Associate Director/Director, Bioanalytic Development & Operations (Waltham, MA)
- Lead and oversee the development, validation and application of bioanalytical techniques (LC-MS, ELISA, MSD, PCR, cell-based assays) to support PK, PD, biomarker and immunogenicity objectives in non-clinical and clinical studies
- Serve as the departments subject matter expert and be a team resource for bioanalytical knowledge, strategy and application in drug development
- Leverage depth of knowledge and hands-on experience with bioanalytical techniques to advise on assay design, method validation design, and interpretation of method performance data.
- Coordinate and supervise studies conducted at CROs including generation of proposals and SOWs, data generation and analysis, and troubleshooting.
- Author and review bioanalytical reports or summary sections for preclinical/non-clinical/clinical reports, and regulatory documents for initiation of clinical studies (such as IND and CTA) and drug approvals (such as NDA and MAA)
- Prepare, track, and maintain all necessary regents and documentation associated with bioanalytical assays
- Oversee and coordinate collection, processing, storage, and reconciliation of clinical trial samples
- Manage, monitor and document sample transfer between clinical sites, central labs, and testing labs.
- Collaborate with discovery, non-clinical and clinical teams to generate reagents and develop assays to meet project timelines.
- Stay abreast of literature, government guidelines, and internal guidance as relates to the development and use of bioanalytical methods
- Requires a BS in biological field and a minimum of 10 years’ relevant biotechnology industry experience; or an MS degree with a minimum of 8 years’ experience; or a PhD and a minimum of 5 years’ of experience
- Experience with development and qualification of PK/PD and immunogenicity assays in ELISA, MSD and other formats in both human and animal matrices
- Deep scientific and technical experience with and understanding of therapeutic antibody non-clinical and clinical development
- Excellent time management skills and the ability to work with a sense of urgency in a highly collaborative team environment
- Strong oral and written communication including the ability to present information clearly and logically
- Ability to prioritize and manage multiple projects to meet critical deadlines
- Strong attention to detail and problem-solving skills
- Works effectively in a team environment
- Strong commitment to ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- The salary range for this position is commensurate with experience
Recommended Jobs
Senior Manager, Global Regulatory Labeling Strategy - Remote
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda…
Merchant Consultant - Bilingual in Chinese
Are you ready to go uP? We are named in Top Workplaces NYC for 2024 We are one of the winners of USPAACC’s Fast 100 Asian American Business awards We are recognized as one of the Top 5000 in …
Planning and Zoning Coordinator
The Town of Sandwich, MA is seeking a full-time, 40 hour per week, Planning & Zoning Coordinator who will administer Historic District Committee, Zoning Board of Appeals and Planning Board regulatory…
Press Room Operator - 2nd shift (Holyoke)
Description: The TSUBAKI name is synonymous with excellence in quality, dependability, and customer service. U.S. Tsubaki is a leading manufacturer and supplier of power transmission and motion contr…
Order Fulfillment Associate Supervisor Full Time
BJ's Wholesale Club, an esteemed leader in the membership-only warehouse retail market in the Eastern United States, seeks a dedicated and dynamic Order Fulfillment Associate Supervisor to join our th…
Executive Director, Business & Digital Platforms Lead
Company Overview Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target musc…
Qa/qc Analyst
Hiring for a Quality Assurance Specialist (Contract - 100% Remote)! Location: Remote (Worksite based in Hadley, MA) Duration: 6 months Schedule: Full Time: Monday-Friday, 8:00 AM-5…