Scientist / Sr Scientist - Upstream / Process Development, San Diego, CA - Direct Hire
One of our top clients is looking for a talented Scientist with experience in Process Development and Upstream Manufacturing.
Pay is flexible depending on experience.
Job Duties and Responsibilities:
Executes assigned work with full understanding of and ability to apply principles, theories, and concepts in specialized areas of responsibility.
Leads and oversees the work of the Process Development (PD) Leads and Associates in the development of scalable and robust processes on accelerated timelines.
Has technical competency in support of daily operations through research in diverse biological processes.
Uses current scientific literature with the technical capability to select methods and techniques for obtaining solutions within broadly defined practices and procedures.
Produces proteins using mammalian cell culture to support lead generation/optimization and preclinical studies.
Produces proteins using mammalian cell cultures under cGMP standards and with cGMP standards and regulations in consideration for production of clinical trial materials.
Participates in technical transfer of upstream manufacturing processes from clients and between Development and Manufacturing groups.
Leads client projects including the planning, execution, and conclusions.
Exercises technical discretion in design, execution and interpretation of manufacturing and production that contributes to project goals.
Provides detailed observations, analyzes data, interprets results and develops scientifically-sound solutions.
Acts as a Subject Matter Expert (SME) to train others in areas of expertise. Assists and offers guidance to the Process Development group and Manufacturing group as necessary to train on correlated processes.
Oversees production schedules, materials, equipment and manpower requirements.
Maintains records to comply with regulatory requirements and assists with in-process testing.
Operates and ensures appropriate maintenance of production equipment as it relates upstream production activities.
Troubleshoots processing problems, bringing unusual problems (e.g., potential deviations) to the attention of the supervisor.
Initiates deviations, assess product quality impact, and propose Corrective and Preventative Actions (CAPA), as needed.
Sets up and performs scale down models to assist with process validations and manufacturing investigations, providing analysis as needed.
Prepares technical reports, summaries, protocols, batch records and performs quantitative analyses.
Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
Organizes own daily workload schedule and relevant resource requirements.
Operates with minimal supervision on complex systems and equipment.
Mentors and leads the work of junior personnel in the field. Provides training to new personnel in specific technical processes.
Supports project teams on multiple projects simultaneously.
Represents departmental activities as needed, including project teams, task forces, audits and business or technical meetings with outside groups.
Develops effective working relationships with both internal and external partners.
Master's (MS) degree in applicable scientific field, PhD degree preferred.
Minimum either (8) years directly related experience with a MS degree; with a PhD degree, Minimum three (3) years industrial experience in process development and cGMP manufacturing.
Knowledge and skill of mammalian cell cultures and concepts of cell metabolism, protein production, and characterization.
Knowledge and skill in relation to cell culture process steps including cell banking, thaw and expansion, and production (batch-fed and perfusion).
Knowledge of designing of experiments for increase productivity in relation to operation of multivariate experiments using the Sartorius platform ambr250 and stir tank vessels.
Skill and knowledge of scaling up to 500 L or more in single-use technologies.
Knowledge of quantitative and qualitative analytical methods and interpretation of analytical data.
Ability to organize workload, oversee direct reports, and relevant resource requirements.
Skill in leadership duties, to include time management and planning.
Knowledge of products manufacturing following SOPs, batch records and working within a cGMP regulated environment.
Ability to observe technical issues with troubleshooting knowledge of process and equipment problems.
Ability to operate complex systems and equipment and optimize their use in manufacturing in accordance with defined goals.
Knowledge of specific product-related operations in protein purification.
Ability to mentor and train purification associates and leads in process transfer, scale-up, from scientific and engineering perspective.
For immediate consideration, apply today! For questions, email ~~~ or call ~~~.
Why Kelly Â® ?
With Kelly, you'll have access to some of the world's highest regarded scientific organizations-providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career-connect with us today.
About Kelly Â®
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. 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. at ~~~