Lead a third‑shift team in downstream biomanufacturing of biologics drug substance in a cGMP environment, ensuring compliance, schedule adherence, and continuous improvement.
Responsibilities
Lead and manage a 3rd‑shift team of 5‑15 staff
Ensure GMP compliance and production schedule adherence
Coordinate with QA, MS&T, Engineering and other support functions
Drive continuous improvement and standard work
Conduct performance reviews, hiring, and salary reviews
Requirements
Doctorate Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 3 years of relevant experience
Masters Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 6 years of relevant experience
Bachelors Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 7 years of relevant experience
Associates Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 9 years of relevant experience
High School Diploma with a minimum of 10 years of relevant experience
Oversee a team/shift responsible for Downstream manufacturing of biologics drug substance, supporting direct execution and providing leadership oversight.
Responsibilities
Ensure batch manufacturing readiness
Meet production schedule deliverables
Drive a continuous improvement culture
Support Person In Plant (PIP)
Continually optimize staff and operating model
Requirements
Doctorate Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 3 year of relevant experience
Masters Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 6 year of relevant experience
Bachelors Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 7 year of relevant experience
Associates Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 9 year of relevant experience
High School Diploma with a minimum of 10 year of relevant experience
Oversee a team/shift responsible for Downstream manufacturing of biologics drug substance, supporting direct execution and providing leadership oversight.
Responsibilities
Ensure batch manufacturing readiness
Meet production schedule deliverables
Drive a continuous improvement culture
Support Person In Plant (PIP)
Continually optimize staff and operating model in support of client program requirements and site financial objectives
Requirements
Doctorate Degree in a scientific, engineering or biomanufacturing discipline
Masters Degree in a scientific, engineering or biomanufacturing discipline
Bachelors Degree in a scientific, engineering or biomanufacturing discipline
Associates Degree in a scientific, engineering or biomanufacturing discipline
Process development scientist to join the guide‑RNA (gRNA) process development team, contributing to gRNA drug substance process development for programs in clinical development.
Compensation
Compensation: $32.00-$41.00 per hour
Responsibilities
Synthesize, purify, and characterize gRNAs to develop drug substance manufacturing processes and controls
Execute solid‑phase synthesis and purification experiments to support process development, scale‑up, and transfer of oligonucleotide drug substance manufacturing
Execute routine analytics including HPLC and UV‑Vis
Prepare buffers, reagents, and stock solutions used for process development activities, following established recipes and SOPs
Compile and present data to team members and key stakeholders
Requirements
B.S./M.S. degree in chemistry, chemical engineering, or biochemistry (or related field)
Nice to have: background in CRISPR gRNA development
An operator is responsible for performing and documenting all tasks and activities associated with biologics manufacturing at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility.
Compensation
$2,500 sign-on bonus eligible!
Responsibilities
Prepare, sterilize, inoculate, and monitor single-use bioreactors and seed-train vessels
Execute sterile media/feed preparation and aseptic sampling for cell count and viability
Set up, operate, and sanitize automated chromatography skids, depth filtration, viral filtration/inactivation, and Tangential Flow Filtration (TFF/UFDF) systems for mAb isolation and purification
Execute and monitor core mAb manufacturing processes (media/buffer prep, upstream/downstream processing, formulation, fill/finish, secondary packaging)
Maintain cGMP compliance in a regulated environment (USDA/FDA/EMA)
Conduct purification and analytical testing using large-scale lab equipment, while supporting lab operations, documentation, and cross-functional collaboration.
Responsibilities
Protein purification
Buffer preparation & formulation
Column packing
Tangential Flow Filtration (TFF)
Sample management (aliquot preparation)
Requirements
Bachelor's degree in Science or other related degree concentration
Provide hands‑on experimental and operational support for gene therapy downstream process development, including purification, filtration, chromatography, and batch execution.
Responsibilities
Plan, execute, and analyze assigned experiments
Perform downstream process operations such as depth filtration, chromatography, and TFF
Support pilot and large‑scale batch execution
Compile and analyze experimental data
Document procedures and results
Requirements
Bachelor’s degree in biological sciences, pharmaceutical sciences, chemical engineering, or a related technical field
Support Ultragenyx’s state-of-the-art GMP manufacturing gene therapy manufacturing facility in Bedford, MA, focusing on Downstream and central services manufacturing processing.
Compensation
$25—$30 USD
Responsibilities
Attend daily manufacturing tier 1 meetings and be prepared to communicate current operation status
Generates / Reviews / Approves new and current SOP’s, batch records, and/or protocols in support of the equipment and manufacturing processes associated with the Downstream and Central Services manufacturing areas
Supports quality investigations, continuous improvement efforts and engineering activities as they directly impact the functionality of the manufacturing areas
Ensure maintenance, upkeep, and organization, of the facility and processes within the Downstream and central services manufacturing areas
Support the execution of all activities in compliance with environmental health and safety (EHS) requirements, and good manufacturing procedures (cGMPs)
Vaxcyte is looking for a Sr. Engineer with experience in campaign support, tech transfer, and GMP/regulatory authoring to join the Conjugation engineering team.
Compensation
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $170,000 - $198,000 (SF Bay Area). Salary ranges for non-California locations may vary.
Responsibilities
Lead all pre-commercial CDMO TFF and filtration operations across our conjugation network, and provide technical support to our commercial operation partners
Contribute to CMO manufacturing preparation and oversight via document authoring, document review, person in plant responsibilities, and troubleshooting when necessary
Develop data analytics platforms to trend and summarize GMP and Commercial process performance, enabling both process optimization as well as Continued Process Verification
Support scale-up activities and tech transfer of early phase clinical candidates to an external CMO
Facilitate cross-functional process risk analysis using appropriate tools such as FMEA
Requirements
PhD in Chemical/Biochemical Engineering
MS
BS
Nice to have: Bioconjugate or protein purification knowledge
Intern, Manufacturing Associate, Downstream and Central ServicesUltragenyx Pharmaceutical · Bedford, US
Senior Engineer, Conjugation DevelopmentVaxcyte · San Carlos, US