NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Protein Development and Manufacturing
Reports To: VP, PD/MFG
Status: Full Time/Exempt

Position Summary:

We are seeking Senior Scientist candidates with extensive biotech industry experience in developing, optimizing, and scaling up downstream manufacturing processes from bench to pilot-scale production (preferably cGMP manufacturing).

Qualified candidates will demonstrate a broad and current technical/scientific knowledge of downstream process development, optimization, and scale-up methodologies to develop robust and scalable production processes. Suitable candidates will have hands-on experience in all common chromatography separation (affinity, ion exchange, mixed mode, hydrophobic interaction) and filtration methods (depth, traditional/single-pass TFF, virus, sterile) as well as virus inactivation (detergent, low pH). Candidates with Bio-Rad NGC and/or GE AKTA experience and with basic protein analytical skills (HPLC and capillary electrophoresis or SDS-PAGE) are preferred.

In addition to the above, candidates for the Senior Scientist position will demonstrate additional working knowledge in one or more of the following: DOE and statistical tools for design and analysis of experiments, QbD principles, scale-down model development and qualification, as well as process linkage and characterization studies. Senior scientist candidates should also have a good working understanding of current FDA and ICH guidelines and preferably have some IND CMC and regulatory filing experience.

Candidates must have excellent communication and writing skills, with extensive experience preparing technical documents (e.g. SOPs, protocols, technical reports, and/or batch records). Candidates must have a demonstrated ability to work independently, design and execute appropriately controlled experiments, analyze and interpret data critically, and maintain up-to-date laboratory notebooks.

Qualifications:

• B.A/B.S., M.S. or PhD. in life sciences or biochemical engineering with a minimum of 10 years of biotech industry experience in downstream process development, optimization, and scale-up.
• Basic knowledge of GxP guidelines for the biotech industry
• Experience with BioRad NGC and/or GE AKTA systems and protein analytical methods preferred.
• Extensive working knowledge of all common chromatography and filtration methodologies.
• Tech transfer and/or pilot- or large-scale cGMP manufacturing experience a plus.
• Proficient with the use of MS Office software (Word, Excel, Power Point).
• 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
• Candidates must have a demonstrated ability to think critically and analyze and interpret data independently.
• Can coordinate and prioritize parallel tasks.
• Must be flexible and able to adapt to changing demands.
• Senior Scientist position will demonstrate working knowledge in or more of the following: statistical tools and DOE, QbD principles, process characterization studies, FDA and ICH guidelines, IND and/or regulatory (CMC) filing experience.

Responsibilities:

• Plan, design, execute, and record experiments, and independently analyze results using good scientific principles and with keen attention to detail and quality. Maintain up-to-date GLP compliant lab notebook.
• Develop, optimize, and scale up robust and efficient purification process for pilot production and subsequent cGMP manufacturing of Phase I candidates.
• Screen different resins and filters systemically and then conduct follow-on optimization, process range finding, and robustness studies to optimize protein yield and purity.
• Perform experiments using Bio-Rad NGC and GE AKTA chromatography systems, conventional and single-pass TFF systems, and industry standard filtration (harvest, sterile, viral) methods at bench and pilot-scale.
• Participate in transfer of downstream processes to in-house pilot GMP production suite (or CMO if required) and conduct engineering and cGMP pilot manufacturing runs.
• Perform standard in-process analytical techniques including HPLC, SDS-PAGE/CE, and protein assays.
• Write development reports (progress, summary, tech transfer), protocols, and SOPs.
• Support drafting and/or revisions of production batch records for cGMP manufacturing as well as close-out of executed batch records with QA.

Qualified, interested candidates should send a resume to: careers@neximmune.com

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Preclin. Immunotherapy (PCI)
Reports To: VP
Status: Full Time/Exempt

Position Summary:

The Research Associate/ Senior Research Associate in Cell Biology/Immunotherapy will act as a scientific contributor for the Preclinical Immunotherapy Department developing and optimizing a new clinical approach to adoptive T cell therapy, based upon NexImmune’s proprietary artificial Antigen Presenting Cell (aAPC) technologies. The candidate will assist in the generation and phenotypical and functional characterization of antigen-specific T cells. Laboratory skills, notebook recording/maintenance, and writing of reports in acceptable scientific format(s) are important.

