Senior Associate Scientist, Downstream Process Development Position Available In Middlesex, New Jersey

Senior Associate Scientist, Downstream Process Development#25-62442
Cranbury, NJ
All On-site Job Description Job Summary Designs, executes and authors downstream purification development, tech transfer, and optimization studies. Conduct pilot scale material generation runs. Partners with other internal PD teams during process tech transfer, and supports GMP manufacturing and related investigation studies. Participates in client calls and face to face meetings with minimum supervision. Responsibilities Works independently on bench scale purification process development, optimization and process transfer studies. Designs and executes pilot – scale experiments to support non-GMP material generation.
Manages project workflow to ensure on time delivery: from initial planning, experiment execution, to data evaluation.
Performs independent data analysis and interpretation and develops strategies for optimization and troubleshooting.
Authors study protocols and reports, and ensures all data is reported clearly and accurately; Serves as trainer for inter and intradepartmental staff as needed.
Assists with tech transfer to GMP manufacturing and supports deviations and investigations.
Serves as downstream purification Smes to participates in client calls and face to face meetings. Provides project plans and updates to clients.
Authors downstream lab equipment SOPs; maintains equipment functionality and coordinates repairs and preventative maintenance
May be required to assist in other departments or assigned duties.
Contributes to the overall operations and to the achievement of departmental goal. Qualifications Bachalor in Life Sciences or related field, or experience in a biopharmaceutical or biological contract testing/manufacturing organization.
Hands on experience in downstream purification process development and lab scale experimental execution, including chromatography, UFDF, TFF, viral inactivation and filtration, etc.
Experience with pilot scale operation is a plus.
Strong oral and written communication skills are required
Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
Experience in a cGMP environment is highly desirable
Ability to take on multiple tasks simultaneously
Proficient in Microsoft (Excel, Word, Outlook)

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”