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1+ months

Process Development Sr. Scientist

Kelly Services
Oklahoma City, OK 73165
**Kelly is actively recruiting for a Direct Hire Process Development Sr. Scientist in Greater Oklahoma City area, OK.**


The Process Development 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 Sr. Scientist has a good 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 contacts. He/She may supervise or mentor other colleagues providing guidance, coaching and career development support.


**Essential Duties and Responsibilities:**



+ Will be responsible for leading multiple client projects in parallel in cell culture.

+ Work with R&D Directors and senior leadership on developing cell culture processes for client projects along with innovative internal experiments

+ Perform process research and development on a variety of cell culture derived biopharmaceuticals including MAbs, Immunoglobulins, vaccines

+ Perform cell culture in shake flask, wave, and bioreactors (batch, fed-batch)

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

+ Represent Client and Upstream cell culture technical area in client team meetings

+ Align client and business goals to enable both client and Client success

+ Supervise and perform upstream cell culture development

+ Transfer upstream cell culture process from R&D Services to the Client MST group for transfer of process to manufacturing.

+ Draft and review Standard Operating Procedures (SOPs)

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


+ Support other Upstream Scientists or Analysts by assisting in USP troubleshooting measures and cross-review of results and notebooks

+ Support additional R&D Services teams (Cell line development, Purification development and Analytical Development) by generation, review, and/or interpretation of USP results

+ Support Manufacturing groups be leveraging cell culture expertise to support investigations and/or generation, review, and interpretation of cell culture results

+ Operate, maintain, and qualify (I/O/PQ) laboratory equipment and software as required

+ 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

+ Train others on cell culture techniques

+ Mentor and teach others on cell culture theory and application

+ Serve as a liaison with cell culture subcontractors

+ Supervision of direct reports will be required


+ 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.

+ Apply technical and scientific knowledge to the overall direction of projects. Enable Client to be using the most advance technology available. Acts as a scientific resource across disciplines.

+ Make decisions that consistently require developing new options to solve complex problems.

+ 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.

+ Work under minimal supervision. Exercise considerable latitude in determining objectives of assignments.

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

+ Represent technological areas and Clients business perspectives at client project team meetings

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


**Job Requirements:**


+ Ph.D., preferred in biochemistry or related science, with a combination of 4 years of laboratory experience that may be a combination of Post -Doctoral, Academic or Industrial settings

+ MS, in biochemistry or related science, with a minimum of 10 years directly related experience in protein purification

+ Has extensive knowledge of cell culture process development specifically for biopharmaceuticals

+ Has direct experience and training in cell culture process development with cell lines such as CHO, HEK293 in a shake flask and bioreactors in batch, fed-batch and perfusion mode.

+ Has broad knowledge of principles, concepts, and practices with a range of analytical techniques including ELISA, HPLC, enzymatic, and electrophoresis (SDS-PAGE, Western blots, IEF, & CE) procedures

+ Good working knowledge of scientific and technologic disciplines within pharmaceutical sciences

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

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

+ Recommends and implements unique approaches to problem solving

+ Demonstrates good strategic project prioritization skills working in a multi-project environment

+ Critically evaluates information from a wide range of sources and makes clear recommendations

+ Able to work in a semi-independent manner 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.

+ Able to write speeches and articles for publication that conform to prescribed style and format.

+ Able to effectively present information to 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.


**If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.**


**_\#TJP2022_SPEC_**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-04-06 Expires: 2022-06-06

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Process Development Sr. Scientist

Kelly Services
Oklahoma City, OK 73165

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