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SalaryWe have recently partnered with one of our customer's to provide direct hire recruiting services. By applying to this position you understand you are not applying to a direct full-time role within CAI. During the screening process, details surrounding the client's location and benefits will be provided.
The Quality Control Manager has responsibility for actively overseeing cGMP Quality Control activities associated with development and commercialization of the company’s small-molecule assets. The QC Manager is responsible for oversight of Quality Control activities of drug substances, drug products, intermediates, starting materials, excipients, and packaging materials and components. This person will also review and approve protocols, methods, reports, batch records and related GMP source documents, as well as have oversight of stability operations and reference standard programs, and transfer/site implementation of analytical methods to support future supply chain expansion.
This person additionally will have responsibilities to actively manage data and documents by using various software like Excel, istability, Statistical software, and Master Control for commercial projects. The selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
The incumbent will work collaboratively on validation as well as FDA request for information (RIF)
This position will report to the Head of Department and the Director of Quality Assurance, Quality Control and Regulatory Affairs. This is an onsite position.
Job Description:
- Review/approve controlled GMP analytical documents, e.g., analytical methods and associated validation protocols, reports, specifications, change controls, investigations, any relevant environmental monitoring tests.
- Compile data and conduct tracking/trending/statistical analysis of batch release data and stability data.
- Support Root Cause Analysis and product impact assessment for investigations because of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
- Manage the continued expansion of existing and the implementation of new departmental document and data management systems.
- Manage the life-cycle performance of analytical methods from development through commercialization.
- Perform QC review/approval of analytical test data for IPC testing, drug substance/product batch release and stability test data.
- Author and/or review standard operating procedures (SOPs) relating to Quality Control.
- Manage stability activities at CDMOs or Contract testing laboratories (CTL) and compile/analyze stability data/reports using istability and statistical software for IPC or SPC and maintain a reference standard and critical reagent programs.
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment.
Requirements:
- B.S. degree in analytical chemistry or related discipline (an M.S. degree or a Ph.D is preferred)
- 7-10 year of experience including data management and Quality Control experience in pharmaceutical product development and/or commercialization.
- Hands-on experience and/or familiarity with HPLC/UPLC, GC, KF, TOC, 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.
- Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously.
- Ability to work independently with good judgement and strong organizational skills.
- Preferred Qualifications:
- Experience managing cross-functional collaboration teams.
- Experience in developing and commercializing drugs for 503A/B drugs and/or orphan diseases is desirable.
- Small molecule pharmaceutical development and manufacture for injectables or solid oral dosage forms.
About Bespoke Pharmaceuticals
- Bespoke Pharmaceuticals, LLC is a pharmaceutical manufacturer that has recently established a new production facility in Las Vegas, Nevada. The company aims to become a leading developer and manufacturer of pharmaceuticals, with a focus on customer-friendly and cost-efficient packaging and delivery systems.
- Bespoke Pharmaceuticals has commissioned Korber’s Business Area Pharma to support them in designing and constructing their new production facility. Korber is providing Bespoke Pharmaceuticals consulting services in areas of process design, workflow, building layout, software selection, machinery, and auxiliary equipment.
- Bespoke Pharmaceuticals is actively seeking leaders in several key operational roles who are excited to be part of a facility start-up with the potential for professional growth.
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Average salary range, not including benefits (medical, dental, and retirement).
CAI and Bespoke are equal opportunity employers; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our companies. We pledge to operate in a way that is fair and equitable to all – our employees, our customers, and the broader society.
This job description is not all inclusive and you may be asked to do other duties. CAI and Bespoke will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).
