Position Summary:
Key leader within a group responsible for performing process development, improvements and sustaining effort in a high volume, multi-product manufacturing environment. This includes timely completion of small-scale experiments, scale-up, technology transfer, cGMP support for programs that bring new products to commercial manufacturing phases, troubleshooting problems, analyzing data and issuing reports.
Collaborate and communicate within the framework of cross-functional and multi-disciplinary process development. The individual will interact extensively with other departments such as research and development, manufacturing, facilities, supply chain, project management and quality to develop processes for new products and sustain and improve processes for existing products.
Position Responsibilities:
- Key leader in process definition, improvement, design, development, sustaining and quality test activities in conjunction with Manufacturing, Validation, Supply Chain, Quality Assurance, Facility and Regulatory Affairs.
- Design, execute and lead experiments for optimization and process robustness studies. Leads experimentation and manufacturing support to address complex yield and quality issues and drives implementation of solutions in manufacturing environment to meet quality and production goals.
- Leads technology transfer of multiple programs spanning all phases of product lifecycle, including design, development, pilot run, scale up and oversight of cGMP, engineering and commercial manufacturing.
- Serves as a peer-recognized subject matter expertise.
- Organizational support and cross-functional project team leadership and participation. Advises management on goals and project direction.
- Effectively leads, trains and mentor group.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Position Requirements:
Skillsets
- Strong program and project management skills.
- Work experience in the biotech industries is strongly preferred.
- Proficiency in optics and imaging, chemical processes and analyses.
- Possess cGMP knowledge. Experience in FDA-regulated environment is a plus.
- Experience in a high-tech, high-volume consumables manufacturing industry.
- Excellent organizational skills and attention to detail required.
- Competency in programming language to perform data query, building data analysis tool and simulation model is a good-to-have
Competencies
- Ability to work in a fast-paced environment with demonstrated capacity to juggle multiple competing tasks and prioritize accordingly to meet program and product quality/availability timelines.
- Excellent problem-solving abilities.
- Thorough knowledge of advanced scientific theories, principles, concepts, experimental techniques, industry practices and standards.
- Proven record of technical leadership, ability to motivate and influence technical rigor.
- Dealing with and managing change.
- Extensive project leadership experience to drive the planning and management of risks, priorities and contingencies.
- Good inter-departmental communication skills.
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Experience/Education/Skills:
Typically requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years’ experience; or equivalent experience.
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. 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. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact [email protected]. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.