Fujifilm Manufacturing USA, Inc

Product Specialist II-Bioproduction

Fujifilm Manufacturing USA, Inc • $91K — $118K *
Santa Ana, CA 92704In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
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Job Overview by Ladders

Qualifications

  • Bachelor's, Master's or advanced degree in Life Sciences, Bioengineering or Biomedical engineering
  • 5+ years experience in cell culture media or related fields
  • Strong organizational skills for time-sensitive projects
  • Analytical and strategic thinking abilities for decision-making
  • Creativity in problem-solving
  • Proficient in Microsoft Office and productivity software
  • Understanding of cGMP guidelines
  • Excellent communication and interpersonal skills

Responsibilities

  • Collaborate with internal teams for raw material and packaging qualification
  • Resolve discrepancies in custom raw material evaluation and negotiate priorities
  • Collect and organize user and market requirements for new materials
  • Ensure timely evaluation of new opportunities and communicate feedback
  • Manage communications between product managers and project managers about qualification requirements
  • Host meetings to align progress on product evaluations and qualifications
  • Assess new raw material testing and consolidate pricing information
  • Oversee customer site qualification requests with account managers
  • Maintain and report site qualification status through Power BI
  • Participate in regular meetings to update stakeholders on customer requests
  • Coordinate qualification sample delivery with project managers
  • Initiate and manage site-related change requests
  • Oversee stability study processes for new products and coordinate updates with stakeholders
  • Build relationships across functional areas and enforce a safe communication culture
  • Develop reports and documentation to track progress
  • Monitor and resolve bottlenecks in processes
  • Track key performance indicators effectively
  • Review business processes for efficiency and accuracy
  • Train team members on the site qualification process

Benefits

  • Medical, Dental, Vision insurance
  • Life Insurance
  • 401k plan
  • Paid Time Off
Full 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.

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

About Fujifilm Manufacturing USA, Inc

Fujifilm Manufacturing USA, Inc is a subsidiary of Fujifilm Holdings Corporation, a Japanese multinational conglomerate that specializes in imaging and photography. Fujifilm Manufacturing USA, Inc is responsible for the manufacturing of photographic paper, film, and other imaging products in the United States. The company was established in 1988 and has its headquarters in Valhalla, New York. Fujifilm Manufacturing USA, Inc operates as a subsidiary of Fujifilm North America Corporation.
Learn more about Fujifilm Manufacturing USA, Inc
Size
72,332 employees
Industry
Manufacturing & Automotive
NASDAQ
FUJIF
* Ladders Estimates

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