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.
- General Helper in Acton MA
- Wire Harness Assembly Specialist in Hudson NH
- Quality Management System Coordinator in Hudson NH
- Assembler 2 in Hudson NH
- Vial Capper Machine in Vineland
- Mid Day Forklift in Bridgeton
- Electronic Assembler in Alpharetta GA
- Fire Protection and Detection System Designer in Wilmington NC
- Inventory Control Clerk 1 in Olive Branch MS
- Accounts Receivable in Memphis TN
- Assembler in Ayer MA
- Maintenance Supervisor in
- Warehouse Associate in Oxford MA
- CNC Machinist in
- Electrical Engineering Technician in Plymouth MN
- Engineering Technician Sr in Plymouth MN
- Mechanical Engineering Technician in Plymouth MN
- Surface Mount Machine Technician in New Hope MN
- Electronics Assembler in New Hope MN
- Quality Engineer in Dawsonville GA
- IT Operations Engineer II in Milford MA
- Unit Manager in Newnan GA
- Sanitation Operator in
- Technical Service Technician 1 in Chelmsford MA
- Engineer in Plymouth MN
- Engineer in Plymouth MN
- Incoming Inspector in Merrimack NH
- Customer Service in
- Technician in Chaska MN
- Tooling Engineer in McBee SC
- Entry Level Maintenance Mechanic - Sanitation Technician in
- Material Handler 1st shift in Westborough MA
- Quality Inspector II - EM OR RII in Westborough MA
- Software Engineer in Suwanee GA
- Field Application Technician in Duluth GA
- MRB Coordinator in Westborough MA
- Quality Control Technician in Carlsbad CA
- Quality Engineer in
- Quality Tech in Memphis TN
- Assistant Traffic Manager in Galloway TN
- Customer Service Representative in Suwanee GA
- EM Assembly in Alpharetta GA
- Laser Machine Operator 2nd Shift in Flowery Branch GA
- Operations Manager in Southborough MA
- Electrical Assembly Technician in Suwanee GA
- Business Development Manager in Attleboro MA
- Tech Support Engineer (Data Operations Manager) in Portsmouth NH
- Lead Human Factors Engineer in Portsmouth NH
- CNC Programmer in Alpharetta GA
- Machine Operator - 1st & 2nd Shift in Newton MA
- Americas Demand Generation Coordinator in Milford MA
- Material Handler II in Milford MA
- Production Chemistry Technician II in Golden CO
- Mechanical Designer in Alpharetta GA
- Assembler I, 1st Shift in Fitchburg MA
- Panel Wiring Technician in Alpharetta GA
- Service and Repair Technician in Oakdale MN
- Rollomatic Operator in Memphis TN
- Rollomatic Setup Tech (LEAD) in Memphis TN
- CNC Turning Center Operator in Memphis TN
- CNC Turning Center Lead in Memphis TN
- Mechanical Engineer in Merrimack NH
- Controls Engineer in Jasper GA
- Controls Engineer in Spartanburg SC
- Warehouse Operator in Natick MA
- BTO Large Operator in Natick MA
- Embedded Software Engineer in Portsmouth NH
- Systems Engineer in Portsmouth NH
- Repair Technician in Amherst NH
- Program Manager in Ham Lake MN
- Recruiter in Clear Water MN
- Packer in Lawrenceville GA
- Machine Operator III in Keene NH
- Fleet Manager in Everett MA
- 3rd shift Maintenance Technician in Fairburn GA
- Accounts Payable Coordinator in Milford MA
- Customer Service in Memphis TN
- Material Handler in Londonderry NH
- Stockroom 1st Shift in Gainesville GA
- Stockroom- 3rd Shift in Gainesville GA
- Continuous Improvement Engineer in Newnan GA
- Sales Engineer in Suwanee GA
- Field Service Engineer in Suwanee GA
- IT Coordinator in Memphis TN
- Director, Program in Brooklyn Park MN
- Program Manager in Chaska MN
- Project Design Engineer in Gainesville GA
- Design Assurance Engineer in St. Paul MN
- Accounting Admin in Gainesville GA
- Picker-2nd Shift in Lawrenceville GA
- Forklift Operator-1st shift in Lawrenceville GA
- Picker-1st Shift in Lawrenceville GA
- Quality Inspector in Alpharetta GA
- Solderer in Hudson NH
- Molding Process Engineer in Clover SC
- Shipping and Receiving - 1st shift in Mount Laurel NJ
- SMT RMA in Nashua NH
- Shipping - 1st Shift in Vineland NJ
- Field Service Technician in Midwest
- Mechanical Technician in Bedford NH