Sr. Scientist Engineer

Job Description

General Summary:

The mammalian upstream process development (USP) team within the R&D organization is responsible for cell line development, cell culture technologies, and bioprocess development and optimization activities at Cytovance. The Mammalian USP activities include the development of cell culture platforms such as media and bioprocess technologies for batch, fed-batch, and perfusion systems from early phase development (i.e., shake flasks and small scale high throughput bench top bioreactors) to the pilot scale to support cGMP-Like tox material production.

The USP Sr. Scientist leads multiple client projects to meet timeline, budget and scope commitments and has good working knowledge of cell culture development pertaining to drug development. The Scientist has a proficient working knowledge of all relevant disciplines pertaining to the drug development process and knowledge of relevant business elements. She/He keeps an up-to-date awareness of advances in multiple technological and scientific areas and has strong academic and industrial network. He/She may supervise and mentor other colleagues by providing guidance, coaching, and career development support.

Essential Duties and Responsibilities:

Responsible for leading and overseeing multiple client projects in parallel.

Design, plan, and execute experimental protocols using shake-flasks, high throughput bioreactor systems (ambr15/ ambr250) and bench-top small scale bioreactors to optimize upstream cell culture process performance for manufacturing a variety of biologics such as mAb and therapeutic recombinant proteins.

Independently optimize and develop robust and scalable bioprocess platforms primarily fed-batch and perfusion systems.

Drive innovation by scouting, assessing, developing, and implementing new technology platforms such as but not limited to PAT, process control, culture media and feed media optimization, etc.

Support additional R&D Services teams (e.g., Cell line development, downstream development, microbial USP and Analytical Development) by generating, reviewing, and interpreting USP results.

Support Manufacturing groups by leveraging cell culture expertise to support investigations, troubleshooting complex technical challenges.

Specify, source, and assess new cell culture USP technologies

Perform data acquisition, reduction and evaluation

Specify and source new upstream equipment to expand the cell culture capabilities of the upstream development laboratory

Apply technical and scientific knowledge to the overall direction of projects.

Use a high level of scientific judgment to adapt and/or create standard methods and techniques by applying breadth of knowledge and prior work experience.

Identify and develop scientific strategies to support mid-term to long-term goals.

Represent technological areas and Cytovance business perspectives at client project team meetings

Exemplify sound supervisory and training skills and take personal responsibility for the development of direct reports.

Recommend and implement unique approaches to problem solving.

Demonstrate good strategic project prioritization skills working in a multi-project environment.

Critically evaluate information from a wide range of sources and make clear recommendations.

Represent Cytovance and Upstream cell culture technical area in client team meetings

Stay up to date on new technology trends, coach junior scientists through on the job training and through sharing novel bioprocess development and cell culture methodologies.

Work outside normal working hours may be required.

Serve as a point-of-contact and subject matter expert for cell culture processes and troubleshooting cell culture problems

Align client and business goals to enable both client and Cytovance success

Supervise and perform upstream cell culture development

Support the transfer of upstream cell culture process from R&D Services to the Cytovance MST group for transfer of process to manufacturing.

Draft and review Standard Operating Procedures (SOP’s)

Draft and review Upstream Protocols, Batch Records, Slide Deck Data Summaries and Reports

Train others on cell culture techniques

Mentor and educate others on cell culture theory and application

Stay current with all training requirements.

Follow procedures reliably and consistently.

Establish good working relationships with peers and other colleagues.

Display a positive attitude and good flexibility.

Proactively ensure good lab hygiene is being practiced.

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.

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.

Acknowledgment:

I have received, reviewed and fully understand the above job description. I further understand that I am responsible for the satisfactory execution of the essential duties described therein, under any and all conditions as described.

Full-time