Job Title: Senior Research Associate, MS&T Location: Marlborough, MA 01752 Duration: 06 Months (chance to extend/convert to perm)
Purpose & Scope:
Within MA-TC’s Manufacturing Science and Technology (MS&T) team, this individual will be responsible in planning, and execution of projects to ensure timely and successful transition of products from development groups to cGMP manufacture operations. The individual will be response to assess production process robustness at sufficient scale with the appropriate level of compliance and documentation suitable for cGMP manufacture.
Activities will focus on optimizing manufacturing processes for cell-based products destined for various clinical applications.
This individual will be responsible in developing, scaling up, and codifying processes for existing and new cell-based products suitable for cGMP manufacture.
Essential Job Responsibilities:
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 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
Assist in lab material inventory management and equipment maintenance. ?
Required Qualifications:
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.
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.
Proficiency using Microsoft Office software (Excel, PowerPoint, Word).
Able to work flexible hours including working in weekends.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $50.00/hr.
