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Senior Analytical Scientist - Chromatography
$151k-185k (estimate)
Full Time | Business Services 1 Month Ago
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KP Recruiting Group is Hiring a Senior Analytical Scientist - Chromatography Near Boston, MA

KP Recruiting Group is a consulting firm that provides leadership and exceptional talent to some of the world’s leading companies. Headquartered in the Midwest, KP Recruiting Group has successfully completed countless engagements across the United States. We represent clients in all industries and all sizes. Our mission is to provide exceptional client and candidate experiences in order to get the best possible results. On behalf of our client, we are excited to present the following confidential role. We look forward to hearing from you and discussing the opportunity!

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The Role:

The Analytical Development group has the overall responsibility to develop, qualify, and validate robust analytical methods to support release and characterization testing of early-stage protein therapeutic candidates, while also performing cGMP sample testing for the purpose of drug substance and drug product lot release and stability testing (Ph I/II). Main analytical platforms in use include spectrophotometry, enzyme activity/kinetics, capillary electrophoresis, and liquid chromatography.
We are looking for a skilled, highly motivated individual with expertise in analytical method development who works well in a team-setting to meet project goals within the established timelines. In addition to mentoring and training junior analysts, a significant part of this role consists of performing hands-on laboratory activities as an individual contributor and may include a leadership role in protein therapeutic development.
Key Responsibilities
Perform analytical method development, qualification, validation, and troubleshooting as required for various biochemical platforms such as capillary electrophoresis and HPLC/UPLC (Size exclusion chromatography, Ion exchange chromatography, reversed phase HPLC, and Hydrophilic Interaction Chromatography (HILIC) using a variety of detection modes, as well as other analytical methodologies such as binding assays, depending on project needs.
Design, execute, and interpret laboratory experiments and data with appropriate controls.
Ensure timely completion and delivery of analytical results and documentation (ELN, technical reports, SOPs, etc.) including clear and concise technical data presentation and discussion with adherence to GxP requirements and ICH guidelines. Present on technical aspects internally and externally.
May participate in and/or manage analysts involved in cGMP sample testing, following method protocols (SOPs) and generating data packets with LIMS entries for results. Lead investigations into deviations and CAPA resolutions as appropriate. Provide guidance and mentorship to junior staff.
May participate in program management, including interfacing with other departments and/or 3rd party contract laboratories. 
Maintain a GMP compliant laboratory environment.

Requirements

Basic qualifications
Ph.D. in Biochemistry, Analytical Chemistry, or related discipline with 4 years of relevant experience working in the biotechnology/pharmaceutical industry, or a master’s degree and at least 8 years of relevant experience or a bachelor’s degree and at least 10 years of relevant experience.
Expertise and proven ability to apply his/her knowledge to establish analytical methods for monoclonal antibodies and other complex proteins is expected. A strong background in method qualification of protein analytical methods, excellent instrument and method troubleshooting skills, as well as knowledge of various data analysis approaches for HPLC, CE-SDS, and cIEF are required.
Proven ability to adhere to good documentation standards and maintain detailed records of all work performed.
Proven capability of evaluating/developing new technologies in an independent manner and be able to propose/design implementation strategies if deemed appropriate.
Preferred Qualifications
Expertise in protein separations such as HPLC, CE-SDS, and cIEF.
Experience in application of mass spectrometry (MS) to facilitate method development, release and stability monitoring of protein therapeutics.
Proficiency with the use of tools such as Chemstation, OpenLab, Empower, and/or Softmax, as well as familiarity with software packages to perform statistical analysis (JMP, etc.).
Experience with people management.
Working experience in a GMP environment and ability to adhere to all appropriate GMP standards (e.g., invalid result investigations, deviations, and CAPAs).
Ability to write and communicate scientific data effectively.
Experience with and/or knowledge of the regulatory requirements for early-stage biologics development including knowledge of appropriate control and testing strategies.

Benefits

  • 401k Matching
  • Family and Individual Insurance Packages (Health, Life, Dental, and Vision)
  • Paid Time Off & Paid Holidays
  • Long & Short-Term Disability
  • Identity Theft Plans
  • Retirement & Pension Plans
  • Employee Assistance Program
  • Employee Referral Program
  • Tuition Reimbursement Programs
  • Advancement & Professional Growth opportunities 
  • Parental Leave
  • & More

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$151k-185k (estimate)

POST DATE

03/09/2024

EXPIRATION DATE

05/08/2024

WEBSITE

kprecruiting.com

HEADQUARTERS

Minneapolis, MN

SIZE

<25

INDUSTRY

Business Services

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