Innova Solutions is immediately hiring for a Manager/Senior Manager, CMC Quality Control.
Manager/Senior Manager, CMC Quality Control
This is a hybrid role requiring 2 days onsite in Brisbane, CA and 3 days remote work. Position Summary: Innova is seeking a highly motivated and experienced professional as Manager/Senior Manager for our external stability 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 aspects of the CMC QC program(s) support for commercial and clinical programs, including all modalities and all molecules. The Manager/Senior Manager will provide support to internal QC representors who work with contract manufacturing organizations (CMOs) and Contract Laboratories (CLs) to ensure that appropriate quality standards are met to support of the quality control activities as assigned. The successful candidate will have a good understanding of cGMPs, ICH stability, 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 diseases. This position will be instrumental in supporting the company's therapeutic products from early-discovery development stage to commercial launch and be a critical part of 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 environment (ICH/Compendial/FDA and EMA). Responsibilities including, but not limited to: Main focus: The Manager/Senior Manager of CMC QC will work across all products/programs as assigned (Clinical & Commercial products at West coast US) for quality control operational support
External Contract Organization management: Support the external contract organization activities to fulfill the GMP QC testing needs.
Quality Control Operational support: Provide internal support to QC operations to support the development, manufacture, and release of Biologics, small molecule, and oligonucleotide products.
Regulatory Compliance: Ensure that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies.
Method Development and Validation: Support the development and validation of analytical methods used for QC testing of small molecule and oligonucleotide products.
Quality Systems: Implement and maintain quality systems to ensure the integrity and reliability of QC data.
QC data review: Manage, review, and organize Release/stability data from active stability programs and generate interim stability trending assessments and reports
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)
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)
PAY RANGE AND BENEFITS:
Pay Range*: $65-75/hr *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Website: https://www.innovasolutions.com/
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. ยง 1324b
