Scientist, Pharmacy II

Technical expert that will independently investigate identify develop and optimize new methods/ techniques to address critical project needs. Continuously seek to improve existing laboratory methods and processes. Read and adapt literature to accomplish assignments. Demonstrate mastery of broad range of experimental techniques and methods of data analysis.

Responsibilities

• Lead projects impacting manufacturing to achieve process efficiencies such as increase in process yield quality improvements cycle time/throughput and cost reduction initiatives.
• Gather and analyze process data using statistical process control methodology for the purpose of monitoring process performance. Develop action plan to increase process robustness prevent product loss and control quality impact.
• Responsible for providing technical support in the resolution of manufacturing investigations and executing assigned tasks as required such as laboratory experiments.
• Lead investigations by following a structure problem solving approach and employing sound scientific principles when identifying root cause and developing recommendations related to product and process. Generate technical justification to support and/or document process deviations/investigations and determine impact in product quality yield and product registration.
• Member of a cross-functional team responsible for implementation of site projects/initiatives (continuous improvement cost reduction capacity increase etc.) that lead to process remediation.
• Project management of smaller team sub-projects in support of larger projects. Responsibility may include project coordination monitoring reporting meeting management and team communication.
• Lead the implementation of process validation for technology transfers operational changes new raw materials and introduction of new process/technology. Generate technical justification determining impact of change and protocols/reports/manufacturing documents that support its execution. Assist the execution of experimental demonstration and validation lots.
• Maintain up-to-date product and process documentation and assure they are in compliance with applicable procedures and regulations. Writes justification memos and scientific reports supporting quality controls and manufacturing documents.
• Provide scientific and technical support during regulatory audits agency inspections and regulatory submissions (IND BLA NDA PAS etc)
• Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of Abbvies EHS program.

Preferred Qualifications:

• Technical knowledge in fundamentals of pharmaceutical process (sterile/aseptic product manufacturing media fill sterilization fill finish operations cGMP).
• Experience with process validation and technology transfers
• Fundamental knowledge of Medical Device Design Control (DHF EU MDR CE Mark)
• Strong data analysis skills and experience (Minitab JMP Lean Six Sigma)
• Demonstrated ability to independently design execute and interpret critical experiments to answer scientific questions.
• Demonstrated ability to learn understand and master new experimental techniques.
• Ability to multitask and work within timelines (Project management).

Qualifications :

Qualifications

• BS or equivalent education with typically 7 or more years of experience or MS or equivalent education with typically 5 or more years of experience.
• Demonstrated ability to independently design execute and interpret critical experiments to answer scientific questions.
• Demonstrated ability to learn understand and master new experimental techniques.
• Ability to multitask and work within timelines.
• Demonstrated scientific writing skills and strong verbal communication skills.
• Demonstrated scientific writing skills and strong verbal communication skills.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand we may ultimately pay more or less than the posted range. This range may be modified in the future. 

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time