Scientist (I/II/III) - Process Engineering/Upstream/Immunology at CyberCoders
Montgomery Village, MD 20886
About the Job
If you are a Scientist (I/II/III) - Process Engineering/Upstream/Immunology with experience, please read on!
Located in beautiful Gaithersburg, MD, we are a biotech company focused on immuno-oncology cell therapies.
**Relocation available!!
Located in beautiful Gaithersburg, MD, we are a biotech company focused on immuno-oncology cell therapies.
**Relocation available!!
Top Reasons to Work with Us
- Great work/life balance
- Growth!
- Competitive Pay!
- Growth!
- Competitive Pay!
What You Will Be Doing
We are seeking candidates with extensive experience in developing, optimizing, and scaling up upstream processes from bench to pilot-scale with preferably some experience working in cGxP regulated environment and a basic understanding of ICH and FDA regulatory/quality guidelines. Qualified candidates must demonstrate a broad and current technical/scientific knowledge of process development, optimization, and scale-up methodologies to develop robust and scalable production processes.
Upstream candidates will have hands-on experience working with different mammalian expression systems, shaker and spinner flask cultures, conventional and single-use bioreactor systems, and have thorough understanding of cell culture laboratory techniques and practices. Candidates must have experience conducting media screening and feed strategy optimization studies as well as studies to identify and determine appropriate ranges of (critical) process parameters to optimize cell growth and productivity.
Candidates for the Scientist position will demonstrate additional knowledge of, and preferably have experience with, statistical tools, DOE (and software) and QbD principles as well as SDM development/qualification, process range finding, and robustness/characterization studies.
Candidates must have excellent technical writing skills and experience in preparing SOPs, protocols, technical reports, and/or batch records. Additional IND CMC and regulatory filing experience is a plus. Candidates must have good communication and interpersonal skills. Candidates must have a demonstrated ability to think critically, analyze and interpret data independently, design and execute appropriately controlled experiments, and maintain up-to-date laboratory notebooks.
Upstream candidates will have hands-on experience working with different mammalian expression systems, shaker and spinner flask cultures, conventional and single-use bioreactor systems, and have thorough understanding of cell culture laboratory techniques and practices. Candidates must have experience conducting media screening and feed strategy optimization studies as well as studies to identify and determine appropriate ranges of (critical) process parameters to optimize cell growth and productivity.
Candidates for the Scientist position will demonstrate additional knowledge of, and preferably have experience with, statistical tools, DOE (and software) and QbD principles as well as SDM development/qualification, process range finding, and robustness/characterization studies.
Candidates must have excellent technical writing skills and experience in preparing SOPs, protocols, technical reports, and/or batch records. Additional IND CMC and regulatory filing experience is a plus. Candidates must have good communication and interpersonal skills. Candidates must have a demonstrated ability to think critically, analyze and interpret data independently, design and execute appropriately controlled experiments, and maintain up-to-date laboratory notebooks.
What You Need for this Position
- B.A/B.S., M.S. or PhD. in life sciences or biochemical engineering with a minimum of 5-10 years biotech industry experience in process development, optimization, and scale-up.
- Basic knowledge of GxP policies and procedures and regulatory/quality requirements in the biotech industry
- Additional experience in IND/regulatory filings, tech transfer and/or pilot- or large-scale cGMP manufacturing a plus.
- Senior level candidates should have knowledge of statistical tools and DoE (incl software), QbD principles, and with scale-down model development/qualification, process range, linkage, and/or process characterization studies.
- Proficient with the use of MS Office software (Word, Excel, Power Point) and process equipment application software.
- Excellent problem solving, organizational, and time management skills.
- Must demonstrate initiative and be self-motivated.
- Must have excellent communication and writing skills.
- Positive attitude and interpersonal skills and the ability to work in team-oriented environment are essential.
- Ability to plan, design, execute, and record experiments using good scientific principles and with keen attention to detail.
- Candidates must have a demonstrated ability to think critically and analyze and interpret data independently.
- Basic knowledge of GxP policies and procedures and regulatory/quality requirements in the biotech industry
- Additional experience in IND/regulatory filings, tech transfer and/or pilot- or large-scale cGMP manufacturing a plus.
- Senior level candidates should have knowledge of statistical tools and DoE (incl software), QbD principles, and with scale-down model development/qualification, process range, linkage, and/or process characterization studies.
- Proficient with the use of MS Office software (Word, Excel, Power Point) and process equipment application software.
- Excellent problem solving, organizational, and time management skills.
- Must demonstrate initiative and be self-motivated.
- Must have excellent communication and writing skills.
- Positive attitude and interpersonal skills and the ability to work in team-oriented environment are essential.
- Ability to plan, design, execute, and record experiments using good scientific principles and with keen attention to detail.
- Candidates must have a demonstrated ability to think critically and analyze and interpret data independently.
What's In It for You
- 401(k)
- 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible schedule
- Flexible spending account
- Health insurance
- Paid time off
- Parental leave
- Referral program
- Tuition reimbursement
- Vision insurance
- 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible schedule
- Flexible spending account
- Health insurance
- Paid time off
- Parental leave
- Referral program
- Tuition reimbursement
- Vision insurance
So, if you are a Scientist (I/II/III) - Process Engineering/Upstream/Immunology with experience, please apply today!
Estimated Salary
78,112.00 - 104,781.00 /year
Biology Research Scientist
What is this?
Biology Research Scientist