Manufacturing Process Chemist
SUMMARY Responsible for manufacturing, QC testing, process improvements, supporting development and validation for LDTs
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Collaborates and communicates with Planning, Quality Systems, R&D, and Supply Chain
- Carries out manufacturing, in-process testing, final QC testing following established business policies and procedures
- Required to complete, review, and maintain manufacturing / QC batch records, DHRs, and records per CLIA/CAP guidelines and write technical reports when appropriate
- Assists with technology transfer of new LDTs including process validation and equipment IQ/OQ
- Draft and revise documentation by change control including SOPs, MRPs, and specifications
- Support the QTP, validation, stability, deviation, NCMR, and CAPA systems as a team contributor or lead
- Participate with establishing raw material requirements, labor routings, BOM, and applicable manufacturing / QC procedures
- Independently identifies opportunities for process improvements to increase quality and reduce costs and inefficiencies
- Investigates issues with the ability to identify root cause and implement corrective actions
- Collaborate with supervisor to establish objectives, milestones, and timelines for completion and execute projects with limited supervisory responsibilities
- Maintain reagent inventories, supplies, and organization of the laboratory
- Provides training, guidance, and leadership to departmental personnel
- Follows company policies, safety procedures, and industry regulations
SUPERVISORY RESPONSIBILITIES This job has no supervisory responsibilities
QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
- BA or BS in Chemistry, Biological Sciences, and 2+ years of related experience in a GMP and/or CLIA/CAP environment and
- Previous training and experience in the operation of laboratory equipment and use of laboratory chemicals and tools
- Read and interpret documents such as, reagent specifications, safety rules, operating and maintenance instructions, and procedure manuals
- Write procedures, technical reports, and slide decks
- Effectively communicate in a one on one and small group situation
- Understand good laboratory practices and good documentation practices
- Add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals
- Apply concepts such as fractions, percentages, ratios, and proportions to practical situations
- Working knowledge of SPC and basic biostatistics tools preferred
- Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form
- Perform multiple tasks and adapt in a fast-paced environment
- Understand and comply with written procedures and cGMP
- Good organization skills and keen attention to details are required
CERTIFICATES, LICENSES, REGISTRATIONS None required
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit for extended periods of time in front of a computer monitor. The employee is frequently required to use hands to finger, handle, or feel. The employee frequently is required to stand walk, sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. The employee may be asked to lift and/or move, with assistance, up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and extreme cold. The noise level in the work environment is usually moderate with background sounds from instruments and freezers.
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.