Upstream Lead Manufacturing Associate
Upstream Lead Manufacturing Associate
The Lead Manufacturing Associate is primarily responsible for assuming a leadership role in the context of the production of bulk vaccines in accordance with cGMP documentation to meet the production schedule and goals of the site. Operations focus on Upstream Cell Culture activities including unit operations of Static and Dynamic Cell Culture, Microcarrier Separation and Concentration. The candidate will also conduct general GMP operations as needed to support activity including equipment assembly, solution preparation, operation of autoclaves, and parts washing. Knowledge and experience of aseptic behavior is a benefit to the candidate. Responsible for operating in a safe and compliant manner, to ensure production goals are met.
- Assumes a lead role in the production processes for bulk vaccine manufacturing in accordance with cGMP documentation for Upstream Cell Culture activities including unit operations of Static and Dynamic Cell Culture, Microcarrier Separation and Concentration. Ability to operate manual, semi-automated, and automated equipment in support of routine production under supervision.
- Reports regular status of production operations to both management and production team.
- Works with other departments and personnel on projects related to licensed process including Validation, Facilities, M-Tech, and Quality groups.
- Demonstrates expertise on some or all related areas of licensed process.
- Ensures all training requirements are completed per the standards set forth by the site.
- Maintains a cGMP ready state of production facility. All work is documented compliantly within logbooks and batch records in accordance with good documentation procedures.
- Contributes to the quality compliance aspect of the needs of the department in the areas of document revision, deviation report writing and assisting in the execution and implementation of change controls.
- Identifies any procedural issue including process deviations, troubleshoots issues immediately, and assists with investigation and potential corrective actions to quality incidents.
- Acts as SME or system owner for specific pieces of equipment and procedures. The candidate will assist supporting departments by contributing towards the execution of maintenance, validation, and qualification of equipment and procedures as necessary.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
EDUCATION, EXPERIENCE & SKILLS:
- Bachelor’s Degree in a scientific discipline required. Substitution of Associate’s Degree, Program Certificate, or High School Diploma will be assessed based on additional experience working in a GMP biopharmaceutical/ biotech production environment.
- A minimum of 3-5 years of related experience in a GMP biopharmaceutical/ biotech production environment.
- Must have a technical understanding of equipment and operations common to executing procedures in support of cGMP FDA licensed manufacturing area.
- Must be quality focused with knowledge and understanding of cGMP quality systems and their application to manufacturing operations.
- Ability to maintain and operate common laboratory equipment such as pH meters, conductivity meter, filter integrity tester, scales, pumps, and autoclave.
- Excellent written and verbal communication skills.
- Must be a team player and able to work cross-functionally in a matrixed environment.
PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
- General math skills required, including algebra.
- Ability to perform multiple tasks as assigned, with flexibility to work according to the production schedule including weekends and holidays.
- Must be experienced with Microsoft Word and Excel.
- Requires vaccination against different viruses including Vaccinia Virus and Japanese Encephalitis Virus.