Bioproduction Product Specialist II

FUJIFILM Holdings America Corporation; Dyer (CA); Hybrid; USD 91,000 - 119,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401k

Paid Time Off

Job summary

FUJIFILM Biosciences seeks a Product Specialist II to support onboarding of new products and site qualifications. You will manage qualification of new raw materials, packaging, and stability study requests, coordinating with cross-functional teams.

Ideal candidates hold 5+ years in cell culture media or bioprocess industries, with strong organizational and communication skills and proficiency in Office tools.

Qualifications

• Bachelor's, Master's or higher in Life Sciences or related field.
• 5+ years in cell culture media, bioprocess, or biologics contexts.
• Strong organizational and communication skills.
• Proficiency with Excel, Word, PowerPoint and Outlook.
• Understanding of cGMP and regulatory expectations.

Responsibilities

• Collaborate with internal teams to progress qualification of new raw materials and packaging components for new products.
• Manage site qualification requests and coordinate with Sales/Global accounts.
• Maintain site qualification status updates on Power BI and provide monthly reports.
• Provide stability study quotes and oversee related documentation.
• Serve as SME for raw material and site qualification processes.

Skills

5+ years experience

Cell culture media

Bioprocess manufacturing

Biologics operations

Single-use technology

Microsoft Excel

Microsoft Word

PowerPoint

Outlook

Education

Bachelor's/Master's in Life Sciences/Bioengineering

Tools

Power BI

Job description

Position Overview

Position Description

We are hiring a Product Specialist II. The Product Specialist II will support custom business function for on-boarding new products and/or new site qualification. They will manage the qualification of new raw materials such as new chemicals and/or packaging, customer new site qualification and process new stability study requests.

Company Overview

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.

Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Biosciences.

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 of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

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 in the efforts to prioritize actions required to 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 providing feedback to customer within a target turnaround


• Manage communication between internal team, product managers and CXT project managers on new raw material qualification requirements and provide timely updates to relevant stakeholders


• Host routine forum/meeting that ensures alignment and progress of new product evaluation and raw material qualification among key functional departments


• Collaborates 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 weekly / bi-weekly meetings with relevant stakeholders i.e. Sales, QA team, CXT or LSM teams to obtain updates and align on new customer requirements and/or requests


• Collaborate with CXT Project managers on qualification sample requests, ensuring timely delivery of such 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 stability study process for new products: Provide stability study quotes to Sales, oversee new part number set up, work with QC and Territory Managers to provide timely updates, protocols, interim reports, and final reports, work with Customer Service to ensure invoices are prepared on time


• Must have proven ability to build relationships and guide teams which 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 implementing 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 SME for raw material and site qualification process, provide training to sales team or other new members of the team

Required Skills/Education:

• Bachelors, Masters or advanced degree in Life Sciences (Biology, Chemistry), Bioengineering or Biomedical engineering fields


• 5+ years relevant experience in 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 used 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.


• Must have excellent oral and written communication skills


• Strong interpersonal skills and the ability to maintain/project a positive attitude, especially during difficult situations.


• Requires the skill to work as part of a focused team over extended periods of time.

Salary and Benefits:

• 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.).


• Medical, Dental, Vision


• Life Insurance


• 401k


• Paid Time Off

*#LI-Hybrid

EEO Information

Fujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).