Senior Scientist, Bioanalytical Sciences
13 hours ago
About Us
Crescent Biopharma's vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company's pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, follow the Company onLinkedInandX.
Position Overview
Crescent is seeking a Senior Scientist, Bioanalysis to manage bioanalytical activities supporting preclinical and clinical programs. This individual will partner with internal teams and CROs to design, validate/transfer, and oversee bioanalytical assays (e.g., ligand-binding and LC–MS/MS), managing sample analysis, data quality control, interpretation, and reporting to generate high-quality concentration data supporting PK. Responsibilities include planning and authoring bioanalytical documents (plans, protocols, reports), ensuring data integrity and regulatory compliance (GLP/GCP), and managing the operational aspects of outsourced work (budgeting, SOWs, audits, and sample logistics).
Responsibilities- Assist in the development and execution of bioanalytical (BA) strategies to meet current and future regulatory and scientific requirements.
- Manage the implementation of bioanalytical contracts/SOW, plans, and reports.
- Oversee day-to-day operations of CROs: coordination of shipments of test article, necessary reagents and samples, protocol and data review, provide technical assistance, and report review.
- Work with internal and external subject matter experts and other relevant disciplines to manage and resolve scientific, technical or quality issues and improve study consistency, quality, efficiency and effectiveness.
- Coordinate the bioanalysis activities for individual preclinical/clinical programs to ensure alignment of BA data deliverables.
- Contribute to regulatory documents (i.e. IND, CTA, BLA etc.), providing high-quality bioanalytical content and responses to queries.
- Conduct scientific audits of CROs in collaboration with the QA department.
- Instill and adhere to GLP and GCP regulations, relevant SOPs, protocols, policies and safety procedures.
- PhD or MS in Chemistry, Pharmaceutical Sciences, Pharmacokinetics or related discipline with a minimum of 5 years of industry or related experience.
- Strong understanding of bioanalytical technology and methods both for small and large molecules and peptides.
- Proven experience managing external CROs (SOWs, timelines, budgets, data review) with excellent organizational and project-management skills.
- Well-grounded in drug-development practices—data-driven decision making; contribution to protocols, bioanalytical plans/reports, and clinical study reports.
- Ability to work in a dynamic team-oriented environment as demonstrated by participating in and contributing to cross-functional teams.
- Small molecule DMPK experience is a plus.
- Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment.
- Competitive compensation, including base salary, performance bonus, and equity.
- 100% employer-paid benefits package.
- Flexible PTO.
- Two, one-week company-wide shutdowns each year.
- A commitment to your professional development, with access to resources, mentorship, and growth opportunities.
__
Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.
#LI-CBIO
-
Waltham, Massachusetts, United States Upstream Bio Full timePosition Summary:The translational Sciences group at Upstream Bio is looking for a Principal Scientist/Associate Director, Bioanalytical Sciences who will lead the development and implementation of critical bioassays to support development programs and provide scientific and operational oversight of bioanalytical sample analyses.You will represent the...
-
Executive Director, Bioanalytical Development
24 hours ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and...
-
Senior Data Scientist, Costing
13 hours ago
Waltham, Massachusetts, United States Xometry Full timeXometry (NASDAQ: XMTR) powers the industries of today and tomorrow by connecting the people with big ideas to the manufacturers who can bring them to life. Xometry's digital marketplace gives manufacturers the critical resources they need to grow their business while also making it easy for buyers at Fortune 1000 companies to tap into global manufacturing...
-
Waltham, Massachusetts, United States BioSpace Full timeCSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a...
-
Waltham, Massachusetts, United States MaxCyte, Inc. Full timeDescriptionWe are seeking a highly motivated Bioinformatics Scientist to join our interdisciplinary R&D team focused on developing innovative analytical tools and assays that assess the off-target safety profiles of CRISPR-based gene editing systems. The successful candidate will bring deep expertise in bioinformatics, genomics, and next-generation...
-
Waltham, Massachusetts, United States Crescent Biopharma , Inc. Full timeAbout UsCrescent Biopharma's vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company's pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance...
-
Senior Manager, Data Science
2 weeks ago
Waltham, Massachusetts, United States Alkermes Full time $200,000 - $250,000 per yearJOB DESCRIPTIONPosition SummaryAs a Senior Manager, Data Science within the INDIGO | AI Innovation Lab, you will play a hands-on role in developing analytical, traditional ML, and AI products and in supporting delivery of prioritized AI use cases on our roadmap. You will collaborate with business stakeholders on specific deliverables, maintain ownership of...
-
Senior Manager, Pharmacovigilance Scientist
1 week ago
Waltham, Massachusetts, United States Kailera Therapeutics, Inc. Full time $136,000 - $170,000At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions. We...
-
Director, Data Science
2 weeks ago
Waltham, Massachusetts, United States Xometry Full timeXometry (NASDAQ: XMTR) powers the industries of today and tomorrow by connecting the people with big ideas to the manufacturers who can bring them to life. Xometry's digital marketplace gives manufacturers the critical resources they need to grow their business while also making it easy for buyers at Fortune 1000 companies to tap into global manufacturing...
-
Senior Data Scientist
2 days ago
Waltham, Massachusetts, United States Boston Dynamics Full timeAs a Data Scientist at Boston Dynamics, you will work to understand, measure and communicate insights about our business and products from telemetry and semi-structured databases. Your focus will be on modeling the performance and lifecycle of our products, drawing on manufacturing quality data, operational telemetry, service records, and ERP transactions....