Sr Manufacturing Associate - Downstream

Sr Manufacturing Associate - Downstream, San Diego, CA

Direct Hire, 4 days a week, 12 hour shifts, Days and Nights Available.

Essential Duties and Responsibilities:

  • Work is performed in a cGMP manufacturing environment.
  • Assumes lead role in various biological purification projects.
  • Responsible for specific product-related operations in protein purification.  Functions as a Subject Matter Expert for manufacturing.
  • Operates and maintains production equipment with single-use materials as it relates to harvest and protein purification (chromatography columns, depth filtration, cassette and hollow fiber-based ultrafiltration equipment, UV monitors, pH/conductivity, viral filtration, AKTA skids).
  • Proposes, plans, organizes and executes manufacturing in production-scale protein manufacturing.
  • Conduct activities in support of production schedules as directed by senior staff.
  • Performs a variety of complex tasks in accordance with cGMP, cGDP, SOPs and Batch Records.
  • Provides detailed observations, analyzes data and interprets results.  Communicates these results to staff and upper management.
  • Initiates deviations, assesses product quality impact and proposes and executes Corrective and Preventative Actions (CAPA).
  • Writes, reviews and approves SOPs, Master Batch Records and other cGMP documentation.
  • Change owner for implementation or revision of equipment, documentation and material specifications.
  • Prepares technical reports, batch summaries, protocols, batch records, specifications and quantitative analyses.
  • Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
  • Reviews completed Production, Buffer and Purification batch records on a daily basis for cGMP compliance and completeness.
  • Supports multiple projects simultaneously.
  • Proposes implementation of production procedures to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success.
  • May cross-train on various tasks including Upstream cGMP manufacturing and R&D processes as needed to support overall success of the Biologics group.
  • Develops effective working relationships with both internal and external partners.
  • Represents departmental activities as needed, including project teams, task forces, audits and business or technical meetings with outside groups.
  • Provides feedback to Senior Management.

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.
  • Travels as needed between GMP facilities, to attend professional conferences, and train on new technologies.

Job Requirements:

  • Bachelor's degree (BA/BS) in Biology, Chemistry or a scientific related field.
  • Minimum of five (5) years of experience in a cGMP manufacturing/laboratory environment, with two (2) of those being in a lead role.
  • Knowledge of purification process steps including harvest, column packing, chromatography, UF/DF and nanofiltration as well as investigating new technologies.
  • Skill with manufacturing of products following SOPs, batch records and working within a cGMP regulated environment.
  • Ability to observe technical issues and troubleshooting of process and equipment issues.
  • Ability to operate complex systems and equipment and optimizes their use in manufacturing in accordance with defined goals.
  • Knowledge of specific product-related operations in purification.
  • Skill in leading Purification Department in execution of production and related activities.
  • Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meet Abzena¿s strategic goals.
  • Ability to ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to ensure uninterrupted supply of products produced.
  • Ability to work on complex assignments of diverse scope and ability to exercise judgment within defined procedures and practices to determine appropriate actions.
     

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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