Chemistry Manufacturing Specialist - Fremont, CA

Sartorius Stedim•Fremont, CA

1d•Onsite

About The Position

At Sartorius, we are seeking a Chemistry Manufacturing Specialist in our Fremont, CA site. In this onsite role, you will perform protein conjugation and formulation of reagents that support Biologics products produced. Your duties will include manufacturing and qualification testing of all protein conjugates, analysis of qualification data and reporting of test results and observations for release. Support cleanroom activities including Biosensor coating, reagent filling and kit packaging activities, as well as support product transfer initiatives.

Requirements

Associate's degree in Biological Sciences or related field with 5+ years of experience, including experience with protein conjugation, is required OR Bachelor of Science in Biological Sciences or related field with 2+ years of experience.
Proficient with Laboratory instruments, SOP’s and documentation/reporting is required.
Effective verbal and written communication required.
Able to work 6am - 2:30pm Monday - Friday

Nice To Haves

Intermediate Excel and data management is preferred
Knowledge of ERP system entry (SAP), part issuance, etc.

Responsibilities

Manufacture and conduct qualification testing of conjugates to support Fremont and Shanghai Operations.
Formulate buffers, calibrators, reagent kits, preservatives and all ancillary reagents used in Consumables Manufacturing according to Standard Operating Procedures.
Test and verify buffers for the next stage of production.
Perform data analysis to report test results.
Maintenance of conjugate database and presenting quarterly review of trend charts.
Perform incoming quality control (IQC) of raw materials for production use.
Maintain inventory of materials (raw & semi-finished) needed for production.
Manage lab supplies inventory and support cycle count initiatives.
Review and manage the shelf-life data of raw chemicals upon receipt.
Report material non-conformities at any stage of the process and assign NCOR numbers.
Update part specifications through DIR releases.
Work alongside Scientist with hands on troubleshooting, compiling data and communicate test results in different forums.
Learn new manufacturing processes for new and/or acquired products; manufacture parts as required as part of the Transfer and then on-going Manufacturing; other duties as required.
Maintain up to date calibration of equipment used in Chemistry Manufacturing and Consumables Manufacturing.
Responsible for maintaining/updating EHS requirements within the CONS/Chemistry Manufacturing Lab.
Support hands on waste management activities.
Act as the liaison between PD, NPI and Operations for the hands-on execution of the transfer process, specific to Chemistry manufacturing.
Participate in other Chemistry/Consumable related activities, as needed.

Benefits

Mentoring, leadership programs, internal seminar offerings
Paid vacation, sick time, corporate holidays and community service day; as well as flexible work schedules
Comprehensive onboarding, including a virtual online platform
Mutual support, team spirit and international collaboration; communities on numerous topics such as “Coaching”, “Agile Working” and a “Businesswomen’s Network”
Wide selection of health and well-being support such as a variety of medical plans to choose from, dental, vision, EAP, and other wellness programs.
Working in smart buildings with the latest technology and equipment.
401 k (with generous company match)
HSA, FSA (dependent care & healthcare spending), Transportation Commuter Account
Basic Life Insurance, AD&D, EAP, Family Planning & Women’s Health, Health Advocate
Supplemental Life Insurance (employee, spouse & dependents), Legal Services, LTD & STD, Critical Illness Insurance, Student Loan Tuition Refinance Service