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Aerotek Senior Scientist- Downstream in Milford, Massachusetts

Top Skills Details:

  1. Purification Process Development

  2. AKTA chromatography

  3. GMP/GLP compliance

  4. Tech Transfer of methods

  5. Filtration (UF, DF, TFF)

Nice to Have: CDMO or CMO experience

Description:

Summary:

This Sr. Scientist position in the Downstream Process Development group. The person in this role is a functional project (s) lead, who independently designs, executes, and support biologics downstream purification process including technology transfer activities both from the client(s) and internally to GMP manufacturing facility.(The most critical one is the first point; it is actually a very specific skill set for someone to be able to develop a process and the understanding of process characterization)

• Development of scale-able and robust downstream processes including process characterization, and/or technology transfer leading to clinical and commercial GMP manufacturing for multiple client projects meeting the project deliverables.

• Design experiments related to development, optimization, scale-up of all steps in a monoclonal antibody and bispecific antibody purification process and viral clearance study, execute studies together with junior members

• Apply DOE and other advanced statistical techniques to design experiments related to process characterization

• Author high-quality documents, including technical reports, SOPs, and experimental protocols

• Development of scale-able and robust downstream processes including process characterization, and/or technology transfer leading to clinical and commercial GMP manufacturing for multiple client projects meeting the project deliverables.

• Design experiments related to development, optimization, scale-up of all steps in a monoclonal antibody and bispecific antibody purification process and viral clearance study, execute studies together with junior members

• Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding

• Apply DOE and other advanced statistical techniques to design experiments related to process characterization

• Author high-quality documents, including technical reports, SOPs, and experimental protocols

02/2020

• Serve as PD representative and participate in cross functional meetings

• Contribute to scale up activities and draft tech transfer related documents (e.g. process description, process flow diagram)

• Conduct facility fit exercise

• Review batch records and provide comments

• Support MFG floor activities

• Provide technical support (e.g. process/operational gap identification and troubleshooting) to MFG group

• Training and lead of associate scientists

• Present data at client project teams and written reports

• Contribute to the overall operations of process sciences lab and infrastructure improvements.

• Provide technical and strategic planning support to business development activities with respect to new client projects and new business initiatives.

Additional Skills & Qualifications:

• Ph.D. in life sciences or engineering with 5 to 8 years of relevant experience or equivalent BS/ MS experience.

• Solid theoretical knowledge and hands-on experience in protein purification and analytical characterization.

• Hands-on experience with purification unit operations including filtration, different mode chromatography, UF/DF, AKTA, UNICORN, centrifugation

• The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills.

• Advanced ability with Microsoft Office (Word, Excel, and PowerPoint)

• Demonstrates ability to work both independently and as a member of local / global teams.

• Excellent customer service skills and ability to meet client project deadlines.

• Flexibility of hours to support cell culture process over weekends and holidays. Weekend and holiday hours are compensated per HR company

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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