Job Information
Belcan Senior Research Associate in Marlborough, Massachusetts
Senior Research Associate
Job Number: 350272
Category: Research Scientist
Description: Job Title: Senior Research Associate
Pay Rate: Up to $ 54.05/hr
Location: Marlborough, MA
Zip Code: 01752
Area Code: 508/774
Start Date: Right Away
A Senior Research Associate job opportunity is available with our client in Marlborough, MA. In this role you will be responsible in planning, and execution of projects to ensure timely and successful transition of products from development groups to cGMP manufacture operations. To be considered or this role you will have BS or MS degree in biology, bioengineering, or related scientific field with relevant experience of 4+ years for BS, 2+ years for MS, 0-3 year for PhD in stem cell field and/or in a biotechnology or pharmaceutical industry focusing on cell therapy development.
Senior Research Associate Job Duties:
You will be response to assess production process robustness at sufficient scale with the appropriate level of compliance and documentation suitable for cGMP manufacture.
You will be responsible in developing, scaling up, and codifying processes for existing and new cell-based products suitable for cGMP manufacture.
Perform short and long-term stem cell culture and differentiation experiments including new method/technology evaluation and process optimization/scale up to improve GMP production efficiency.
Able to assess underlying technical challenges and defining the best approaches to achieve suitable processes for cGMP manufacture.
Establish process parameters and improving manufacturing efficiencies
May perform assays such as FCM and RT-qPCR to monitor cell culture quality and stem cell differentiation efficiency.
Ability to execute experiments and summarize results independently and write study report.
Successfully collaborates with Process Science and Technology (PST) team members, as well as with R&D, Technical Operations and GMP Manufacturing departments to ensure smooth integrated process and product development.
Participate in technology transfer from CMC development groups or other Astellas sites to GMP operations including technical training to MFG personnel.
Support manufacturing department activities including training MFG associates, supporting MBR development and review, trending key process parameters across manufacturing batches.
KNOWLEDGE / SKILL / ABILITY / EDUCATION / EXPERIENCE:
BS or MS degree in biology, bioengineering, or related scientific field with relevant experience of 4+ years for BS, 2+ years for MS, 0-3 year for PhD in stem cell field and/or in a biotechnology or pharmaceutical industry focusing on cell therapy development.
Proficient at small to medium scale cell culture process development with solid knowledge of cell biology, drug product/substance manufacturing.
Excellent aseptic skills.
Able to develop, revise, and review SOPs, protocols, batch records, cell culture process development and technical reports.
Excellent written and verbal communication skills.
Detail oriented with good organizational skills and documentation practices to maintain accurate records.
Ability to work productively in a collaborative and cross functional team environment with internal and external partners across multiple scientific disciplines.
Able to manage priorities and maintain timelines for multiple projects in a fast-pace setting.
Ability to work effectively independently, as well as part of a team.
Proficiency using Microsoft Office software (Excel, PowerPoint, Word).
Able to work flexible hours including working in weekends.
Preferred
Knowledge and direct experience with various human cell culture platforms, specially in human pluripotent stem cell culture and differentiation towards products for regenerative medicine.
Experience in process development of cell-based products and automation solutions.
Experience with molecular- and cell-based assays such as RT-qPCR, Flow cytometry.
Knowledge and direct experience in technical transfer and/or GMP manufacturing process and good documentation practices a plus
If you are interested in this Senior Research Associate in Marlborough, MA please apply via the 'apply now' link provided.
Belcan is a global supplier of engineering, technical recruiting, and IT services to customers in the aerospace, industrial, and government sectors. Belcan takes a partnering approach to provide customer-driven solutions that are flexible, scalable, and cost-effective. Our unique capabilities have led to continuous growth and success for nearly 60 years. We are a team-driven Equal Opportunity Employer committed to workforce diversity.
Location: Marlborough , MA
Minimum Experience (yrs): 2 +
Required Education: Bachelor (BA, BS...)
Benefits:
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