Senior Manager, CMC Quality Control

Senior Manager, CMC Quality Control

Position Summary:

Seeking a highly motivated and experienced professional as Manager/Senior Manager for our clinical and commercial programs in the CMC Quality Control Department, West Coast, US, with the passion and creativity to support development of great medicines for rare and ultra-rare diseases.  The Manager/Senior Manager will be responsible for all CMC QC Program support for the biological programs.  The Manager/Senior Manager also will provide support to internal QC representatives who work with contract manufacturing organizations (CMOs) and Contract Laboratories (CLs) to ensure that appropriate quality and industrial standards are met to support of the quality control activities as assigned.

The successful candidate will have a good understanding of biologics drug substance processes, analytical methodologies, cGMPs, ICH guidelines, and regulatory drug requirements, be a self-starter with the ability to work under limited supervision and have the desire to be part of an innovative team.  This is a unique opportunity to join a biotech company focused on developing life transforming therapeutics for patients with rare and ultra rare diseases.  This position will be instrumental in supporting the company’s therapeutic products from development stage to commercial launch and be a critical part of an innovation team for the development of the company’s next generation products.  The individual in this role is expected to carry out all quality control activities in a strict regulated GMP environment (ICH/USP and Ph. Eur. Compendial/FDA and EMA).

Responsibilities including, but not limited to:

Main focus: The Manager/Senior Manager of CMC QC will work across the Ultragenyx biological products/programs as assigned (Clinical & Commercial products at West Coast US) for quality control operational support:

·        Method Development, Validation, and transfer: Support the development, validation, and transfer of analytical methods used for QC testing of biologics, small molecule and oligonucleotide products.

·        QC data review: Manage, review, and organize Release/stability, method validation/transfer data from active stability programs and generate interim stability trending assessments and reports

·        External Contract Organization management: Support the external contract organization activities to fulfill the GMP QC testing for release/stability and method validation/transfer needs.

·        Quality Control Operational support: Provide internal support to QC operations to support the development, manufacture, method validation/transfer and release/stability activities, of Biologics.

·        Regulatory Compliance: Ensure that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies.

·        Quality Systems: Implement and maintain quality systems to ensure the integrity and reliability of QC data.

·        Stability Program management: Participate in stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. guidelines

·        Other responsibilities may include:

·        Work within QC and with QA and other departments to address review comments on QC/analytical documents

·        Manage/assist the document creations and reviews via Veeva Document System

·        Create and update batch analysis tables for stability data

·        Keep track of contract lab stability time point pulls for different programs

·        Create Excel/JMP tables and graphs for stability data trending

·        Initiate and manage change controls, deviations and CAPA in Veeva Document System

·        Assist in OOE/OOS/OOT investigations and deviations

·        Ensure compliance with current GMP’s in a manufacturing environment such that the products are assessed to agreed upon specifications in a timely manner in order to support release and stability testing

Requirements:

·        Bachelor’s degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field

·        Quality Manager: 3 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)

·        Senior Quality Manager: 5 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)

·        Experience with a good understanding of biologics drug substance processes; encompassing the initial cell culture and production phases (upstream), as well as the subsequent purification and isolation steps to create the final drug substance (downstream).

·        Working experience and knowledge in a wide variety of quality control stability methodologies is highly desirable

·        Experience in conducting stability studies per ICH Guidelines is highly desirable.

·        Good oral and written communication skills and a fast learner

·        Proficient in project and personnel management, excellent organizational skills and the ability to work on multiple projects with tight deadlines

·        Proficiency in MS Office, Word and Excel

·        Proficient in statistical analysis software desired (Excel/JMP)