Product Specialist II-Bioproduction

About Us

At FUJIFILM Biosciences, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners.

Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments: healthcare, electronics, business innovation, and imaging.

Responsibilities

• Collaborate with internal teams to progress qualification of new raw materials and packaging components for new products.
• Resolve discrepancies in information and/or expectations in terms of new custom raw material evaluation; negotiate as required to prioritize actions that meet customer requirements for custom product provision.
• Collate user requirements, technical information, and market information on new raw material requirements.
• Ensure that assigned new opportunities are evaluated in a timely fashion and provide feedback to customers within a target turnaround.
• Manage communication between internal teams, product managers, and CXT project managers on new raw material qualification requirements and provide timely updates to relevant stakeholders.
• Host routine forums/meetings to ensure alignment and progress of new product evaluation and raw material qualification among key functional departments.
• Collaborate with cross-functional teams to assess new raw material testing requirements and consolidate pricing/cost information for quotes or approvals.
• Manage customer site qualification requests—oversee and coordinate customer requirements with Sales/Global Strategic Account managers.
• Maintain site qualification status updates on Power BI and provide monthly reports to relevant stakeholders and upper management.
• Host and participate in weekly/bi-weekly meetings with relevant stakeholders (e.g., Sales, QA team, CXT, or LSM teams) to obtain updates and align on new customer requirements.
• Collaborate with CXT Project managers on qualification sample requests, ensuring timely delivery of samples to customers.
• Initiate and manage change requests (CRs) for adding additional sites to existing products to be made at a new manufacturing site.
• Manage the stability study process for new products: provide stability study quotes to Sales, oversee new part number setup, work with QC and Territory Managers to provide timely updates, protocols, interim reports, and final reports, and ensure invoices are prepared on time.
• Build relationships and guide teams that include representatives from multiple functional areas.
• Enforce a safe culture/environment that promotes active, open, and honest communication by all stakeholders.
• Develop detailed reports and comprehensive documentation to track and report progress.
• Monitor and document issues or bottlenecks and implement ways to resolve them.
• Measure and track key performance indicators using appropriate systems, tools, and techniques.
• Review and optimize business processes to ensure efficiency and accuracy of information.
• Serve as a subject matter expert (SME) for raw material and site qualification processes; provide training to the sales team or other new team members.

Requirements

• Bachelor’s, Master’s, or advanced degree in Life Sciences (Biology, Chemistry), Bioengineering, or Biomedical Engineering.
• 5+ years of relevant experience in the cell culture media sector, bioprocess or biologics manufacturing, operations, single-use technology industry, and/or research experience preferred.
• High degree of organizational skills (planning, coordinating, tracking) related to time-sensitive creation/production of products in a technical environment.
• Strong cognitive/analytical and strategic thinking skills; confidence and assertiveness to render timely decisions around complex situations.
• Creativity in overcoming obstacles and barriers to progress.
• Proficient in Microsoft Excel, Word, PowerPoint, Outlook, and productivity software.
• Understanding of cGMP.
• Ability to speak, read, and write English.
• Excellent oral and written communication skills.
• Strong interpersonal skills and the ability to maintain/project a positive attitude, especially during difficult situations.
• Ability to work as part of a focused team over extended periods of time.

Pay

For California, the base salary range for this position is $91,105.30 - $118,752.45. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).

Benefits

• Medical, Dental, and Vision insurance
• Life Insurance
• 401k
• Paid Time Off