We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing.
The Process Development Associate II supports both current and new product development projects and is responsible to assist in designing and developing manufacturing processes to optimize capacity, materials, and process flow with the aim of reducing variability within the processes, reducing cost, and improving operating capabilities. Main objective is to identify, develop, and verify processes from early developmental to implementation into manufacturing.
Process Development Associate will work cross functionally with engineers, scientists, production employees, management, Research & Development, Quality Assurance, Quality Control, and Regulatory Affairs to ensure processes and designs meet the end users needs. This position is located in the La Jolla, CA office and reports to the Manager, Process Development.
- Contributes to project objectives within area of expertise by providing experimental data and contributing to problem solving.
- Assists in the development of new processes or products, executing Process Development studies, and running lab assays.
- Proficient at aseptic processing and able to maintain cell culture and constructs sterile consistently.
- Able to train others on areas of expertise.
- Area of work will be focused on 2 or more defined projects. The projects may be of broader scope and have aspects that are not clearly defined.
- An awareness of how project fits in with corporate initiatives and goals.
- Ability to work independently on defined project as well as part of a team.
- Prepares technical reports, summaries, protocols and quantitative analyses of basic experiments.
- May participate in external seminars and scientific conferences.
- Has full understanding of and the ability to apply established principles, theories and concepts in area of responsibility.
- Projects may require familiarity with current scientific literature together with the capability to select methods and techniques for obtaining solutions within generally defined practices and policies as well as familiarity with bio processing methodologies.
- Projects may require familiarity with cGMP and/or GLP processing.
- Contacts are primarily with direct supervisors and others in section or group for guidance and regarding status of work projects.
- May interact with other sections/divisions on routine matters.
- Bachelor’s Degree in a scientific discipline required.
- 2-5 years of related industry experience required.
- Proven technical proficiency and demonstrated skill in planning and interpreting experiments
- Uses own judgment to design and execute independent follow-up experiments
- Demonstrated understanding of analysis and interpretation of relatively complex experimental data with proficiency in problem solving and protocol refinement.
- Effective communicator (written and verbal), especially within their area(s) of expertise. Ability to participate and discuss data or various topics at team meetings. May be required to present findings to team.
- Experience working in a GMP environment/medical device industry.
- Good computing skills including Microsoft office.
- Familiarity working with cell based aseptic processes is desirable.