Scientist I

Title:- - Scientist I

Location: Waltham, MA

Duration: Contract until April 2027

Description:

We are looking for a candidate with experience in biologics or gene therapy purification development and bioprocess analytics.

Key Responsibilities:

• Lead and conduct viral/non-viral vector purification process development and process analytics

• Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology

• Develop, conduct, maintain analytical assays such as ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS etc. for in-process sample testing to support process development

• Provide scientific and technical expertise for in-process sample testing activities, including product quality and process impurity methodologies

• Perform troubleshooting experiments and communicate findings with appropriate working groups

• Maintain industry knowledge and keep abreast of new and relevant technologies

• Perform data analysis, contribute to technical reports, external publications, patent applications and internal/external presentations

• Lead scale-up activities to implement a manufacturing process based on DSP development knowledge

• Communicate effectively with internal and external teams, e.g. CDMOs for tech transfer activities

• Mentor and support junior staff and build a culture of support and collaboration

Basic Qualifications

• PhD in Biotechnology, Biochemistry, Chemical Engineering or related discipline or master's degree with a minimum of 4 years of relevant experience or a bachelor's degree with a minimum of 6 years of relevant experience

• Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS

• Significant experience, knowledge and understanding of purification technologies and operations such as:

o Filtration unit operations at various scales, including depth filtration, tangential flow filtration, etc.

o Protein purification chromatography

o Virus clearance and inactivation

• Familiarity with advanced purification technologies and process analytical technologies

• Familiarity with analytical method transfer, analytical method bridging across organizations

• Experience with process technology transfers and performing gap analyses and risk assessments

• Understanding of critical quality attributes and the principles of Quality by Design and ability to apply DOE to downstream development

• Expertise in technical report writing

Preferred Qualifications

• Experience in AAV and/or non-viral purification development

• Experience in writing CMC components of regulatory dossiers

• Knowledge of product comparability, target product profile and quality risk assessment activities

• Viral clearance study design and execution

• Late-stage purification experience such as design space mapping and process robustness studies

• Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs)

• Ability to work under minimal supervision and function within a collaborative, team-oriented environment

• Excellent organization and communication skills

• Innovative, critical and creative thinker, unafraid of proposing aggressive solutions to complex problems

• Experience with biophysical characterization

• Experience in continuous manufacturing and process analytical technology

• Experience in mentoring junior staff

• Ability to build and nurture cross-functional relationships

• Ability to communicate and represent group in diverse, multi-functional meetings

Thanks

MINAKSHI SANGWAN

Recruiting Lead - US Recruitment

O 732-339-3518

E Minakshi.sangwan@aequor.com

W http://www.aequor.com/