Manufacturing Scientist Details

Manufacturing Scientist

Adaptive Biotechnologies - South San Francisco, CA

Employment Type : Full-Time

We are powering the age of immune medicine- you can too. At Adaptive, our goal is to meaningfully improve people's lives by learning from the wisdom of the adaptive immune system.

As an Adapter, you will be surrounded by driven colleagues who think boldly to pursue ground-breaking innovation. You will experience meaningful challenge in your work and be fueled by motivating energy knowing you make a difference in people's lives.

You belong here- come discover your story at Adaptive.

Position Overview

The Manufacturing Scientist I is responsible for the manufacture of laboratory reagents under GMP processes. Works within the Drug Discovery Operations team to provide high quality, regulated reagents for use in the personalized T cell therapy product. Leads and prepares reagents and controls and assists with kitting activities for Tech Transfers. Trains new and junior team members on Manufacturing processes. Participates in troubleshooting and investigations, acts as an SME on processes, nonconformances and CAPAs. Participates in the authorship of SOP's and process improvement initiatives. Anticipates and plans for upcoming work. Maintains audit readiness and identifies compliance improvements while maintaining Manufacturing efficiency. Assists with training schedule, anticipates upcoming work and plans daily Manufacturing activities. Drives drive the completion of Manufacturing work by prioritizing and communicating cross-functionally. Maintains audit readiness and identifies and implements compliance improvements while maintaining Manufacturing efficiency.

Key Responsibilities and Essential Functions

The Manufacturing Scientist I will be responsible for the manufacture of laboratory reagents under GMP processes. The successful candidate will work within the Laboratory Ops team to provide high quality, regulated reagents for use in the Production Laboratory.

Responsibilities:

• Perform reagent manufacturing under Good Laboratory Manufacturing Practice (GLP) batch records
• Author and manage SOPs and Master Batch Records (MBRs) related to manufacture and labeling of reagent sub-components and final components, and in compliance with necessary regulations (GLP, ISO, etc.)
• Ensure laboratory compliance with regulatory agencies and health authorities
• In collaboration with Supply Chain, QC, Research and Development, Drug Discovery Operations, and QA, execute the ordering, testing, labeling, and releasing of reagent sub-components, and final components
• Develop new methods for improving reagent assembly and work with Process engineering team on automated methods
• Contribute and/or lead key strategic project to optimize manufacturing processes and increase throughput while ensuring regulatory compliance
• Enter and track lot information in laboratory information (LIMS) and ERP systems
• Ensure proper maintenance, calibration, and function of laboratory instruments and equipment
• Ensure training for Manufacturing Associates are current and completed in a timely matter
• Manage the inventory of raw materials and finished goods, highlighting any issues that may impact the overall production timeline
• Lead investigation to identify root cause and implement corrective/preventative actions

Qualifications

• BS degree in Biology, Molecular Biology, Immunology or Medical Technologist from an accredited institution.
• 3 to 5 years of laboratory experience in a regulated manufacturing setting.
• In-depth experience with molecular biology skills (PCR, RT-PCR, next-generation DNA sequencing)
• Experience with and/or working knowledge of immune-based assays
• Demonstrated ability to manage projects cross-functionally across different departments
• Flexible work hours during weekends or swing shift
• Working knowledge of laboratory terminology, equipment and supplies
• Ability to maintain organized, detailed records and produce accurate reports
• Strong planning, organization, analytical, and leadership skills
• Ability to interact constructively with peers and support groups
• Advanced computer skills including Excel and Word
• Innovative thinking and strong problem-solving skills
• Strong interpersonal and communication skills, both written and spoken. Capable of consolidating and presenting information to technical, executive, customer, and peer-group audiences
• The ability to be self-motivated and work independently, with minimal supervision, while also working as part of a team environment in a dynamic organization.
• Experience working in either a clinical (CLIA/CAP), high-throughput or manufacturing environment
• Experience with MRP/ERP software for tracking and documentation (e.g. NetSuite)
• Experience with laboratory automation

Working Conditions

Flexibility and willingness to work in excess of standard hours when necessary, including nights & weekends

Physical Requirements

Able to lift 10 pounds and work in -20C walk-in freezer

Where permitted by applicable law, applicant must have received, or be willing to receive, a COVID-19 vaccine by date of hire to be considered for employment.

Adaptive Biotechnologies is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Opportunity Employer/Veterans/Disabled

NOTE TO EMPLOYMENT AGENCIES: Adaptive Biotechnologies values our relationships with our Recruitment Partners and will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Adaptive Biotechnologies is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Adaptive Biotechnologies who is not a member of the Human Resources team.