Research Associate - II in Oceanside, CA at GDH

Date Posted: 6/2/2018

Job Snapshot

  • Employee Type:
  • Location:
    Oceanside, CA
  • Job Type:
  • Experience:
    At least 3 year(s)
  • Date Posted:
  • Job ID:

Job Description

Title: Sr Research Associate II - Protein Purification Process Development

Specific Responsibilities and skills for Position:

• A thorough understanding of purification process development for early and late stage protein therapeutics is required. The successful candidate will be expected to demonstrate hands-on technical leadership in the laboratory, oversee and delegate experimental/project responsibilities as needed, champion technology development projects, be involved in new product evaluation, scale-up, process optimization, definition of process platforms, with Technical Operations technology transfer to clinical/commercial manufacturing and authoring/reviewing regulatory documents.
• Broad understanding of downstream development and scale up including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal.
• Participate in technology transfer from process development to clinical and commercial GMP manufacturing, including CMO selection, definition of bill of materials, batch record review, and discrepancy resolution. Serves as process development representative during purification operations, provides technical trouble-shooting and identifies opportunities for future process and equipment improvements.
• The applicant should be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments. Ability to proactively identify issues and develop solutions in a collaborative multidisciplinary environment. This is a highly collaborative environment where willingness and ability to communicate and work effectively with individuals across various project teams is essential.
• Candidates should be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking. The applicant is also expected to exercise considerable latitude in determining objectives and approaches to assignments.
• Strong skills to mentor, motivate, and develop more junior people in the group is highly desirable.
• Makes decisions affecting direction of project and for ensuring project timelines are met.
• Makes key insights and decisions to direct project with minimal data if necessary and understands impact of results. Writes technical reports. Delivers presentations in technical review.

Essential Functions:

• Plans and executes assigned experiments, with increasing independence, that support Process Development activities and project goals.
• Executes reactions and makes key observations during reaction, work-up and isolation.
• Familiar with Pilot Plant operations and able to write master batch records and safety summaries with limited supervision.
• Demonstrates and applies an advanced level of understanding project goals and methods.
• Collaborates with supervisory personnel to develop strategy and tactics.
• Recommends alternatives, researches new methods and techniques and proactively seek out senior personnel to discuss potential solutions to problems.
• Participates in group meetings. Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
• Always works with safety in mind.
• Uses good verbal communication skills and interpersonal skills to provide insight into the processes used to achieve experimental results.
• Demonstrate skills in data analysis and ability to evaluate quality of data.
• Works with collaborative communication and problem solving spirit.

Knowledge, Experience and Skills:

• 5+ years of experience with BS degree in a relevant scientific discipline.
• 3+ years of experience with MS degree in a relevant scientific discipline.
Onsite Offsite: Onsite Offsite Onsite