Manager/Senior Manager, CMC Quality Control

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Job description

Innova Solutions has a client that is immediately hiring for a Manager/Senior Manager, CMC Quality Control.

Position type: Full-time - Contract

Duration: 5 Months

Location: Brisbane, CA

As a Manager/Senior Manager, CMC Quality Control, you will:

Description

This is a hybrid role requiring 1 day onsite in Brisbane, CA and the remaining work hours remote (20 hours per week).

Position Summary:

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, 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 review of release and stability data for our CMC QC program(s) including all modalities and 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, and be a self-starter with the ability to work under limited supervision. 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).

Responsibilities include, but are 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

• QC Data Review:Manage, review, and organize release and stability data from active drug substance/product release, stability programs, and generate interim stability trending assessments and reports
• Method Development and Validation:Support the review of the analytical and biological method validations used for QC testing of biologics and small molecule products
• Quality Control Operational support:Provide internal support to QC operations to support the development, manufacture, and release of Biologics, small molecule, and oligonucleotide products.
• Quality Systems:Implement and maintain quality systems to ensure the integrity and reliability of QC data.
• Regulatory Compliance:Ensure that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies.
• Stability Program management:Participate in stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. guidelines
• External Contract Organization management:Support the external contract organization activities to fulfill the GMP QC testing needs.

Other responsibilities may include:

• 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

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 analytical and biological 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)

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!

Pradip Joshi

Email -

Phone:


PAY RANGE AND BENEFITS:

Pay Range : $70 - $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:

• Named One of America's Best Employers for New Grads by Forbes (2024
• Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, )
• One of the Largest IT Staffing Firms in the US - Ranked by Staffing Industry Analysts (SIA, 2024)
• One of the Largest Staffing Firms in the US - Ranked by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
• Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
• One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
• AWS Advanced Tier Services Partner with 100+ certifications

Website:

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 or
. 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. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.

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