functional teams from Value Chains, PES, Make, Planning, Regulatory functions to deliver a wide range of LCM technical projects that includes, but not limited to sophisticated process product issue investigation, product/portfolio supply chain resilience program e.g., source change new site establishment, process robustness optimization, and application of innovation for process intensification and competitiveness. This is applicable to both internal and external manufacturing network, with scope of expertise spanning from lab scale trials to operation shopfloor.

Principal responsibilities:

Representing MSAT SM DP Parenterals as process SME in cross functional teams and provides support for projects at all stages of the product life cycle (optimization, changes in material, investigations) starting after launch to optimize the value.

The focus of the role is:

Define, own and coordinate lab experiments to support:

Compliance and safety issues

The successful implementation of changes such as material change, ensuring compliance/quality/processability, tech transfer

Scientific investigations to look for a solution to support the Supply Chain

Optimize the manufacturing processes

Acting as an SME in drug product parenteral processes; i.e compounding, filtration, filling, freeze drying and visual inspection

Participates in Global Communities of sterility assurance experts and actively shares knowledge with peers within JJ.

Supporting with his/her team with drug product impact assessment the experimental needs for optimizing manufacturing processes making use of innovative technology and reduction of throughput time.

Writing, reviewing and approving lab scale study protocols reports (i.e mixing, filter validation, filter adsorption, nano-milling, filling pump studies)

JSC technical input and technical acceptance into the supply chain including cost and robustness metrics through a process of “touch points”, thereby ensuring “one voice of the customer” towards JCS and consistency across projects and across plants.

Contribution, review, and approval of drug product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc), routine technical support during execution, integration of JSC technical expertise (e.g., platforms, engineering, SME’s) into project execution and support technical implementation at the manufacturing site level

Collaborates with RD, site functions and finance to identify COGS improvement opportunities (COGS optimization process)

Qualifications

Requirements: 10 years of hands-on relevant experience with experimental design and statistical data analysis with BS or equivalent degree. (Aseptic nano-suspension, liposomes, implantable rods manufacturing process experience is plus)

In-depth expertise in Parenteral Liquid formulation and processes for synthetic drug compounds (compounding, sterile filtration, aseptic milling, filling i.e vial, syringe, cartridge filling and inspection)

Knowledge of regulatory guidance related to aseptic processing, validation, cGMP, and combination products

Excellent written and oral communication skills and ability to influence peers, superiors, and partners.

Able to work independently with demonstrated problem solving skill

Proficiency in English (spoken and written) is a requirement

We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure.

Primary Location Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen

Other Locations Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Organization Cilag GmbH International (8525)

Job Function Process Engineering

Req ID: 2406192587W