Kelly Services is currently seeking a Sr. Bioprocess Engineer for a direct hire position in Lenexa, KS.
Job Summary and Purpose:
The Sr Bioprocess Engineer is responsible for providing scientific, technical and equipment support regarding the development of new products and existing product changes. This position will design, plan, lead and execute strategies associated with the process development, troubleshooting, or optimizations that are aimed to deliver reproducible, safe, compliant, and cost effective solutions to the industrial teams.
The Sr Bioprocess Engineer will be responsible for managing, mentoring, and developing a GID Technician.
Responsibilities and Key Duties:
Lead the scale-up/down and transfer efforts of new processes from development to industrial
Lead optimization efforts of current processes by conducting experiments to evaluate relevant process parameters for upstream, downstream, formulation and lyophilization
Participate in the definition and ensure implementation of transfer and process improvement/development rationales (including technical, financial and regulatory aspects) to anticipate industrial needs
Apply DoE and QbD methodologies (when applicable) to develop or improve processes
Lead meetings with R&D, Industrial and Purchasing to implement an industrialization process
Evaluate/analyze process performance (KPIs, CQAs, and CCPs) for process/methods improvement
Define process validation strategy, assist with the generation of process validation protocols and manufacturing instructions, check and approve process validation protocol and manufacturing and testing instructions and write technology transfer plans and reports
Provide expertise to production, early R&D, QA and RA teams as manufacturing process/industrialization expert for process improvement, optimal solution proposition and evaluation
Exchange knowledge with other Global Industrialization teams and contribute to process improvement through sharing and promoting best practices
Ensure that relevant quality and EHS standards/rules and operating protocols and documentations for GID laboratories are followed
Participate in risk assessment meetings with R&D, GMSQ and Purchasing teams to identify and define critical process parameters and critical quality attributes for systems suitability evaluation
Design, schedule, execute and write protocols; must be capable of utilizing statistical software
Update and write GMP procedures and implement corrective and preventive actions
Adheres to documentation guidelines and current SOPs related to experimentation and reporting data
Lead the installation, operation and validation of new equipment ensuring maintenance of equipment and operational status
Conduct training to the different team members on the proper use of equipment or processes
Train, manage, mentor, coach and develop direct report(s)
Participate in the creation of industrial documentation SOPs and batch records to achieve right first-time operation associated with new processes
Shape solutions out of complexity - Is open and curious of others perspectives
Client focus - Has in mind clients satisfaction
Collaborate with empathy - Has a positive attitude towards collaboration
Engage and develop - Clarifies short-term directions
Drive ambition and accountability - Proactively manages own and others work
Influence others - Communicates transparently
Technical / Functional Competencies:
Advanced knowledge of manufacturing operations
Strong communication skills, both written and verbal
Technical writing skills for regulatory documentation
Project management skills
Data management and analysis tools knowledge
Capability to prepare URS for production line
Ability to contribute to building an industrialization strategy from the design of new equipment and its integration into new premises
Ability to scout and evaluate the potential of new technologies
Ability to design and perform capability/robustness studies
Ability to build statistical approach/strategy for problem-solving/improvement processes
Ability to lead a team
Education - MS/PhD in Chemical Engineering, Biochemical Engineering or equivalent
Work Experience - Prefer a minimum of 3-5 years of experience within a cGMP biological production environment, with managerial experience, or an equivalent combination of education and experience
For immediate consideration, please send your resume in a WORD document to firstname.lastname@example.org
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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