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Hospira, a the company company, is the global leader of sterile injectable drugs and infusion technologies, committed to putting patients first by improving access and care worldwide.
Supporting the company Essential Health (PEH) business unit (formerly the company Global Established Pharmaceutical (GEP) organization) the experienced Pharmaceutical Sciences R&D Formulation Senior Scientist will primarily be responsible for laboratory and manufacturing activities for assigned sterile injectable projects (e.g. formulation and process development, tech transfer, validation support), including but not limited to developing timelines and work plans. In collaboration with the analytical group, s/he will generate, development and submissable data for assigned projects; using a Quality by Design (QbD) approach, investigate formulation and process performance, reliability and improvement issues. S/he will work directly with external contract drug manufacturing organizations (CMO's) as needed, which may require both domestic and international travel. The Formulation Senior Scientist will also assist with preparing and reviewing technical documents, including formulation justification document, QbD/validation protocols & reports and technical reports.
S/he will perform all lab and processing technique assignments, and is able to troubleshoot most processing equipment; routinely design complicated experiments that lead to a fundamental understanding of how critical formulation and process variables affect a complex drug product's critical quality attributes; make routine use of scientific literature, and has a good understanding of the disciplines beyond pharmaceutics and analytical chemistry that also play into drug development including intellectual property (IP) protection, regulatory strategy, microbiology, etc. Effectively functions as a PEH PharmSci representative on project
teams. When assigned direct reports, will be responsible for colleague professional growth and
for contributing to performance reviews.
This is an outstanding opportunity for an experienced R&D professional to grow professionally/scientifically through involvement in a large variety of project portfolios of complex and differentiated pharmaceutical sterile injectable drugs.
This position is located at a flagship R&D site in north suburban Chicago/Lake Forest; relocation provided.
•Leads and plans formulation/process development assignments and activities to meet established project goals and timelines
•Directly or through others, leads and supports formulation and process development for complex drug product projects from formulation design through exhibit batch manufacture and support for validation studies/commercial launch. Includes pre-formulation and formulation/process development of complex sterile injectable pharmaceutical dosage forms (includes solutions, lyophilized products, suspensions, nanosuspensions, co-solvent systems and emulsions)
•Development of manufacturing processes at lab scale that are suitable for transfer to commercial manufacturing
•Technical transfer to manufacturing site, including providing on-site assistance during batch manufacture to facilitate knowledge transfer and solve problems
•Supports technical due diligence for potential CMO's and in-licensing opportunities; determines feasibility of overcoming the technical challenges identified
•Prepares and reviews technical documents, including reports and protocols; provides the necessary documentation for regulatory submissions as required and writes deficiency responses
•Based on expert knowledge, is frequently brought into multi-faceted problem solving or strategy teams to resolve wide-ranging problem issues affecting drug development
•Stays abreast of the scientific literature looking for new technological approaches
•Work directly with parties beyond PEH PharmSci/R&D, including but not limited to 3rd party analytical labs, CMOs, and involvement with other divisions of the company
•Generates, analyzes and presents scientific data at team meetings; explains cause and effect relationships and may propose additional experiments to prove/disprove hypotheses
•Provides training, technical expertise and support to the analytical staff; acts as a coach to junior staff
•Identifies opportunities for quality enhancement and operational efficiencies and develops efficient methodologies to track the progress
•Performs duties with a high level of independence
•Expected travel 15 - 20%
•The position is located in north suburban Chicago/Lake Forest, IL; relocation provided
•Bachelor's degree in pharmaceutics, chemical engineering or similar technical discipline is required; PhD or MS degree is preferred
•Required: 3 years experience in formulation and process development, tech transfer, validation support in the pharmaceutical industry; chemical, food or other regulated industry experience will be considered; strong consideration will be given to individuals with previous experience working for a pharmaceutical contract manufacturing organization (CMO)
•cGMP laboratory is highly preferred
• Formulation and process development experience with complex sterile injectable, generic drug products including peptides, liposomes, emulsions, suspensions, solutions, and/or lyophilized drug products is desirable
•Written and oral communication skills and the use of MS Office (Word, Excel) are required
This position involves frequent work within an analytical testing lab, in the presence of chemicals, with appropriate Personal Protective Equipment (PPE). Occasional work within a cytotoxic analytical lab in the presence of potent and cytotoxic compounds is required (with appropriate PPE).
Other Information - Internal
•Colleagues who are issued any type of progressive disciplinary action on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date disciplinary action is issued.
•System limitations prevent mutual participation in cross-company (the company - legacy Hospira) Employee Referral Programs at this time; thank you for your patience
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