The pipeline product manufacturing associate will be responsible for supporting Poseida’s internal manufacturing operations by working as a cleanroom operator and verifier in the aseptic production of several biomolecules including but not limited to plasmid DNA, mRNA, guide RNA, proteins and small biomolecules.
These may include but are not limited to:
- Production of plasmid DNA at small to medium scale: The associate will perform bacterial transformation, strain selection, small to medium scale bacterial culture, harvest, DNA isolation.
- Production of mRNA at small to medium scale: The associate will generate DNA template, in vitro transcribe mRNA, purify and concentrate mRNA.
- Production of small biomolecules and proteins: Aseptically reconstitute premade vials of certain biomolecules or proteins to the requested specifications for downstream use.
- Perform certain in-process tests during the production campaigns to ensure that intermediate production products are of high quality
- Apply their molecular biology knowledge to troubleshoot problems and improve production capabilities.
- Maintain cleanroom standards, practices, and housekeeping according to standard operating procedures
- Read and follow Standard Operating Procedures (SOPs) and manufacturing work instructions. Fill out batch records, file deviation reports etc. during the manufacturing process
- Write or revise batch records, SOPs etc.
- Be involved in the design, installation, and validation of new equipment and additional clean rooms
- Coordinate equipment maintenance and instrument calibration
Requirements, Knowledge, Skills and Abilities
- Minimum of Bachelor’s degree in a chemical/biochemical engineering related discipline and at least 2 years of relevant work experience, ideally in a cleanroom environment manufacturing nucleic acids (an equivalent combination of education and experience may be considered)
The ideal candidate will possess:
- A good understanding of current Good Manufacturing and Documentation Practices
- A strong understanding of molecular biology principles especially as they apply to mRNA/DNA production
- Excellent aseptic technique
- Experience working with commercially available kits that are used to produce research grade DNA and mRNA (pilot or commercial-scale nucleic acid manufacturing experience is a bonus)
- Tissue culture experience (bonus)
- Chromatography experience (bonus)
- The ability to communicate clearly and precisely, both orally and in writing
- High attention to detail
- Proficiency with the MS-Office suite of productivity software and basic computer skills
- Ability to solve basic math problems such as those required in the execution of a molecular biology protocol
- Ability to work on multiple tasks simultaneously and meet project deadlines
- Experience working on cross-functional teams and a commitment to working in a fast-paced environment.
- Some weekend and after-hours work will be required
- Work that requires several hours of standing continuously
- Work may involve repetitive arm/wrist motions
Who We Are and What We Do
Poseida is a San Diego based biotechnology leader in the development of cell and gene therapies. We have built a wholly-owned pipeline of autologous and allogeneic chimeric antigen receptor T cell, or CAR-T, product candidates, initially focused on the treatment of hematological malignancies and solid tumors. Here at Poseida we are constantly innovating and growing as we advance our CAR-T therapies in the clinic and our gene therapies currently under development. The Poseida team is passionate about the impact we are making in developing treatments, or even cures, for patients with cancer or other genetic diseases.
The company’s CAR-T product candidates are manufactured with Poseida’s non-viral piggyBac® DNA Modification System, resulting in a high percentage of stem cell memory T cells (TSCM). Tscm cells are the only T cells that are self-renewing and long-lived, potentially resulting in product candidates that are more efficacious, less toxic and more durable. Poseida is currently developing the following CAR-T product candidates:
- P-BCMA-101 is an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma, currently enrolling patients for a Phase 2 registrational trial with initial dosing expected in the first half of 2019.
- P-PSMA-101 is an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer, with filing of an IND anticipated in the second half of 2019.
- P-BCMA-ALLO1 is an allogeneic, or universal donor, CAR-T product candidate, manufactured using Poseida’s proprietary Cas-CLOVER™ site specific gene editing system and is being developed as a treatment for relapsed/refractory multiple myeloma, with an IND filing anticipated by late 2019 or early 2020.
- P-MUC1C-101 is an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications, including ovarian, breast, lung, colorectal, pancreatic and renal cancers, with filing of an IND anticipated in 2020.
Poseida plans to broadly advance its current CAR-T programs and emerging pipeline programs, including gene therapies for orphan genetic diseases.
To apply send your resume and cover letter to firstname.lastname@example.org.