Scientist, II-QC Analytical Development

PCI Pharma Services • Bedford, NH

15d

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Analytical Development Scientist II to take a leading role in method development, validation, and transfer activities that support the full product lifecycle—from clinical to commercial programs—as well as R&D initiatives. As a member of the team, you’ll apply your deep technical expertise to lead projects, mentor junior staff, and collaborate cross-functionally. Your work will directly impact the quality, reliability, and efficiency of our pharmaceutical development and manufacturing operations.

Requirements

• Education/Experience : Bachelor’s degree in a scientific discipline with 5+ years of relevant experience, OR Master’s degree with 5+ years in a cGMP laboratory environment.
• Technical expertise : Extensive hands-on experience with analytical techniques (HPLC/UPLC, GC, CE, ELISA, FTIR, UV/VIS, Karl Fisher, SDS-PAGE, particle size analysis, pH, osmometry).
• Regulatory knowledge : Strong working knowledge of cGMP, ICH, USP, and global compendial guidance.
• Skills : Excellent problem-solving, technical writing, and project management abilities; proficiency in MS Office and lab-based data systems.
• Attributes : Detail-oriented, resilient, collaborative, and adaptable in a fast-paced environment.

Nice To Haves

• Experience in a contract development/manufacturing organization (CDMO).

Responsibilities

• Lead method development & validation : Develop, validate, and transfer analytical methods using HPLC/UPLC, CE, ELISA, FTIR, KF, UV/VIS, and more in compliance with ICH and GMP guidelines.
• Execute complex testing : Conduct analytical testing to support process development, method transfers, and validation activities.
• Ensure compliance : Document laboratory work in accordance with GDP requirements; author and review protocols, reports, technical summaries, and SOPs.
• Problem-solve & innovate : Troubleshoot method and instrumentation issues, propose solutions, and bring in new technologies to improve efficiency, robustness, and compliance.
• Drive efficiency : Independently manage multiple projects, ensuring timelines, quality, and cross-team collaboration.
• Support quality systems : Participate in cleaning validations, method qualifications, and audit readiness as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level