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SENIOR RESEARCH SCIENTIST I, 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 I’s principal responsibility is the design, development, validation and implementation of analytical procedures with a focus on cell based assays. 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.

Essential job duties

• Work on technical problems and provide solutions for cell culture based assay programs such as reporter (FC effector, TLR activation), flow based binding, viability, internalization, ADC bioassay, T cell activation.

• Highly skilled in cell culture analytical techniques.

• Strong knowledge of both physical analytical procedures (HPLC, ELISA, CE, cIEF, MS, PCR, Octet etc.) as well as binding assays.

• Applies research knowledge to plan and manage complex and/or multiple project(s)/program(s). Works with senior scientific personnel to execute strategies and/or policies that guide project(s)/program(s); implements new initiatives or policies. Support in problem-solving may extend beyond team to other scientists and other labs.

• Schedules and delivers on-the-job training. Assignments are developed in conjunction with management direction.

• Provides feedback in the area of research or program policy through effective verbal and written communication about the research project(s)/program(s).

• Author development reports, qualification protocols, qualification reports, SOP’s supportive of IND filings.

• 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.

• Tracks goals and objectives of the project(s)/program(s), sets and changes deadlines; plans, assigns and analyzes work.

• Present scientific updates to clients.

• Develop efficient, selective analytical procedures for assigned compounds. Process samples with developed method in an efficient manner.

• Proficient 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.

Education, experience, certification and licensures

• 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 guidelines and regulatory requirements.

• Multiple years of management experience overseeing staff with a variety of skill and educational levels in CDMO environment.

Knowledge, skills and abilities

• Understanding of GMP and ICH principles

• Strong interpersonal/written communication, collaboration and problem-solving skills.

• Flexible and adaptable in constantly changing environments and growing organization.

• Maintains extremely high quality and efficiency standards.

• Contribute to a positive team-focused company culture.

  Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

  We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

  All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

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