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The MS&T Process Scientist, IHI provides overall technical support to the Self Care manufacturing operations group at IHI, including formula and process support, technical projects, investigations and validation execution.
The role partners with the global MS&T CoE’s, the regional MS&T team and with internal & external Manufacturing management and Quality Assurance partners in the region to execute technical projects including technology transfers, process capability improvements, and compliance remediations impacting cost, compliance, validation activities and customer service.
Function holder also assumes responsibility for executing solids and liquids projects with the IHI site.
The position has direct responsibility for collaboration of technical and functional resources to drive continuous improvement and consistency in tech transfer and manufacture of solid and liquid dose OTC products/processes.
- Ensure quality and compliance in all actions:
- Attend GMP training on the schedule designated for role and as appropriate for role.
- Adhere to strict compliance with procedures applicable to role.
- Exercise the highest level of integrity in the tasks performed.
- In a timely and prompt manner, identify, report and seek correction for deviations noted in the workplace.
- Embrace a behavior of employee involvement and commitment to doing the job right the first time.
- Ensuring employees under the position’s scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year.
- Promoting an environment of employee engagement in the workplace.
- Seeking prompt identification, reporting and correction of deviations in the workplace as noted by employees.
- Execute technical projects in accordance with the site, MS&T and JnJ policies and procedures
- Provide support to the Process Science Lead in the progress of key projects impacting revenue growth, quality improvements, compliance remediation, and cost reduction. Effectively collaborate with cross-functional leaders to optimize business results. Provide support & guidance to resolve issues impacting timely completion and achievement of project goals.
- Partners with the Validation Lead to execute site Process, Packaging, and Cleaning Validation activities at IHI
- Partners to deliver and execute key projects according to critical processes including, but not limited to, Tech Transfer, Characterization, and Validation.
- Support effective product lifecycle and knowledge management in close collaboration with the Regional and Global Technical Leaders and technical need state leaders.
- Partner with Research and Development to establish and maintain processes for planning, developing, and commercializing new products resulting in well-characterized, validated, highly capable, cost effective manufacturing processes.
- Bachelor’s degree (or equivalent) in Chemistry, Pharmacy, or Engineering is required. M.S., or Ph.D in Chemistry, Pharmacy, or Engineering is preferred
- 3-4+ years of industry experience is required. Relevant experience includes product/process development of pharmaceutical/OTC /Medical Device products, manufacturing of pharmaceutical/OTC/Medical Device products; R&D, Technical Services, Quality & Compliance, Validation experience or Engineering in pharmaceutical/OTC field
- knowledge and application of FDA, ICH and other applicable regulatory requirements and latest guidance in the development, validation, and manufacture of pharmaceutical and OTC products would be required
- Ability to collaborate with and influence manufacturing site leadership teams regarding prioritization and resourcing required.
- Ability to inform, communicate with, and influence Senior Management regarding validated state of respective products/processes and indicated priorities required.
- Knowledge and application of pharmaceutical/OTC product and process development; life-cycle management of this class of products including strategies for continuous improvement would be desirable
- Knowledge and application of pharmaceutical/OTC manufacturing and formulation technologies for liquid and solid dose manufacturing and product development is desirable
- Experience in performing process, cleaning or other validation activities in a regulated environment desirables
- Ability to provide technical leadership in problem-solving and decision-making; to collaborate with and influence business partner leaders with a focus on data, science, and technology required.
- Ability to constructively challenge cross-functional project teams and business partners to achieve project goals and global make strategic plans required.
- Strong collaboration, communication, and presentation skills required.
Indonesia-Jawa-Jakarta Raya-Jl. Raya Bogor KM.28 Kel. Pekayon, Kec. Pasar Rebo
PT Integrated Healthcare Indonesia