Senior Manager, CMC QC

Innova Solutions•Brisbane, CA

1d•Hybrid

About The Position

Client is seeking a highly motivated and experienced professional as Manager/Senior Manager for our clinical and commercial programs in the CMC Quality Control Department, 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 review of release and stability data for our CMC QC program(s) including all modalities and small molecules. The Manager/Senior Manager will also provide support to internal QC Leads who work directly with our contract manufacturing organizations (CMOs) and Contract Testing Laboratories (CTLs) to ensure that appropriate quality standards are met for the quality control activities as assigned. The successful candidate will have a good understanding of analytical and biological methodologies, cGMPs, ICH guidelines, Regulatory drug requirements. This is a unique opportunity to join a biotech company focused on developing life transforming therapeutics for patients with rare diseases. This position will be instrumental in supporting the company’s therapeutic products from clinical phase 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 will be expected to carry out other quality control activities in a cGMP regulated environment (ICH, USP and Ph. Eur. Compendial under FDA and EMA).

Requirements

Bachelor’s degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field
5 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)
Working experience and knowledge in a wide variety of quality control analytical and biological methodologies is highly desirable
Experience in conducting stability studies per ICH Guidelines is highly desirable.
Proficiency 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)

Nice To Haves

Familiarity with Veeva QMS for record repository and deviation/CAPA/Change Control will be a plus
Any additional regulatory filing experience will be a plus

Responsibilities

Manage, review, and organize release and stability data from active drug substance/product release, stability programs, and generate interim stability trending assessments and reports
Support the review of the analytical and biological method validations used for QC testing of biologics and small molecule products
Provide internal support to QC operations to support the development, manufacture, and release of Biologics, small molecule, and oligonucleotide products
Implement and maintain quality systems to ensure the integrity and reliability of QC data
Ensure that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies.
Participate in stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. guidelines
Support the external contract organization activities to fulfill the GMP QC testing needs.
Work within QC, with QA, and other departments to address review comments on QC/analytical test documents
Create and update batch analysis tables for stability data
Assist in OOE/OOS/OOT investigations and deviations
Track contract lab stability time point pulls for different programs
Create Excel/JMP tables and charts for stability data trending
Initiate and manage change controls, deviations, investigations, and CAPA in Veeva QMS Document System
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
Manage/assist the document creations and reviews via Veeva Document System