The Associate Director, Quality Control has responsibility for actively overseeing cGMP quality control activities associated with development and commercialization of the company’s small-molecule assets. This function operates within a virtual (100% outsourced) business model and the incumbent will be responsible for oversight of Quality Control activities of drug substance, drug product, intermediates. The individual must be knowledgeable of US government regulations (ICH, GMP, GLP, etc. A thorough understanding of the drug development process as related to methods development, validation, and transfer is also required. An in-depth knowledge of release/stability testing, specification setting, reference standard maintenance and quality assurance/regulatory practices is also necessary to fulfill the requirements the requirements for this position.

Duties and responsibilities

Responsibilities include:

• Understand test methods, validations and stability testing for raw materials, excipients, drug substance and drug products. Contribute to the development, improvement and optimization of methods for release and stability.
• Practical understanding of pharmaceutical drug development and GxP requirements is essential.
• Extensive experience in chromatographic (HPLC/UPLC, GC, IC) data review is required.
• Working knowledge of other GMP testing including but not limited to microbiological, wet chemical techniques and metals analyses is required.
• Manage and support method transfer and validation activities to external sites. Provide review and approval of related documentation.
• Identify, write, and revise standard operating procedures, work instructions, and laboratory policies, procedures and standard practices. Review methods, protocols, reports, IND and NDA sections as appropriate. 
• Initiate and/or support change controls, laboratory investigations, CAPAs and deviations as appropriate. Participate with external laboratory investigations.
• Responsible for working with external partners for analytical method validation life-cycle management and process improvement.
• Participate in CMC technical meetings as support for QC and analytical functions.
• Contribute as author/reviewer of appropriate analytical IND and NDA sections.
• Support reference standard program through tracking of standard testing data and issuance of CoAs and retest memos.
• Serve as CMC team member and project contact with internal and external entities including quality assurance and regulatory.
• Maintain up-to-date knowledge of government regulations and Venatorx policies and procedures.
• Other projects and duties as required/assigned.

Qualifications

Candidate requirements:

• PhD (or BS/MS with experience) individual contributor position with extensive experience in quality control operations. (PhD with 6 , MA with 8, and BA with 10) years of experience in analytical chemistry or related life sciences discipline. Work experience should include a combination of data management and quality control experience in pharmaceutical product development
• Hands-on experience and/or familiarity with HPLC/UPLC, GC, KF, spectroscopy (UV, FTIR, etc.), dissolution and other common analytical techniques used for small molecule drug substance and solid oral dosage drug product testing.
• Advanced working knowledge of cGMP compliance requirements for pharmaceutical analytical development and quality control laboratories.

Preferred Qualifications:

• CDMO management employing cross-functional collaboration skills.
• Small molecule pharmaceutical development for solid oral dosage forms and parenteral
• Experience in a virtual (100% outsourced)development business model is preferred

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