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Senior Scientist I- Immunoassay Bioassay
4 months ago
Pharmaron (Boston) is seeking a talented Senior Scientist I to join our dynamic Immunoassay Bioanalysis Laboratory team in Woburn, MA. As a key member of the team, you will lead the development and validation of immunoassays to detect/monitor biologic drug candidates in clinical and preclinical settings.
Position Description
The Senior Scientist I will play a pivotal role in propelling drug development forward through the creation and validation of PK/PD, ADA, and soluble protein biomarker immunoassays. Your expertise will be essential in training colleagues, authoring protocols, reports, and SOPs while providing vital scientific and technical support. Contribution to process enhancements, cross-functional collaboration, and strict adherence to regulatory standards will be instrumental in driving the success of our dynamic laboratory.
Principle Duties and Responsibilities
- Lead the development and validation of PK/PD, ADA, and soluble protein biomarker immunoassays in a drug development setting.
- Provide support in obtaining reference materials, control plasma, and project-specific consumables to meet the objectives of the study.
- Assist in training personnel in the operation, maintenance, and troubleshooting of laboratory equipment, techniques, assays, methods and immunoassay platforms.
- Authors and reviews SOP's, protocols, and reports for use by the company, as needed.
- Contribute to department initiatives and process improvements.
- Complies with company Standard Operating Procedures.
- Carries out laboratory tasks and works with other laboratory staff to progress study-specific experimental work and, as necessary, supports non-study-specific laboratory duties.
- Provides scientific and technical support to colleagues in the Business Development group when requested.
- Serve as a scientific resource by providing accurate and timely information to sponsors.
- Contributes to the training, monitoring, and mentoring of staff.
- Assists with scientific investigations and efforts to troubleshoot/solve assay problems.
- Prepares data tables and reports within Laboratory Information Management Systems (Watson™).
- Demonstrate the desire to be career upwardly mobile and take on new responsibilities as you contribute to growing our business.
- Taking initiative and solving complicated problems.
- Perform other assigned tasks as required.
Requirements:
- Bachelor's Degree or higher degree in a scientific-related discipline.
- 4-7 years or more of immunoassay development experience at a CRO/pharma/biotech focused on biologic drug development.
- 3-6 years of validating immunoassays in a GLP laboratory.
- Previous experience with Meso Scale Discovery (MSD), Watson LIMS, and ELISA.
- Previous experience with Gyros or Ella and Electronic Notebooks (preferred).
- Strong professional communication skills and attention to detail.
- Full understanding of regulatory requirements as outlined in the FDA's Bioanalytical.
- Method Validation Guidance for Industry.
- Strong work ethic, self-motivation, and ability to thrive in a dynamic team environment.
- Proficiency with Microsoft Office products, including Excel, Outlook, PowerPoint, and Word.
Benefits
Pharmaron cares about our work community and offers a variety of benefits, allowing employees to customize a benefits package that meets their personal needs. Company benefits include the following:
- Medical, Dental & Vision Insurance Plan with Employer Contribution
- Health Reimbursement Account Funded by Employer
- Healthcare & Dependent Care Flexible Spending Accounts
- Employee Life and AD&D Insurance 100% Employer Paid
- Voluntary Life and AD&D Insurance for Employee, Spouse & Child(ren)
- Short and Long Term Disability 100% Employer Paid
- 401k with Employer Match
- Employee Assistance Program
About Pharmaron
Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With over 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.
Pharmaron is proud to be an Equal Employment Opportunity and Affirmative Action employer.
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