Sr. Manager/Associate Director, Stability, Malvern, Pennsylvania

The Sr. Manager/Associate Director, Stability, will manage and coordinate all aspects of stability studies for clinical and commercial products. This position has demonstrated the knowledge, experience, and skills necessary to manage the development, improvement, and execution of stability programs for clinical and commercial products. Ensure that the stability protocols are approved, stability pulls are timely at the vendor sites and the stability data is updated and tracked for data management and trending programs. Assessing, improving and maintaining local, regional and global regulatory compliance (ICH, GMP, GLP, etc.) are integral responsibilities of this position.

Duties and responsibilities

Responsibilities include:

• Implement and manage a stability database system for all development and clinical/commercial programs.
• Support product release, stability, raw materials, method lifecycle, reference standard qualification, and laboratory compliance for clinical and commercial products.
• Oversee and manage external stability studies including establishing appropriate developmental and clinical/commercial stability protocols.
• Understand stability and statistic principles. Perform statistical analysis, perform trend analysis, evaluate and interpret stability study data.
• Recommend expiry/retest periods and author/issue stability retest reports as required.
• Serve as a liaison to communicate stability strategy to other functional teams or units.
• Identify, write, revise, manage and implement standard operating procedures, work instructions, standard practices, protocols and reports.
• Draft stability sections of INDs and NDAs. Prepare accurate stability summary reports for CMC regulatory submissions, annual reports, and periodic updates to RA or QA.
• Support completion of quality audit responses via any related updates to reported stability data, summaries, SOPs or other corrective action required.
• As stability trending SME, participate in specification setting reviews and specification life-cycle management.
• Organize, participate and guide stability review meetings as required.
• Serve as lead contact for all stability-related external laboratory investigations and deviations as needed.
• Manage updates to storage and transportation requirements for GMP materials and issue reports for temperature excursion events.
• Maintain up-to-date knowledge of government regulations and Venatorx policies and procedures.

Qualifications

Candidate requirements:

• PhD, MS, or with relevant industry experience. (PhD with 6+, MS with 8, and BA with 10) years of experience in analytical chemistry or related life sciences discipline.
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to stability study design, expiry dating, and analytical method qualification/validation for biologics and vaccines.
• Strong understanding of various analytical chemistry methodology principles, and track record of validation for GMP release and stability testing, and stability trouble shooting.
• Solid understanding and hands-on experience of applying basic statistical tools for stability data trending and rate analysis to support retest period/ shelf-life proposals is preferred.
• Experience in IND, NDA and BLA submission is highly preferred.
• Experience working in a regulated (GLP / GMP) environment.

This is a representative description of the job and is not intended to be all-inclusive. Employee may perform other related duties as required to meet the ongoing needs of the organization. Duties, responsibilities, and activities may change at any time with or without notice.

Venatorx is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, marital status, protected veteran status, disability status, or any other status protected by federal, state, or local law.

For more information, please check out our website: www.venatorx.com