Cellics Therapeutics, Inc.
Scientist/Sr. Scientist, Downstream Process Development
Cellics Therapeutics, Inc., San Diego, California, United States, 92189
Scientist/Sr. Scientist, Downstream Process Development
Cellics Therapeutics is a pioneering and nimble biotech company using its innovative Cellular Nanoparticle (CNP) platform technology to develop nano-therapeutics and drive breakthrough drug delivery. The team is small and mighty. Each employee is empowered to shape our culture and our future success!
Cellics Therapeutics, Inc. provided pay range This range is provided by Cellics Therapeutics, Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $110,000.00/yr - $155,000.00/yr
Additional compensation types Annual Bonus and Stock options
Position Summary
Cellics Therapeutics is seeking a Downstream Scientist/Senior Scientist (level dependent on experience) to join the Process Development and Manufacturing team to lead CNP production in support of our drug development and regulatory filings. The candidate will provide hands‑on support on process improvement, tech transfer, and GMP manufacturing.
Essential Duties and Responsibilities
Lead the design and execution of experiments to develop a robust and efficient process to produce drug substances and drug products that meet the specifications
Conduct experiments and analyze results to define and optimize process parameters
Document the experiments and results in lab notebook and write technical reports to support the process and product development
Lead all cGMP manufacturing activities to make materials for stability evaluation and supply drug products for preclinical and clinical studies
Write and review manufacturing batch records
Prepare CMC documentation for regulatory and IND filing
Work closely within the process development team as well as with other functional groups to ensure that key product requirements are identified and delivered
Perform all job‑related duties in a safe, organized, and efficient manner to assure project requirement and deadline
Qualifications
Ph.D. or M.S. degree in Biotechnology, Biomedical Engineering, Chemical Engineering, or related fields
1+ year of experience for Ph.D. or 3+ years of experience for M.S. in downstream process development or manufacturing role in Biotech or Pharmaceutical industry
Hands‑on experience on downstream process unit operations, such as tangential flow filtration (TFF), normal flow filtration, depth filtration, microfluidization, centrifugation, and chromatography
cGMP manufacturing experience is a plus
Experience in biologics regulatory submissions (IND, BLA) desirable
In‑depth knowledge in nanoparticle production and characterization highly desirable
Experience with analytical methods such as HPLC and bioassays is a plus
Self‑motivated and able to thrive in a dynamic environment
Detail‑oriented with sound data analysis and process trouble‑shooting skills
Excellent problem‑solving skills and verbal and written communication skills
Open‑mindedness to learn and share professional knowledge and experience
May be required to lift up to 25 pounds
Please, no search firms.
Benefits
Medical insurance
Vision insurance
401(k)
Disability insurance
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Research, Analyst, and Information Technology
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Cellics Therapeutics, Inc. provided pay range This range is provided by Cellics Therapeutics, Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $110,000.00/yr - $155,000.00/yr
Additional compensation types Annual Bonus and Stock options
Position Summary
Cellics Therapeutics is seeking a Downstream Scientist/Senior Scientist (level dependent on experience) to join the Process Development and Manufacturing team to lead CNP production in support of our drug development and regulatory filings. The candidate will provide hands‑on support on process improvement, tech transfer, and GMP manufacturing.
Essential Duties and Responsibilities
Lead the design and execution of experiments to develop a robust and efficient process to produce drug substances and drug products that meet the specifications
Conduct experiments and analyze results to define and optimize process parameters
Document the experiments and results in lab notebook and write technical reports to support the process and product development
Lead all cGMP manufacturing activities to make materials for stability evaluation and supply drug products for preclinical and clinical studies
Write and review manufacturing batch records
Prepare CMC documentation for regulatory and IND filing
Work closely within the process development team as well as with other functional groups to ensure that key product requirements are identified and delivered
Perform all job‑related duties in a safe, organized, and efficient manner to assure project requirement and deadline
Qualifications
Ph.D. or M.S. degree in Biotechnology, Biomedical Engineering, Chemical Engineering, or related fields
1+ year of experience for Ph.D. or 3+ years of experience for M.S. in downstream process development or manufacturing role in Biotech or Pharmaceutical industry
Hands‑on experience on downstream process unit operations, such as tangential flow filtration (TFF), normal flow filtration, depth filtration, microfluidization, centrifugation, and chromatography
cGMP manufacturing experience is a plus
Experience in biologics regulatory submissions (IND, BLA) desirable
In‑depth knowledge in nanoparticle production and characterization highly desirable
Experience with analytical methods such as HPLC and bioassays is a plus
Self‑motivated and able to thrive in a dynamic environment
Detail‑oriented with sound data analysis and process trouble‑shooting skills
Excellent problem‑solving skills and verbal and written communication skills
Open‑mindedness to learn and share professional knowledge and experience
May be required to lift up to 25 pounds
Please, no search firms.
Benefits
Medical insurance
Vision insurance
401(k)
Disability insurance
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Research, Analyst, and Information Technology
#J-18808-Ljbffr