Senior Process Scientist Department MSandT METAP

Senior Process Scientist,

member of Manufacturing Science and Technology (MS&T) Team in METAP-CIS Region

Qualifications

Position reports to METAP – CIS Regional MS&T Director and a successful candidate should have :

• Bachelor’s degree in a scientific or technical field, preferably in Life Sciences, Pharmacy or Engineering. Master Degree or PhD is preferred. 10+ years experience in the Pharmaceutical Industry, preferably in R&D and Manufacturing is required.
• Excellent technical know-how on manufacturing process of solid, liquid, semi solid and sterile dosage forms, formulation development experience is preferred.
• Demonstrated capability in project organization and management, including managing third party activities. Capability in process risk assessment, and development and execution of experimental work to address process robustness, productivity, and cost.
• Excellent command on pharmaceutical manufacturing equipment working principles.
• Strong process understanding to deep dive review on investigations.
• Experience in project management, technology transfer, product scaling and commercializing.
• Experience in support of marketed products and formulation / process
• Experience in support of new product introduction from scale up to commercial launch is preferred.
• Process and understanding of business needs and the ability to translate them into actions to meet timelines
• Statistical knowledge for the multi variable data analysis is preferred.
• Have a good knowledge of cGMP (Good Manufacturing Practices) and about product transfer, process validation activities
• Strong analytical thinking, problem solving, negotiation, decision making and result oriented and follow-up skills are essential
• Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Ability to work in leading a team under deadline. Strong verbal and written communication skills are essential.
• Direct or indirect supervisory experience.
• Excellent command of English
• Ability to travel within or out of country
  
  

• Provide technical leadership as a SME to cross-functional teams during technology transfers, commercial products, launches, validation activities, process improvements, alternative supplier qualifications, capacity expansions and perform root cause investigations for manufacturing problems.
• Mainly takes active role at site transfers, to maintain robust manufacturing process in TPM to be able to produce and release the Abbott Products on time without any issue.
• Performs root cause analysis very quickly and effectively to prevent the recurrence of the problem.
• Utilizes in-depth knowledge of technology, literature, and experience to guide decision making processes in complex situations.
• Capable of directing the project management related efforts with the process issues more than one team and more than one project.
• Drives continuous improvement projects, process and formulation improvements, (remediation, development and validation) and responds to technical issues resulting from quality, manufacturing, and / or regulatory to ensure product reliability and cost leadership
• Plays active role during License & Acquisition Due Diligence from Galenical point of view.
• Collaborates with other Regional MS&T Teams to ensure providing technical support to METAP-CIS Region, if needed.
• Provides required galenical and process-based guidance to validation studies examined for existing or new products manufactured by TPMs.
• Leads the validation studies of the Abbott Products, provide feedback and secure the compliance of the validated parameters.
• Review and approve documentation / product samples shared by TPM and assess the risks associated with the manufacturing of the product under the Abbott Logo.