Hybrid Manager, CMC Analytical Development at Careers at Soleno

Summary of Job (brief description)

We are seeking an experienced Manager, CMC Analytical Development, to support our analytical development function. The successful candidate will coordinate outsourced analytical methods development/transfer and testing of drug substance and drug product. The position will also be supporting the authoring of technical reports, SOPs, deviations, change controls, and analytical sections of regulatory filings.

Responsibilities

• Manage the development, qualification, validation, troubleshooting activities, and transfer of analytical methods at contract laboratories. Review analytical data from contract partners, provide feedback, and facilitate resolution of technical or quality issues.
• Manage release testing and stability testing of drug substance and drug product at contract laboratories
• Oversee CMO analytical deviation & quality event investigations, and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.
• Collaborate with other members of the CMC and Quality teams to ensure timely release of clinical products and resolution of product investigations.
• Author and review development reports, deviations, and change control documents.
• Stay current with advancements in analytical technologies and methodologies.
• Manage project timelines and budgets, ensuring compliance.
• Reviews analytical chemistry testing records of raw materials, stability, and product for accuracy and adherence to test methods.
• Participate in cross-functional meetings/teleconferences (internal and external) as appropriate.
• Other duties as assigned

Qualifications

• Bachelor's or master's degree in chemistry, or a related scientific discipline.
• Minimum of 2-4 years of experience in CMC analytical development, with small molecule experience and solid oral dosage forms a must.
• Substantial experience in analytical development techniques used in pharmaceutical industry including HPLC, IC, ICP-MS, GC, NMR, XRD, PSD, and Dissolution.
• Strong background in collaborating with CRO/CMOs for the analytical activities associated with the manufacture of cGMP DSs and DPs.
• Knowledge of GMP quality systems.
• Must possess strong organizational skills and strong attention to details, excellent written and verbal communication skills.
• A problem solver with the ability to successfully and proactively identify and manage potential risks across all relevant areas.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a fast-paced, dynamic environment.

Salary Range: $145,000 - $165,000

(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.)