Essential Duties and Responsibilities:

• Assist in the culture of mammalian cell lines
• Isolation and expansion of Antigen-specific T cells.
• FACS analysis
• Perform ELISA and protein assays
• Order supplies and reagents, maintain inventory records
• Write reports, protocols and SOPs

Education and Experience:

• BA or MS in Life science (Immunology, Biology, Biochemistry, Biochemistry, or related field) with 1-3 years of hands-on experience in industry
• Experience in Immunology and T cell biology
• Experience working in mammalian cell culture, sterile techniques
• Experience with FACS and panel design
• Experience ELISA and other plate reader assays
• Experience with handling clinical samples
• Demonstrated proficiency in FlowJo, GraphPad Prism, and Microsoft Office, including Word, Excel, PowerPoint

Desired Key Competencies:

• Excellent communication skills
• Self-motivated and independently minded
• Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function
• Self-organizer, meticulous hands-on habits, keen attention to detail
• Strong quantitative and analytical skills
• Responsive, can-do attitude
• Can coordinate parallel tasks across multiple projects, demonstrating prioritization
• Ability to quickly adapt to a rapidly changing environment and demands
• Ability to interpret and effectively execute upon a variety of instructions provided in written, oral, diagram or schedule formats

Qualified, interested candidates should send a resume to: careers@neximmune.com

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Protein Development and Manufacturing
Reports To: VP, PD/MFG
Status: Full Time/Exempt

Position Summary:

We are seeking Scientist candidates with extensive biotech industry experience in developing, optimizing, and scaling up downstream manufacturing processes from bench to pilot-scale production (preferably cGMP manufacturing).

Qualified candidates will demonstrate a broad and current technical/scientific knowledge of downstream process development, optimization, and scale-up methodologies to develop robust and scalable production processes. Suitable candidates will have hands-on experience in all common chromatography separation (affinity, ion exchange, mixed mode, hydrophobic interaction) and filtration methods (depth, traditional/single-pass TFF, virus, sterile) as well as virus inactivation (detergent, low pH). Candidates with Bio-Rad NGC and/or GE AKTA experience and with basic protein analytical skills (HPLC and capillary electrophoresis or SDS-PAGE) are preferred.

Candidates must have excellent communication and writing skills, with extensive experience preparing technical documents (e.g. SOPs, protocols, technical reports, and/or batch records). Candidates must have a demonstrated ability to work independently, design and execute appropriately controlled experiments, analyze and interpret data critically, and maintain up-to-date laboratory notebooks.

Qualifications:

• B.A/B.S., M.S. or PhD. in life sciences or biochemical engineering with a minimum of 5 years of biotech industry experience in downstream process development, optimization, and scale-up.
• Basic knowledge of GxP guidelines for the biotech industry
• Experience with Biorad NGC and/or GE AKTA systems and protein analytical methods preferred.
• Extensive working knowledge of all common chromatography and filtration methodologies.
• Tech transfer and/or pilot- or large-scale cGMP manufacturing experience a plus.
• Proficient with the use of MS Office software (Word, Excel, Power Point).
• 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
• Candidates must have a demonstrated ability to think critically and analyze and interpret data independently.
• Can coordinate and prioritize parallel tasks.
• Must be flexible and able to adapt to changing demands.

Responsibilities:

• Plan, design, execute, and record experiments, and independently analyze results using good scientific principles and with keen attention to detail and quality. Maintain up-to-date GLP compliant lab notebook.
• Develop, optimize, and scale up robust and efficient purification process for pilot production and subsequent cGMP manufacturing of Phase I candidates.
• Screen different resins and filters systemically and then conduct follow-on optimization, process range finding, and robustness studies to optimize protein yield and purity.
• Perform experiments using Bio-Rad NGC and GE AKTA chromatography systems, conventional and single-pass TFF systems, and industry standard filtration (harvest, sterile, viral) methods at bench and pilot-scale.
• Participate in transfer of downstream processes to in-house pilot GMP production suite (or CMO if required) and conduct engineering and cGMP pilot manufacturing runs.
• Perform standard in-process analytical techniques including HPLC, SDS-PAGE/CE, and protein assays.
• Write development reports (progress, summary, tech transfer), protocols, and SOPs.
• Support drafting and/or revisions of production batch records for cGMP manufacturing as well as close-out of executed batch records with QA.

