Role : Sr Research Associate with experience in protein purification process development and process characterization to support our biologics development group (early and late-stage development of our protein molecules). Focus: Downstream Process Development.

Working Hours : Mon-Fri business hours (i.e., 8am-5pm, 8:30am-5pm)

Duration : 1 year

Top 3 Must Have:

• Skills in data analysis and interpreting experiment outcomes including the ability to evaluate data quality and recognize anomalous results
• Demonstrate strong verbal communication and interpersonal skills including the ability to explain processes used to achieve results of assigned tasks.
• Working understanding of downstream process development including centrifugation, normal and tangential flow filtration, chromatography operations, and virus clearance. The ability to demonstrate hands on experience in several of these areas is expected.

Ideal Requirements (in addition to Must Have's):

• Experience in biologics purification, with an emphasis on conjugation, tangential flow filtration (UF/DF), and filtration.
• Knowledge of cGMPs, technology transfer, and scaling up bioprocesses
• Experience with multiple modalities - specifically mAbs and antibody drug conjugates

Essential Duties and Job Functions:

• Plan and execute assigned experiments on-site that support Process Development activities and project goals.
• Select appropriate methods and techniques for performing experiments.
• Recommend alternatives, research new methods and techniques and proactively seek out senior personnel to discuss potential solutions to problems.
• Participate in group meetings and present results, data interpretation and conclusions.
• Work with team oriented, collaborative and problem-solving mindset.
• Always work with safety in mind. Able to work with highly potent compounds upon training.

Knowledge, Experience and Skills:

• Experience in analytical operations: SEC/HPLC, CE (R/NR), HCP testing is beneficial, but not required.
• Must be able to work effectively in cross-functional teams.
• Must demonstrate excellent technical writing skills.
• Experience with multiple modalities (mAbs, bispecific, fusion and antibody drug conjugates, virus particles) produced in microbial and mammalian expression systems is a plus.
• Ability to work effectively within the purification team to help design and execute experiments supporting process definition, optimization, and characterization with an increasing level of independence.
• Ability to collaborate with Technical Operations during technology transfer from process development to GMP manufacturing, including serving as a process development representative during purification operations, providing technical troubleshooting and identifying opportunities for future process and equipment improvements. The candidate will also contribute to the preparation of regulatory filings and process validation and characterization reports.
• Ability to effectively communicate ideas, project goals and results and should have the ability to proactively identify issues and suggest solutions in a collaborative, multidisciplinary environment. This is a highly collaborative environment where willingness and ability to communicate and work effectively with individuals across various teams is essential.
• Self-motivated, organized, and enjoy scientific investigation and thinking. The candidate will monitor and contribute to external literature and scientific conferences.

Education/Qualifications - preferred degree in Chemical/Biochemical Engineering, Biochemistry, Chemistry or a related scientific discipline.

BS degree in a relevant scientific discipline and 2+ years of relevant experience; OR

MS degree in a relevant scientific discipline and 1-2+ years of relevant experience