SciPro

About the Company

SciPro (formerly Lawrence Harvey Life Sciences) is a people business. We specialise in sourcing, advising and introducing highly skilled life sciences candidates to our client partners across the globe, helping them to achieve their business goals. We provide talent on an executive level, contract, permanent and retained basis to SME, big Pharma businesses and incorporating CRO's and consultancies across the Pharmaceutical, Biotech and Medical Device industries. Our consultants are technically aligned specialists focusing on a single area within Quality, Regulatory Affairs, Clinical Operations & Development, Data Management, Project Management, Medical Affairs, Pharmacovigilance, Market Access & HEOR, Research & Development and Biometrics. The art of recruitment isn't solely about filling jobs, it's about matching people with people and creating harmonious and successful working environments. As a leading staffing specialist with offices in the UK, Europe and North America our biggest USP is representing candidates of all levels across Research & Development, Operational Excellence & Performance, Manufacturing Quality, Compliance, Regulation, Data Management, Cost Optimisation and Innovation. We pride ourselves on being able to deliver to almost every requirement in your business, in any location you need it. Follow us on Twitter @SciProGlobal for latest news and updates.

Listed Jobs

Company Name

SciPro

Job Title

Senior Scientist QC

Job Description

**Job title:** Senior Scientist QC **Role Summary:** Senior QC Scientist responsible for executing, validating, and qualifying analytical methods for viral vector‑based or biologics products in preparation for a BLA submission. Works cross‑functionally with QC and Analytical Development to ensure data integrity, GMP compliance, and readiness for commercial launch. **Expactations:** - Deliver high‑quality QC data on time to support late‑stage manufacturing and regulatory submissions. - Maintain strict adherence to cGMP and regulatory documentation requirements. - Provide technical leadership, troubleshooting, and root‑cause analysis for QC assays. - Communicate findings clearly to regulatory, quality, and development teams. **Key Responsibilities:** - Execute and validate analytical assays, including method development and qualification. - Review and approve QC data, ensuring accuracy, traceability, and compliance with SOPs. - Perform method validation, qualification, and modification in a cGMP environment. - Troubleshoot analytical issues, propose improvements, and implement corrective actions. - Participate in cross‑functional meetings with QC, R&D, and regulatory teams. - Maintain accurate and compliant documentation, including batch records, validation reports, and QC data. - Support BLA documentation by providing robust QC data and supporting materials. **Required Skills:** - Hands‑on laboratory experience in a GMP‑regulated setting. - Proven knowledge of GMP regulations and cGMP documentation practices. - Experience with viral vector or biologics manufacturing and analysis. - Strong analytical, troubleshooting, and data interpretation skills. - Excellent written and oral communication, capable of preparing reports and presenting data. - Ability to work independently and collaboratively in a fast‑paced, regulated environment. **Required Education & Certifications:** - Bachelor’s degree in Life Sciences, Biochemistry, or related field (MD/PhD/PharmD preferred). - Certification in GMP or related quality management system is advantageous. ---

Boston, United states

On site

Senior

05-11-2025

Company Name

SciPro

Job Title

Director Program Management

Job Description

**Job Title:** Director, Program Management **Role Summary:** Lead cross‑functional program management for clinical and preclinical assets in a biotech focused on autoimmune therapies. Drive execution of development plans, milestone alignment, risk mitigation, and operational readiness across research, CMC, regulatory, and clinical functions. **Expectations:** - Manage integrated development schedules for multiple early‑phase clinical and preclinical programs. - Ensure timely delivery of key milestones and maintain accountability across teams and external partners. - Provide clear, data‑driven status reporting and dashboards to senior leadership. **Key Responsibilities:** - Coordinate program activities across research, CMC, regulatory, and clinical operations. - Build, maintain, and update Gantt charts and integrated development plans. - Identify and mitigate program risks proactively. - Support operational readiness for milestone reviews and regulatory submissions. - Manage alliance relationships with external collaborators and CROs. - Develop program dashboards, trackers, and status reports for leadership. - Lead cross‑functional meetings, capture action items, and follow up on deliverables. **Required Skills:** - Program management in biotech/pharma, with 5+ years managing clinical‑stage programs. - In‑depth knowledge of drug development, clinical operations, and CMC interfaces. - Proficiency in Gantt chart software (e.g., Smartsheet, MS Project) and risk management tools. - Strong organizational, communication, and collaboration abilities. **Required Education & Certifications:** - Bachelor’s degree in a scientific or technical discipline. - Advanced degree (MS, MBA, or PhD) preferred.

United states

Remote

10-11-2025