• Job Description

  Req#: 202403-107846

  Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

  The Position

  A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.

  Creating a world where we all have more time with the people we love.

  That’s what makes us Roche.

  Roche is dedicated to evolving the practice of medicine and helping patients to live longer, better lives. Our operations are critical to the success of our company and our impact on society. As a Manufacturing Formulator you will be part of an industry-leading organization helping patients to obtain on-time and reliable diagnostics. Doing now what patients need next.

  The Manufacturing Formulator collaborates to produce reliable medical device products and supplies with effective operations in an empowered organization. As part of a dynamic team, the Manufacturing Formulators, responsibilities include performing weigh, mix and in process testing of chemical reagents in a regulated environment, through the manual processing or operation of automated equipment.

  Manufacturing Formulator recognizes and elevates safety, equipment, and product problems, contributing to the achievement of production goals. Utilizes validated software and systems to maintain processes, batch records, and inventory control. Ensures all production related documentation is in compliance with quality system regulations. May be responsible for low complexity training of new employees and sharing best practices. They must have good communication and organizational skills and the ability to identify opportunities that would drive the business forward.

  Your opportunities:

  Production (70%)

  • Follows work instructions to formulate and document production of stocks and bulk solutions by performing calculations, completing material requests and transactions, and utilizing lab equipment in controlled areas.
  • Performs in-process testing of reagents as detailed in manufacturing formula and standard operating procedures.
  • Supports team members with verifications including concentrations/titers, line clearance, and line closeout.
  • Fulfill reservations by proactively checking open reservations, requesting material, pulling material aliquot and properly labeling material.
  • May assist in the execution of validations, protocols, and scientist investigations.
  • Contributes to the manufacturing schedule by supporting at least 2 reagent product lines (detection, molecular, special stains, antibody, bulk reagents)
  • Utilizes validated production systems as part of manufacturing documentation and inventory management.

  Safety and Quality (15%)

  • Maintain Right to Operate and ensure that all processes are performed in a safe and healthy manner; Address and escalate any potentially unsafe hazards; Timely reporting of safety hazards, incidents and near misses using safety reporting tools.
  • Navigate and understand the quality system and escalate issues
  • Accurately performs tasks in a regulated environment (OSHA, NMPA, FDA, etc.)
  • Performs and documents all transactions and production instructions with accuracy related to the proper receipt, quarantine, storage, and disbursement of materials as it relates to FDA, OSHA, QSR, ISO, Good Manufacturing Practices and other Roche policies and procedures.
  • Assists with non-conformance investigations, reworks, and corrective actions.
  • Participates in the review of and provides feedback on document changes, including redlines
  • Adhering to 95% or above internal training compliance
  • Responsible for maintaining calibrated equipment

  Teamwork and Collaboration (10%)

  • Proactively collaborates with peers on shift and with other function to ensure daily targets are achieved.
  • Assist in the successful onboarding of new employees and contractors.
  • May collaborate with cross-functional teams on new production processes.

  Continuous Improvement (5%)

  • Responsible for 6S activities, gathering/meeting cycle times and developing/following standard work; identifies and implements process improvements and continuous improvement initiatives utilizing lean tools.
  • Participates and contributes in tier meetings.
  • May participate in the collection of data for daily metrics purposes and to support operational excellence initiatives and improvements.
  • Participates in process improvement projects.

  Other duties as assigned.

  Who you are?

  Education/Experience:

  • High School Diploma with 2 year relevant work experience (required)
  • Associate’s Degree with 1 year relevant work experience (preferred)
  • Experience in regulated industry (preferred)
  • Experience in GDP/GMP (preferred)

  Knowledge Skills and Abilities :

  • Knowledge of basic and some specialized laboratory techniques
  • Experience in accurate and precise manual pipetting and measuring techniques
  • Experience with handling corrosive and hazardous materials
  • Demonstrated experience with Lean / Continuous Improvement
  • Experience with Google products (gMail, gSheets, gDoc, etc), preferred
  • Experience with ERP systems required
  • Ability to read, write and comprehend English
  • Ability to work with cross-functional teams
  • Ability to be agile and accurate in a high-volume environment
  • Strong organizational skills, planning skills and attention to detail
  • Strong communication skills - written, verbal
  • Strong critical thinking, problem solving and analytical skills
  • Excellent time management skills to manage multiple tasks and competing timelines
  • Ability to use the technology associated with the industry.
  • Ability to use precision tools
  • Ability to have prompt, regular and reliable worksite attendance.
  • Ability to work effectively with a respirator and other required PPE
  • High degree of initiative with the ability to work under general supervision

  Physical conditions and PPE requirements:

  The physical demands described are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Required to stand, walk, sit, kneel, bend, crouch for a combined 4 or more hours per day.
  • Required to push, pull, and lift a minimum of 50 pounds. Repetitive, consistent movements of the wrists, hands, and/or fingers. The worker is required to have good near visual acuity to perform activities throughout the processes in the assigned area.
  • Must be able to work in, on, around, over and under fixed equipment and machinery; to manipulate heavy equipment, tools and supplies; to concurrently manipulate multiple controls and machinery; and to wear and work in personnel protective equipment.
  • This is an essential position supporting the organizational goals requiring attendance on weekends, holidays and during emergency or exceptional conditions.

  Relocation benefits are not available for this job posting.

  Who we are

  At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

  Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.

  Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

  If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants .

• About the company

  606018 F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics.

Notice