Downstream / Purification Associate Scientist, San Diego, CA

Downstream / Purification Associate Scientist, San Diego, CA

Job Duties and Responsibilities

  • Provides 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 purified proteins to support lead generation/optimization and pre-clinical studies.
  • Produces purified proteins under cGMP standards and with cGMP standards and regulations in consideration for production of clinical trial materials.
  • Participate in technical transfer of downstream manufacturing processes from clients and between Development and Manufacturing groups.
  • May lead client projects including the planning, execution, and wrap up.
  • Exercises technical discretion in design, execution and interpretation of manufacturing and production that contributes to project goals.
  • Provides detailed observations, analyzes data, and interprets results.
  • Act 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.
  • Assists in monitoring production or purification schedules, materials, equipment and manpower requirements.
  • Maintains records to comply with regulatory requirements and assists with in-process testing, as needed.
  • Prepares or orders media and buffer components. Operates, and assists in maintaining production equipment as it relates to protein purification.
  • Learns to initiate 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, viral clearance studies, and manufacturing investigations, providing analysis as needed.
  • Drafts technical reports, summaries, protocols, batch records and quantitative analyses.
  • Uses professional concepts in accordance with company objectives to solve simple to moderately-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.
  • May lead and direct the work of junior personnel in the field.
  • 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.
  • Performs other related duties as required.

General Responsibilities

  • Operates to the highest ethical and moral standards.
  • Complies with company's policies and procedures.
  • Adheres to quality standards set by regulations and company policies, procedures and mission.
  • Communicates effectively with supervisors, colleagues and subordinates.
  • Ability to participate effectively as a team player in all aspects of company's business.
  • Demonstrates administrative leadership with knowledge-based expertise in related areas that can be applied to meeting company's strategic goals.
  • Travels as needed.

Job Requirements:

  • Bachelor's degree (BS) in an applicable scientific field, plus a minimum of eight (8) years directly related experience, OR
  • Master's degree (MS) in an applicable scientific field with a minimum of three (3) years industrial experience in process development and cGMP manufacturing.
  • Ability to apply principles, theories and concepts in specialized area of responsibility, together with working knowledge of related disciplines.
  • Knowledge of purification process steps, including depth filtration, tangential flow filtration, chromatography, and viral filtration.
  • 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!  Questions?  Call Carl at 858.207.6311

Why Kelly®?

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®

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.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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