Innova Solutions is immediately hiring for a Sr Manager CMC QC Writer and Reviewer
Position type: 12+ Month contract position
Location: Brisbane, CA
Pay Range: $65/hr - $75/hr
Our client is seeking a highly motivated and experienced professional as Manager/Senior Manager for 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 all aspects of QC data review for commercial and clinical programs, including all modalities, and all molecules. The Manager/Senior Manager will work with contract manufacturing organizations (CMOs) and Contract Laboratories (CLs) to ensure that appropriate quality standards are met to support the programs. This position will collaborate closely with cross-functional departments to achieve corporate goals and objectives. The successful candidate will have a good understanding of cGMPs, ICH 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 bringing the company's therapeutic products from early-discovery development stage to commercial launch and be a critical part of creating an innovation team for the development of the company's next generation products. The individual in this role will be the analytical, technical, and quality operational subject matter expert (SME) for QC CMC writing, review and assist in Regulatory filings (ICH/Compendial/FDA and EMA). Responsibilities include, but not limited to:
Main Focus: The CMC QC Manager/Senior Manager will author, draft. Review, and approve the Regulatory QC CMC sections of our IND/IMPD and BLA/NDA filings for one or more programs
Author, update, and revise CMC stability sections in support of regulatory filings
Address CMC stability inquiries per regulatory inquiries
Perform review/draft of analytical release and stability data, data integrity, laboratory documentation, stability reports, specifications, specification setting reports, and other QC/analytical documents
Other responsibilities may include: Participate in the qualification/validation of analytical test methods for all Product Quality parameters, specification setting, stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. Guidelines
Generate QC documents including, but not limited to, CoAs, reference standard qualifications and reports and risk assessments
Work within QC and with QA and other departments to address review comments on regulatory and QC/analytical documents
Manage/assist the document creations and reviews via Veeva Document System
Create and update batch analysis tables for release data
Create Excel/JMP tables and graphs/charts for release and stability data trending
Initiate and manage change controls, deviations and CAPA with Veeva Document System
Assist in closing Quality events/Deviations (OOS/OOT/OOE) and Deviation investigations
Ensure compliance with current GMP's in a manufacturing environment such that the products are assessed to agree upon specifications in a timely manner in order to support lot release and stability testing
Evaluate existing analytical method validation packages for accuracy and compliance with current ICH/FDA guidelines
Requirements:
Bachelor's degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field
Experience with writing and reviewing of CMC filings for regulatory submissions, including IND/IMPD, BLA, and/or MAA, is highly desirable.
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 release and stability methodologies 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)
Candidates must have good communication skills and great attention to detail. Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you!
Jeff.shay@innovasolutions.com
PAY RANGE AND BENEFITS:
Pay Range*: $65/hr - $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. Recent Recognitions:
One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
ClearlyRated® Client Diamond Award Winner (2020)
One of the Largest Certified MBE Companies in the NMSDC Network (2022)
Advanced Tier Services partner with AWS and Gold with MS
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. § 1324b.
