Manager, Analytical Development and Quality Support

Position Summary

The Manager, Analytical Development and Quality Support is responsible for supporting the execution and oversight of analytical activities for the development and commercialization of protein therapeutics. This role requires a scientifically driven individual with hands-on experience performing and interpreting analytical methods commonly used for biologics stability assessment and quality control testing.

Reporting directly to the Head of Analytical Science and Technology, the successful candidate will work closely with internal technical teams and external contract development and manufacturing organizations (CDMOs) to oversee stability programs, review analytical data, verify testing results, and support regulatory-quality documentation. The position requires strong technical expertise, attention to detail, excellent communication skills, and familiarity with GMP-regulated environments.

Key Responsibilities: Analytical and Stability Program Support

• Serve as a technical liaison with CDMOs and contract testing laboratories.
• Coordinate and oversee product stability studies, including protocol execution, sample management, testing schedules, data trending, and reporting of stability results.
• Review and interpret analytical data to support product development, process characterization, comparability assessments, and product stability.
• Review analytical protocols, reports, raw data summaries, Certificates of Analysis (CoAs), and data packages generated by external laboratories to ensure completeness, accuracy, and compliance with specifications and GMP requirements.
• Evaluate analytical investigations, deviations, out-of-specification (OOS) results, change controls, and technology transfer activities associated with outsourced testing.
• Prepare and maintain Certificates of Analysis (CoAs), specification sheets, analytical summaries, and other quality documentation.
• Compile, organize, analyze, and trend analytical data from multiple sources to support development, quality, regulatory, and product lifecycle activities.
• Collaborate with Quality, Process Development, Manufacturing, Regulatory Affairs, and external partners to support analytical strategies and product lifecycle activities.
• Participate in technical discussions regarding analytical methods, product quality attributes, stability trends, and testing strategies, and communicate findings through reports, presentations, and cross-functional meetings.

Requirements

Qualifications

• Bachelor's degree in Biochemistry, Chemistry, Biology, Pharmaceutical Sciences, Chemical Engineering, or a closely related scientific discipline.
• Minimum of 4 years of experience in a Quality Control (QC), Analytical Development, Process Development, or related laboratory environment supporting biopharmaceutical products.
• Hands-on experience executing analytical methods used for protein therapeutic development, release, stability and characterization analysis.
• Experience working within GMP-regulated environments.
• Experience reviewing laboratory data, technical reports, and analytical documentation.

Preferred Technical Experience

• Experience with one or more of the following analytical techniques is highly desirable:
• Size Exclusion Chromatography (SEC-HPLC/UPLC)
• Reversed Phase HPLC (RP-HPLC)
• Ion Exchange Chromatography (IEX)
• Capillary Electrophoresis (CE-SDS, icIEF)
• Protein concentration determination methods such a SoloVPE
• Endotoxin and bioburden testing
• Aggregation and purity assessments
• Stability-indicating analytical methods

Competencies

• Strong understanding of protein therapeutics and biopharmaceutical analytical testing.
• Excellent written and verbal communication skills.
• Strong organizational skills and attention to detail.
• Ability to review, interpret, and critically evaluate complex analytical datasets.
• Demonstrated ability to manage multiple priorities in a fast-paced environment.
• Effective collaborator with internal and external stakeholders.
• Proficiency with Microsoft Office applications and electronic data management systems.

Benefits

Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.