Qualified, interested candidates should send a resume to: careers@neximmune.com

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Preclin. Immunotherapy (PCI)
Reports To: VP
Status: Full Time/Exempt

Position Summary:

The Scientist/Sr. Scientist in Cell Biology/Immunotherapy will act as a scientific contributor for the Preclinical Immunotherapy Department developing and optimizing a new clinical approach to adoptive T cell therapy, based upon NexImmune’s proprietary artificial Antigen Presenting Cell (aAPC) technologies. The candidate will assist in the generation and phenotypical and functional characterization of antigen-specific T cells. Laboratory skills, notebook recording/maintenance, and writing of reports in acceptable scientific format(s) are important.

Essential Duties and Responsibilities:

• T cell cloning
• Assay development and validation
• Isolation and expansion of Antigen-specific T cells
• FACS analysis and sorting
• Perform Cytokine and killing assays
• Perform ELISA and protein assays
• Order supplies and reagents, maintain inventory records
• Write reports, protocols and SOPs

Education and Experience:

• M.S. or Ph.D. in Life science (Immunology, Biology, Biochemistry, Biochemistry or related field)
• Experience in Immunology and T cell biology
• Experience working in mammalian cell culture, sterile techniques
• Experience with FACS
• Experience ELISA and other plate reader assays
• Experience performing and analyzing RT-PCR experiments
• Experience with HPLC, FPLC
• Experience with animal (mouse) models
• Demonstrated proficiency in Microsoft Office, including Word, Excel, and PowerPoint

Desired Key Competencies:

• Excellent communication skills
• Self-motivated and independently minded
• Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function
• Self-organizer, meticulous hands-on habits, keen attention to detail
• Strong quantitative and analytical skills
• Responsive, can-do attitude
• Can coordinate parallel tasks across multiple projects, demonstrating prioritization
• Ability to quickly adapt to a rapidly changing environment and demands
• Ability to interpret and effectively execute upon a variety of instructions provided in written, oral, diagram or schedule formats

Qualified, interested candidates should send a resume to: careers@neximmune.com

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Protein Development and Manufacturing
Reports To: VP, PD/MFG
Status: Full Time/Exempt

Position Summary:

We are seeking Scientist candidates with extensive biotech industry experience in developing, optimizing, and scaling up cell culture manufacturing processes from bench to pilot-scale production (preferably cGMP manufacturing).

Qualified candidates will demonstrate a broad and current technical/scientific knowledge of cell culture process development, optimization, and scale-up methodologies to develop robust, scalable, high-titer cell culture processes. Suitable candidates will have hands-on experience working with different mammalian expression systems, shaker and spinner flask cultures, single-use bioreactor systems, and have a thorough understanding of cell culture laboratory techniques and practices. Suitable candidates should have experience conducting cell line stability studies and establishing suitable process scale-down models. Candidates will need to demonstrate extensive experience conducting media screening, feed strategy, and bioreactor process parameter optimization studies to optimize cell growth and productivity.

Candidates must have excellent communication and writing skills, with extensive experience preparing technical documents (e.g. SOPs, protocols, technical reports, and/or batch records). Candidates must have a demonstrated ability to work independently, design and execute appropriately controlled experiments, analyze and interpret data critically, and maintain up-to-date laboratory notebooks.

Qualifications:

• B.A/B.S., M.S. or PhD. in life sciences or biochemical engineering with a minimum of 5 years of biotech industry experience in cell culture process development, optimization, and scale-up.
• Basic knowledge of GxP guidelines for the biotech industry
• Robust understanding of cellular biochemistry and metabolic pathways.
• Hands-on experience with spinner and shaker culture, and mini/bench to pilot scale bioreactor systems.
• Tech transfer and/or pilot- or large-scale cGMP manufacturing experience a plus.
• Proficient with the use of MS Office software (Word, Excel, Power Point).
• 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
• Candidates must have a demonstrated ability to think critically and analyze and interpret data independently.
• Can coordinate and prioritize parallel tasks.
• Must be flexible and able to adapt to changing demands.

