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Senior Process Group Chemist

Carlsbad, CA 92008

Posted: 12/27/2022 Employment Type: Direct Placement Category: Chemists and Materials Scientists Job Number: 95831

Job Description

The Senior Process Group Chemist assists in coordinating the planning and scheduling efforts of the production schedule in support of the specific product line(s). This involves ensuring the timely manufacture of the specific product line(s) as per the production schedule and coordinating the resolution of technical or other issues in a timely fashion. The position maintains all Statistical Process Control (SPC) and other product specific data, investigates the root cause of any notable data points and ensures compliance to all Quality standards, policies, and procedures. The Senior Process Group Chemist trains and evaluates employees on product-specific processes and procedures and is responsible for financial accountability to manufacturing standards, yields, and scrap.

  • Manufactures (i.e. Formulates bulks, and Quality Controls) products (i.e. Lateral flow devices, controls/calibrators and microtiter systems) while adhering to regulatory requirements and business polices /procedures and schedules
  • Provides training to chemistry staff on Manufacturing Instructions and Standard Operating Procedures (SOP)
  • Coordinates the activities of the Chemists working on product-specific work orders
  • Displays leadership by assessing issues affecting departmental performance, Quality standards, and product quality, communicates to management then initiates appropriate corrective action
  • Reviews completed Device History Records and performs financial reviews of work orders then initiates appropriate corrective action through Engineering Change Orders (ECO)
  • Ensures product is completed on schedule and may participate in development of the weekly production schedule
  • Write /revises documentation as required to improve product-specific processes then implements corrective actions as necessary to address documentation and process issues
  • Assists with the review and implementation of ECO’s

The Senior Process Group Chemist will interact with the following groups/systems:
  • Inventory Control – obtains/returns materials, resolves material variances related to work order usage
  • LN – reconciles work orders, enters/checks labor hours, checks material availability, BOM’s, general manufacturing queries, and closes work orders; prepares work order variance reports
  • Process Engineering – technical troubleshooting, product transfers
  • Production – coordinates optimization/matrix assembly
  • Planning – updates Chemistry Manufacturing schedules
  • R&D - participate in product transfers, validations, resolution of technical issues
  • Quality/Documentation – ECO’s, NCMR’s, deviations, validations, QTP's, investigation reports

The work environment characteristics are representative of a laboratory environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines.

Position requires ability to lift up to 20 lbs. on a regular basis. Up to 75% of time at lab bench or desk, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted.

  • B.S./B.A. Life/Applied Sciences or equivalent experience preferred
  • Minimum 5 years of related work experience in a GMP environment preferred

  • Technical expertise in the specific product
  • Competent in all manufacturing procedures related to the specific product
  • Basic algebraic, statistical and mathematical skills
  • General computer knowledge and experience with EXCEL or equivalent programs
  • Specific computer knowledge related to the ERP program
  • Proficient in data analysis, data summary, and presentation
  • Good organizational skills
  • Laboratory skills, such as protein purification, antibody conjugation, solution preparation, ELISA experience, assay development skills, knowledge of experimental design etc.
  • Good verbal, written and interpersonal communication skills
  • Knowledge of QSR’s and ISO 13485

We are proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/ Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

SALARY: $70,720 - $95,860

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