Sr. Scientist

3 years at USP industrial experience), or M.Sc. with, at least 10 years of relevant experience (including >2 years at USP industrial experience). Must have a proven track record and expertise in high throughput process characterization and optimization techniques and tools (i.e. DoE, statistical analysis, QbD). Must have a proven track record of developing, optimizing and scale up of Continuous Perfusion and Fed-batch systems. Must have a proven track record and expertise in upstream process scale-up and scale-down to support commercialization. Must be proficient in designing and operating high throughput experiments using Amber15/Amber250. Proven track record of driving innovation and delivering results in timely manner. Extensive knowledge of cell culture process development specifically for biopharmaceuticals Direct experience and training in cell culture process development with cell lines such as CHO and mAb production in a shake flask, SUB or SS bioreactors (up to 500L) in batch, fed-batch and perfusion modes. Additional Job Requirements: Able to communicate technical details of projects and project strategy to clients and Cytovance client team members. Able to work independently and exercise good judgment based on experimental data . Strong written and oral communication skills. Able to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Able to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Proficient in technical writing and verbal communication to present updates to clients, top management, public groups, and/or boards of directors. Able to define problems, collect data, establish facts, and draw valid conclusions. Able to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Good working knowledge of regulatory agencies and guidance documents governing GMP manufacturing such as ICH, FDA, and EMA is preferred. CDMO experience within bioprocess development is highly preferred. Authorized to work in the USA. Physical Demands: While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand and sit. The employee is occasionally required to walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Work Environment: While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals consistent with a lab environment. The noise level in the work environment is usually moderate.

Qualifications:

Essential Experience and Requirements For This Role:

Ph.D. in Bioprocess or Biochemical Engineering with at least 7 years of relevant experience (including >3 years at USP industrial experience), or M.Sc. with, at least 10 years of relevant experience (including >2 years at USP industrial experience).

Must have a proven track record and expertise in high throughput process characterization and optimization techniques and tools (i.e. DoE, statistical analysis, QbD).

Must have a proven track record of developing, optimizing and scale up of Continuous Perfusion and Fed-batch systems.

Must have a proven track record and expertise in upstream process scale-up and scale-down to support commercialization.

Must be proficient in designing and operating high throughput experiments using Amber15/Amber250.

Proven track record of driving innovation and delivering results in timely manner.

Extensive knowledge of cell culture process development specifically for biopharmaceuticals

Direct experience and training in cell culture process development with cell lines such as CHO and mAb production in a shake flask, SUB or SS bioreactors (up to 500L) in batch, fed-batch and perfusion modes.

Additional Job Requirements:

Able to communicate technical details of projects and project strategy to clients and Cytovance client team members.

Able to work independently and exercise good judgment based on experimental data .

Strong written and oral communication skills.

Able to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.

Able to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.

Proficient in technical writing and verbal communication to present updates to clients, top management, public groups, and/or boards of directors.

Able to define problems, collect data, establish facts, and draw valid conclusions.

Able to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Good working knowledge of regulatory agencies and guidance documents governing GMP manufacturing such as ICH, FDA, and EMA is preferred.

CDMO experience within bioprocess development is highly preferred.

Authorized to work in the USA.