Responsibilities:

• Plan, design, execute, and record experiments, and independently analyze results using good scientific principles and with keen attention to detail and quality. Maintain an up-to-date GLP compliant lab notebook.
• Develop, optimize, and scale up robust and high-yield cell culture fed-batch processes for pilot production and subsequent cGMP manufacturing of Phase I candidates.
• Characterize cell lines and evaluate cell line stability and suitability for pilot/GMP manufacture.
• Use DOE or other scientific methods to determine optimal growth parameters, media formulations, and feed strategies in small-scale shakers and mini-bioreactors.
• Participate in transfer of cell culture processes to in-house pilot GMP production suite (or CMO if required) and conduct engineering and cGMP pilot manufacturing runs.
• Write development reports (progress, summary, tech transfer), protocols, and SOPs.
• Support drafting and/or revisions of production batch records for cGMP manufacturing as well as close-out of executed batch records with QA.

Qualified, interested candidates should send a resume to: careers@neximmune.com

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Protein Development and Manufacturing
Reports To: VP, PD/MFG
Status: Full Time/Exempt

Position Summary:

We are seeking Senior Scientist candidates with extensive biotech industry experience in developing, optimizing, and scaling up cell culture manufacturing processes from bench to pilot-scale production (preferably cGMP manufacturing).

Qualified candidates will demonstrate a broad and current technical/scientific knowledge of cell culture process development, optimization, and scale-up methodologies to develop robust, scalable, high-titer cell culture processes. Suitable candidates will have hands-on experience working with different mammalian expression systems, shaker and spinner flask cultures, single-use bioreactor systems, and have a thorough understanding of cell culture laboratory techniques and practices. Suitable candidates should have experience conducting cell line stability studies and establishing suitable process scale-down models. Candidates will need to demonstrate extensive experience conducting media screening, feed strategy, and bioreactor process parameter optimization studies to optimize cell growth and productivity.

In addition to the above, candidates for the Senior Scientist position will demonstrate additional working knowledge in or more of the following: statistical tools and DOE, QbD principles, scale-down model development and qualification, and process characterization studies. Senior scientist candidates should also have a good working understanding of current FDA and ICH guidelines and preferably have some IND CMC and regulatory filing experience.

Candidates must have excellent communication and writing skills, with extensive experience preparing technical documents (e.g. SOPs, protocols, technical reports, and/or batch records). Candidates must have a demonstrated ability to work independently, design and execute appropriately controlled experiments, analyze and interpret data critically, and maintain up-to-date laboratory notebooks.

Qualifications:

• B.A/B.S., M.S. or PhD. in life sciences or biochemical engineering with a minimum of 10 years of biotech industry experience in cell culture process development, optimization, and scale-up.
• Basic knowledge of GxP guidelines for the biotech industry
• Robust understanding of cellular biochemistry and metabolic pathways.
• Hands-on experience with spinner and shaker culture, and mini/bench to pilot scale bioreactor systems.
• Tech transfer and/or pilot- or large-scale cGMP manufacturing experience a plus.
• Proficient with the use of MS Office software (Word, Excel, Power Point).
• 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
• Candidates must have a demonstrated ability to think critically and analyze and interpret data independently.
• Can coordinate and prioritize parallel tasks.
• Must be flexible and able to adapt to changing demands.
• Senior Scientist position will demonstrate additional working knowledge in or more of the following: statistical tools and DOE, QbD principles, process characterization studies, FDA and ICH guidelines, IND and/or regulatory (CMC) filing experience.

Responsibilities:

• Plan, design, execute, and record experiments, and independently analyze results using good scientific principles and with keen attention to detail and quality. Maintain an up-to-date GLP compliant lab notebook.
• Develop, optimize, and scale up robust and high-yield cell culture fed-batch processes for pilot production and subsequent cGMP manufacturing of Phase I candidates.
• Characterize cell lines and evaluate cell line stability and suitability for pilot/GMP manufacture.
• Use DOE or other scientific methods to determine optimal growth parameters, media formulations, and feed strategies in small-scale shakers and mini-bioreactors.
• Participate in transfer of cell culture processes to in-house pilot GMP production suite (or CMO if required) and conduct engineering and cGMP pilot manufacturing runs.
• Write development reports (progress, summary, tech transfer), protocols, and SOPs.
• Support drafting and/or revisions of production batch records for cGMP manufacturing as well as close-out of executed batch records with QA.

Qualified, interested candidates should send a resume to: careers@neximmune.com