Senior Scientist I Parenteral and Eyecare Product Development ST On-site CA

The PDS&T Parenterals/Eye Care group is seeking a motivated Senior Scientist to design innovative formulations and develop robust manufacturing processes for clinical phase and commercial products of ophthalmic drug products. This person will apply scientific principles as well as QbD and DoE approaches to systematically design and conduct scientific experiments and provide critical analysis and interpretation of the data conducts studies in the area of formulation and process development in support of product innovation and lifecycle management of marketed products. This position will be an integral part of the product development and CMC teams and is highly collaborative across functions such as analytical microbiology device engineering internal and external manufacturing quality assurance CMC regulatory affairs supply chain and Operations Manufacturing Sites.

Responsibilities:

• Plans directs and executes formulation and process development activities in support of development of new products intended for clinical trials and commercialization. Conducts research in the area of formulation sciences and manufacture technologies in support of innovative product and process development and lifecycle management of marketed products.
• In concert with QA and Manufacturing Support groups coordinates the activities required to scaleup and transfer new process from pilotscale to clinical and commercialscale at the designated site of manufacture.
• Provides scientific and technical leadership on one or more areas of formulation sciences and manufacture technologies. Develops and maintains a current basic knowledge of global CMC regulatory submission requirements GLP/GMP requirements & device regulations (ISO). Reviews internal and external technical documents writes technical memos/reports patents scientific articles.
• Represents department at project/CMC/Technology Transfer teams and works closely with other analytical microbiology device engineering internal and external manufacturing quality assurance CMC regulatory affairs supply chain and Operations Manufacturing Sites to meet project timelines and objectives.
• Generates and maintains all required documentation including logbooks lab notebooks development/technology reports and manufacturing records to ensure products and processes are developed according to internal and regulatory guidelines.
• Maintains current knowledge level of formulation sciences and manufacture technologies by regularly reviewing technical literature regulatory documentation and attending technical training courses to ensure that work performed is in accordance with the latest technical and regulatory information. 

Qualifications :

• Bachelors Masters or PhD in chemical engineering pharmaceutical sciences chemistry pharmaceutics or related disciplines with 8 (Bachelors) 5 (Masters) or 12 (PhD) years of relevant industry experience.
• Strong laboratory skills and experience focused on formulation screening manufacturing process development for sterile liquid formulations.
• Scientific problem solving experimental design and trouble shooting skills.
• Solid understanding of the various unit operations of aseptic manufacturing such as compounding/mixing filtration filling for liquid products.
• Experience in laboratory documentation systems including ELN and demonstrated experience with technical report writing. Technical understanding and experience with small molecule products manufacturing development quality and analytics is required.
• Knowledge and experience with FDA and global regulatory requirements for CMC issues is required.
• Demonstrated excellence in writing presentation and overall communication.
• Must be able to operate as a functional area leader and utilize knowledge of pharmaceutical science chemical engineering literature and experience to guide decisions in complex situations.
• Knowledge of fundamental applications of statistics is preferred.

Computational modeling experience is a plus.

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 of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and 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 shortterm 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 any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and 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. 

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