About the Role

The Manager II, Quality Control/Stability is responsible for various analytical activities related to commercial stability program management of drug substance and drug product; coordinating GMP activities and ensuring batches are tested and released to meet project timelines for commercial needs. This position is responsible to manage partner organizations, contract drug product manufacturer testing labs, contract testing labs and contract API testing labs. This position will support Quality management for budget proposals. In addition, this position will be responsible for review of outsourced analytical reports, authoring in-house analytical reports, generation of certificates of analysis and participate in review of quality agreement creation and revision. This position will perform SME review and approval of laboratory investigations for deviations and OOS', initiation and review of change controls for test method revision and specifications for API and drug product, data trending for release and stability data and management of stability and reference standard programs.

Let's talk about some of the key responsibilities of the role:

• Oversee and manage analytical and stability activities at external partners ( CMOs) for commercial
• Review analytical data associated to commercial stability
• Establish and implement quality control processes to support commercial
• Develop effective relationships with external partners and actively manage these
• Develop timelines, identify critical analytical issues, lead problem solving of technical issues, investigate and resolve OOT/OOS results.
• Provide in-depth technical support on investigations, deviations, and trend
• Review commercial analytical methods, validation protocols and
• Demonstrate a good understanding and experience of various analytical methodology in a QC/commercial setting (e.g., HPLC, dissolution, GC, KF, )
• Review, tabulate, summarize, and analyze stability results for inclusion for FDA annual reports and annual product review (APR).
• Review, tabulate summarize and analyze release data for inclusion of APR.
• Generate stability reports for commercial drug
• Actively participate with the CMC and Quality teams in resolution of technical issues, in support of validation, manufacturing, commercial production, release and stability of products.
• Work cross-functionally with Manufacturing, and Quality Assurance to assess and resolve quality issues and provide solutions with regards to issues impacting the release of product/lot
• Issue Test Record Review forms and Certificates of Analysis for drug substance and commercial drug product.
• Familiarity with electronic systems, including developing and producing reports using Microsoft Office (Excel). Proficiency with electronic management systems (such as LMS and QMS).
• Support regulatory filings including NDAs, PAS, CBE-30, Annual Reports, and other documents for filings.
• Author, read technical papers, reports,
• Assist as a SME for audits of contract laboratories and regulatory inspections.

Factors for Success:

• 8 years of drug quality control experience with MS (or) 3 years of experience with PhD, working in the pharmaceutical or biotechnology industry; preferred degree in Physical Sciences, Pharmaceutics, Analytical Chemistry, Organic Chemistry or
• In-depth knowledge of global GMP stability
• In-depth knowledge of commercial stability programs.
• Strong experience in leading Quality Events investigations, Root Cause Analysis (RCA), and CAPA implementation.
• Knowledgeable of management of Laboratory data management system for commercial
• Knowledgeable in continuous improvement efforts and to lead continuous improvement projects as assigned.
• Detailed knowledge and understanding of CGMP related to QC laboratory and ability to identify/remediate gaps in processes or systems.
• In-depth understanding of ICH, compendial, FDA, cGMP, and CMC guidelines and requirements and industry best practices.
• Hands-on experience with common analytical methods for the testing of small molecules such as HPLC/UPLC, LC-MS, dissolution, Karl Fischer titration, and
• Thorough knowledge of cGMP regulations, quality systems and regulatory requirements, including 21 CFR 210/211/600s, USP and ICH Guidelines; Experience in and strong knowledge of sterile manufacturing
• Superior interpersonal and communication skills for interactions with technical personnel at contract facilities, cross-cultural team skills.
• Experience managing third party contractors is
• Excellent writing and presentation
• Multi-tasking, strong organizational skills and detailed-
• Team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with a courtyard, table tennis, snacks and drinks, and occasional catered We provide a hybrid work environment; three days a week onsite with two days remote.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to the Associate Director, Quality Assurance
• Some travel may be required – 15% (including international travel)

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $107,200 - $150,200 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://alliantbenefits.cld.bz/tarsus2024BenSnapshot

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