Consumables Program Manager
Asahi Kasei

Glenview, Illinois

This job has expired.


At Asahi Kasei we believe anyone can buy equipment or build a facility. It is our diverse team members around the globe who will enable us to develop ideas and technologies and capture the exciting opportunities that lie ahead. We look for candidates with a fresh perspective, people with a wide variety of skills who are creative thinkers, enjoy challenges and are driven to excel.

We are currently seeking applications to fill the following job opening at Asahi Kasei Bioprocess where we sell Planova® virus removal filters and develops and manufactures related bioprocess equipment.

Company:
Asahi Kasei Bioprocess America, Inc.

Job Description:

Asahi Kasei Bioprocess (AKB) provides pharmaceutical and biopharmaceutical manufacturers with a comprehensive suite of tools to maximize safety and improve yields of biotherapeutics during research, clinical and commercial-scale production. PlanovaTM virus-removal filters anchor a diverse product portfolio defined by quality, consistency and scalability. Additional areas of expertise include liquid chromatography, inline buffer dilution and oligonucleotide synthesis.

We are a growing team (140+) of professionals excited about what we do and our ability to impact healthcare delivery systems worldwide. We offer a "big company" benefits package and a "small company" culture and work environment. Every employee at Asahi Kasei Bioprocess America can impact our future.

As an Asahi Kasei Bioprocess America employee, you will enjoy:

  • Competitive compensation with bonuses
  • Great health and wellness benefits with the company paying over 80% of insurance premiums
  • Paid time off
  • Strong company match to 401(k) contributions
  • Tuition reimbursement program

Position Summary:
We are currently looking for a Consumables Program Manager to join our team at Asahi Kasei Bioprocess! The person in this role will manage all aspects of AKBA consumables products, including single-use tubing set kits and consumable components and spare parts for AKBA capital equipment products (e.g., seals, O-rings, frits, etc.). This role will work closely with the R&D team to develop new products, will develop into the in-house subject matter expert on our consumable products, and will manage continuity of supply with support of the Purchasing and Order Fulfillment Departments. Customer service will also be a key aspect of this role as the Consumables Product Manager will field technical questions, inquiries, and complaints from customers on these products and will facilitate communication between AKBA and consumables customers.

Responsibilities:
  • New Product Development for Single-Use Products
    • Working with the R&D team on new single-use product development (including shelf life evaluation, material evaluation, part numbering/naming, label review, packaging development, etc.)
    • Working with stakeholders to create new internal processes for production of new products
    • Managing & facilitating FMEA processes and design reviews for new single-use products
    • Maintaining regulatory knowledge and ensuring that AKBA's new single-use products in development adhere to currently applicable regulatory guidelines

  • Documentation
    • Creating and maintaining customer-facing memos and statements relating to consumable product specifications, etc. (e.g., shelf life, animal ingredients, etc.)
    • Developing and maintaining validation reports/guides (containing material specifications & testing results, etc.) for consumable products
    • Reviewing and approving internal and external technical documentation (including drawings)

  • Supplier Management
    • Working with QA to evaluate potential new consumables-related vendors
    • Working with QA to evaluate impact of vendor material & other changes relating to consumable parts (reviewing and approving vendor changes, including drawing revisions)
    • Supporting QA on consumables supplier audits and relationship building with suppliers
    • Supporting QA with review of consumables supplier Quality Agreements
    • Coordinate with consumables suppliers and key AKBA stakeholders (Eng,Sales , Quality) for product and process improvements
    • Coordinate discussion with consumables suppliers and Purchasing,and Sales to establish formal sales agreements on a annual basis.
    • Working with consumables suppliers (including sub-suppliers/manufacturers of components used in our assemblies) on technical questions, qualification of alternate components, product enhancements and improvements.
    • Coordinate with suppliers to assure the optimum product design and material availability to meet the needs of: 1) the customer's requirements, 2) the system design 3) the suppliers field of expertise
    • Supporting QA with consumables supplier deviation, NCMR, and CAR management

  • Customer Communication
    • Responding to technical customer questionnaires and inquiries relating to consumable products
    • Draft and/or review technical content for customer change notifications related to consumables products
    • Communicating order timing (delays, planned delivery dates, etc.) to customers
    • Handling customer complaints relating to consumables products
    • Collaborate with Marketing to gather feedback and information on consumable products in use at customer sites
    • Participate in Industry Groups (ie, BPSA, ISPE, Biophorum)

  • Product & Process Management
    • Maintaining regulatory knowledge and ensuring that AKBA's currently sold consumable products adhere to currently applicable regulatory guidelines
    • Working with internal stakeholders for product and process improvements
    • Turning "open order reports" generated by AKB Purchasing team into proactive communication with customers
    • Facilitating internal project team meetings, ensuring interdepartmental communication regarding consumables products
    • Supporting Sales on customer forecasting for consumable products
  • Additional projects as assigned.

Qualifications/Requirements:
  • BS/BA degree in scientific, technical, or management; Engineering preferred
  • 5+ Years working experience in bioprocessing or other highly-regulated industry (e.g., medical device, food safety, aerospace)
  • Single-use / elastomeric and plastic consumable product working experience required
  • Innately curious and growth mindset
  • High energy and excellent time management
  • Demonstrated ability to solve unique and complex problems; demonstrated critical thinking and analytical skills
  • Decision-making confidence with regard to logistics challenges
  • Excellent communicator and collaborator
  • Proven experience with GMP and GDP
  • Working knowledge of basic quality tools (i.e., root cause analysis, FMEA)
  • Other preferred knowledge / experience:
    • Aseptic process knowledge
    • Customer service experience
    • Quality engineering experience
    • Materials/supply chain management experience

Physical Demands/Environmental Conditions:
  • Ability to travel domestically and internationally. Approx. 10-15% of the time
  • Position located in Glenview, IL. Flexible work schedule and hybrid work-from-home to be considered after 6-month on-boarding.

#LI-MG1

We believe a diverse workforce is crucial to our growth as a global supplier of advanced materials. Asahi Kasei is an equal opportunity employer.


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