Sr. Research Scientist II, Analytical Development

SENIOR RESEARCH SCIENTIST II, ANALYTICAL DEVELOPMENT in Hopkinton, MA

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. 

The Analytical Department is responsible for testing support of biologics clinical development programs. The routine functions of the laboratory are testing of raw materials, in-process, end product, and stability samples. The Senior Research Scientist II’s principal responsibility is the design, development, validation and implementation of analytical procedures. In addition, the individual will collaborate closely with internal process development, manufacturing, and quality groups as well as clients to help ensure successful delivery of programs. This position is based at Curia Biologics’ manufacturing facility in Hopkinton, MA and reports to the Director, Analytical Development.

 Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture. 

 We proudly offer

• Generous benefit options (eligible first day of employment) 
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities 
• Education reimbursement
• 401k program
• Learning platform
• And more! 

 

Supervisory Responsibilities

This position may have supervisory duties.

 

Responsibilities

• Applies research knowledge to plan and manage complex and/or multiple project(s)/program(s). Develops strategies and/or policies that guide project(s)/program(s); proposes new initiatives or policies. Leadership in problem-solving may extend beyond team to other scientists and other labs. 
• We are particularly interested in individuals who bring with them extensive experience and a strong knowledge of both physical analytical procedures for nucleic acids and proteins using HPLC, UPLC, ELISA, CE or cIEF as well as binding and cell-based biological assays.
• Work on unusually complex technical problems and provide solutions which are highly innovative and ingenious.
• Plans and delivers on-the-job training.  Assignments are often self-initiated. 
• Consults and/or makes recommendations in the area of research or program policy through effective verbal and written communication about the research project(s)/program(s). 
• Provides estimates of manhours, materials and service fees for proposals.
• Works closely with external vendors or Curia sites for analytical tests not performed in Hopkinton.
• Establishes goals and objectives of the project(s)/program(s), sets and changes deadlines; plans, assigns and analyzes work of others.
• Present scientific data and timelines to clients.
• Develop efficient, selective analytical procedures for assigned compounds. Process samples with developed method in an efficient manner.
• Expertise in multiple lab analytical techniques.
• Recommend and implement methods to increase the quality of products and/or services.
• Conduct laboratory operations in a safe manner.  Maintain familiarity with the Chemical Hygiene Plan.  Exhibit safety awareness and safe work practices.
• Follow responsible actions regarding chemical disposal.  Maintain compliance with all regulations at the federal, state, and local levels.
• Find new and better ways of performing job by challenging established procedures. 
• Perform other related duties as may be reasonably assigned in the course of business.

 

Qualifications 

Education, Experience, Certification, and Licensures

• PhD/MS/BS in a relevant Scientific field with at least 5 years of experience in Analytical Development in the Biotech industry, preferably in biologics drug development.
• Proven track record of leading analytical development in a GMP-regulated environment and collaborating with operations and Quality teams.
• Demonstrated success in the development, transfer, qualification and validation of biologics based analytical methods using the ICH, FDA and EMA guidel