Research Associate II

Makro Scientific; Framingham (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Makro Scientific is seeking a Research Associate/Senior Research Associate to support gene therapy product development. This role requires experience in the purification of biologics and the ability to operate in a dynamic manufacturing environment.

Candidates must have a Bachelor's or Master's degree along with relevant experience in chromatography and related operations. The position entails executing ongoing process development activities while collaborating with various departments to achieve project goals.

Qualifications

• Minimum 3 years of relevant experience in the purification of biologics.
• Demonstrated skills in column chromatography, TFF, and depth filtration.

Responsibilities

• Execute ongoing process development activities for gene therapy products.
• Analyze/interpret results and recommend additional experiments.
• Participate in process scale-up activities.
• Author protocols, technical reports, and SOPs.
• Evaluate new technologies for Gene Therapy process development.

Skills

Purification of biologics

Column chromatography

TFF and depth filtration

Education

Bachelor's degree in relevant field (2 years experience)

Master's degree (1-2 years experience)

Bachelor's degree (5 years experience)

Master's degree (3 or more years)

Job description

Growing Pharmaceutical, Biotechnology and Medical Device companies always need TOP Talent. Since 1996, MakroScientific’s proven staffing solutions have helped many Life Sciences companies succeed and visualize their goals by increasing innovation and decreasing costs while maintaining the complex service level expectations.

Our global presence with offices in USA (NJ, PA, IL, CA) and offices in UK, Europe and Asia enables us to be a powerful contributor and connector of right Talent.

Job Description

Duration: 8 Months +

The Research Associate/Senior Research Associate will execute ongoing process development activities for the clinical manufacturing of gene therapy products in compliance with all current regulatory and corporate quality guidelines.

This individual collaborates with all supporting groups and departments to ensure technical and operational requirements are established and maintained in order to meet all relevant company, site and departmental development goals.

• Carry out experiments supporting the generation of a purification strategy for the production of viral gene therapy vectors.
• The individual will analyze/interpret results and may recommend additional experiments that expand process knowledge and improve process performance.
• Participate in process scale‑up activities, including execution of manufacturing scale runs; may act as a subject matter expert supporting the transfer of process technology to both internal and external clinical manufacturing groups.
• Author protocols, technical reports, data analysis summaries, and SOP's.
• Use scientific principles and experiential knowledge to solve complex problems in creative and practical ways.
• Apply state‑of‑the‑art principles and theories in area of responsibility to develop processes and advance programs.
• Evaluate new technologies and make recommendations for their implementation in Gene Therapy process development.
• Adheres to and supports all safety programs by ensuring personnel safety training is completed and safety equipment is available.

Qualifications

Skills: Basic Qualifications:

• Minimum 3 years of relevant experience in the purification of biologics.
• Must have demonstrated skills and working knowledge of the unit operations associated with biologics manufacturing - column chromatography (operation of manual and automated chromatography systems), TFF, depth filtration).

Preferred Qualifications:

• Ability to operate in a dynamic, fast‑paced, safety conscious, multi‑product development and manufacturing environment with shifting priorities.
• Strong commitment to accountability for self and departmental staff for completion of objectives in accordance with established plans.

Education:

• Research Associate: Bachelor's degree and 2 or more years.
• Master's and 1-2 years; Senior Research Associate: Bachelor's degree and 5 or more years.
• Master's and 3 or more years

Additional Information

All your information will be kept confidential according to EEO guidelines.

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