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We are looking for driven, talented Scientists and Product Engineers to join our growing Life Cycle Management (LCM) group. The LCM group works as an integral part of our Consumables Manufacturing process and is tasked with increasing quality and yield within our high volume production environments.
This Scientist 1 position is a hands-on, independent position where the incumbent uses expert knowledge of product characterization and GMP manufacturing processes for new product introduction initiatives of clinical/diagnostic products. This individual will provide technical expertise and leadership in the design and execution of experiments for product/process optimization, analytical method development, and verification activities ensuring the successful transfer of technology transfer into a GMP manufacturing environment. Specific focus areas include:
- Collaborate and guide new product development teams throughout the stages of product development process (PDP) in order to:
- Act as the liaison between development and manufacturing,
- Construct and execute controlled experiments (including DOE's and gauge R&R studies) to improve the production and processing of biological materials, utilizing mathematical techniques and scientific expertise to sort and analyze data and draw valid conclusions;
- Provide technical support for the identification of critical materials and process controls;
- Provide analytical test method development support during pre-formulation, formulation development and manufacture of prototype formulations, clinical trial materials and process scale ups.
- Review analytical method validation, process validation, cleaning validation, stability studies and other product qualification requirements, including reviewing protocols, executed studies and associated reports.
- Participate in phase gate reviews as defined per product development process (Design Control program)
- Define, establish, and manage requirements for successful transfer of technical information into manufacturing, i.e. detailed transfer package deliverable(s).
- Support product characterization activities and method development activities as needed, including recommending materials for reliable performance (material compatibility and availability) and manufacturing scalability.
- Monitor, trend and analyze results from development and pilot lots during the NPI process; track off-targeted production outputs, troubleshoot/perform root cause analysis, and make technical and compliance related recommendations as required.
- Design and execute controlled experiments to optimize processes, address technical failures and quality issues to drive implementation of solutions within the production environment.
- Present clear and concise written and oral communications to colleagues and supervisors, lead and participate in technical meetings, and provide recommendations based on technical results
- Work experience in production, pilot plant, and/or product development following GMP best work practices and techniques is required.
- Work experience with NPI projects, design change control programs as well as having an understanding of product lifecycle management.
- Experience with Design of Experiments techniques, statistical analysis, and statistical process controls.
- Experience with at least several of the following techniques: HPLC, SEC, CE, GC, GC-MS, LC-MS, MALDI-TOF, SDS-PAGE, IEF
- Experience with chemical processes (preferably organic) is required
- Must understand the process of control requirements for production and process improvement as per QSR, FDA, ISO 90001/13485, and other regulatory requirements.
- Highly desirable to have experience and knowledge of operations of IVDs, medical devices, and/or Pharmaceutical products.
- Strong background in analytical characterization of enzymes, oligonucleotides, small molecules, and/or mixtures of the above is highly desired
- Knowledge of material properties, compatibility studies and product performance testing.
- Ability to work independently in a fast paced team environment, meet deadlines, and adapt to rapidly changing priorities across multiple projects in accordance with departmental and company objectives.
- Excellent communication, interpersonal, and leadership skills.
- B.S. & 5+ yrs experience/M.S. & 3+ yrs experience/Ph.D. in: Materials Science or Physical Chemistry, Chemistry, Biochemistry, Chemical Engineering, or Biochemical/Biomedical/Biotechnical Engineering, Bioengineering
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at 858-246-8959. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf