Research Associate II

Position Title: Research Associate II

Work Location: Waltham, MA 02451

Assignment Duration: 12 Months

Work Arrangement: Onsite (Lab-based)

Notes:

Slight flex on work hours, Open to candidates willing to relocate at their own expense

No extensions at this time, Free parking onsite

Estimated once a week, position may work more than 8 hours per day; however, limited to 40 hours per week. Typically, advance notice of OT will be provided 3-4 days in advance.

Lab-based position, primary 70-80%, No exposure to extreme heat or long duration in cold rooms

Interview process: 1st round, interview manager (Zoom), 2nd round, onsite panel interview (unless nonlocal candidate)

Must have skills:

• Purification experience/ Protein purification chromatography
• Critical thinking
• Strong communication
• Professional industry experience is required for bachelor's and master's degree level candidates.
• AKTA must have
• Filtraration
• Must have protein purification
• AV experience, to have
• Bachelor's degree with a minimum of 2 years min of relevant experience
• Master's degree with a minimum of 0+ years, will only consider in school experience only for MS Candidates
• No PHD candidates, overqualified.

Nice to have skills: * DOE/ Design of Experiments a plus * BSL Biosafety Lab Level II experience a plus

Description:

The Genomic Medicine Unit (GMU) is responsible for the design and optimization of viral vector manufacturing processes and platforms. This organization encompasses vector and cell line engineering, upstream and downstream process development, analytics, and clinical manufacturing support.

The GMU purification process development group is responsible for the development of AAV and non-viral vector processes and for supporting viral vector purification from next-generation production platforms to enable high-dose gene therapy programs. The Senior Research Associate (SRA) - Downstream Process Development role requires leadership both inside and outside the laboratory and will rely on industry expertise and the exploration of novel technologies in order to build robust and efficient purification processes consistent with patient safety standards.

We are looking for a candidate with experience in AAV and/or non-viral purification development, scale-up and manufacturing, and technology transfer.

Key Responsibilities:

* Support to develop, design and conduct viral vector purification experiments and evaluate new technologies to increase product yield and process understanding

* Develop, maintain and demonstrate advanced knowledge of principals and techniques in column chromatography and other areas of downstream purification

* Maintain industry knowledge and awareness of new and relevant technologies, and be willing to publish findings and to speak both internally and externally as industry leaders

* Lead / support development of study design, optimization of purification process conditions, media screening and perform troubleshooting experiments and communicate findings with appropriate working groups

* Perform data analyses, contribute to technical reports and internal/external presentations

* Support scale-up activities to implement a manufacturing process based on applied DSP knowledge

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

* Contribute to manuscript and patent writing for external publications and patent applications, respectively

* Self-motivated and display sound technical judgement

* Build a culture of support and collaboration among colleagues

Basic Qualifications

* Master's degree in biological sciences or related discipline, or Bachelor's degree with a minimum of 2 years of relevant experience

* Experience, knowledge and understanding of purification technologies and operations such as:

o Depth filtration

o AKTA or automated protein purification chromatography

o Tangential flow filtration or UF/DF

o Virus clearance and inactivation

o Filtration unit operations at various scales

* Strong grasp of chromatography principles and modalities

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

* Expertise in technical report writing

* Ability to learn and perform viral vector analyses using new tools and techniques

* Exhibits good laboratory practices including writing neat laboratory procedures in lab notebooks

Preferred Qualifications

* Familiarity with purification of viral vectors

* Knowledge of basic analytical tools such as spectrophotometry, ELISA, HPLC, and SDS-PAGE

* Basic understanding of the principles of Quality by Design and ability to apply DOE to downstream development

* Understanding of viral clearance study design and execution strategy preferred

* Experience with large-scale unit operations

* 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

* Ability to build and nurture cross-functional relationships

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

* Ability to stand and work with lab bench equipment in laboratory