Senior Scientist, Analytical RD

Our Senior Scientist, Analytical R&D, plays a vital role within our organization. Once you complete our training, your responsibilities will include managing cGMP analytical method development, validation, and transfer of methods to QC, method improvement, impurity method development and identification of impurities and general batch testing and release. At Quva, this role will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

What the Senior Scientist, Analytical R&D Does Each Day:

• Develops and transfers critical analytical methods from AR&D to QC
• Improves existing QC methods to support QC efficiency
• Analyzes batches for impurities and identify key impurities
• Runs stability tests and programs on commercial batches
• Ensures project deadlines are met and projects are handled in a professional manner
• Ensures all proper policies and procedures/work instructions are followed correctly
• Ensures all duties and processes are in adherence with ISO standards, USP, and cGMP practices and ICH and FDA guidelines
• Writes, maintains and improves standard operating procedures related to analytical methods
• Practices good documentation practices
• Tests and releases commercial batches in support of QC when needed
• Maintains a clean, safe and efficient analytical laboratory
• Breaks down, sets up and maintains analytical systems, especially HPLC and UPLC systems
• Works with QC staff to transfer analytical methods
• Supervises the work of junior staff
• Works with 3rd party vendors and suppliers

Our Most Successful Senior Scientist, Analytical R&D:

• Has good coordinating abilities, attention to detail with positive communication skills
• Has excellent organizational skills with ability to manage multiple projects
• Is proficient in Microsoft Office
• Has experience working with HPLC and UPLC systems

Minimum Requirements for this Role:

• Ph.D. in analytical chemistry or equivalent or Master's degree with extensive experience
• At least 5 years of experience working in cGMP pharmaceutical laboratory environment
• Expert level in developing, validating, and transferring analytical methods
• Understanding of cGMP, FDA, ICH principles, guidance and regulation
• Experience writing SOPs and critical regulated documents for internal and external business
• Extensive knowledge of HPLC, UPLC, Titration, USP methods, UV-VIS, and other analytical technologies for potency and impurity identification

Any of the Following Will Give You an Edge:

• Experience working with controlled substances
• Experience working with sterile injectable

Benefits of Working at Quva:

• Set, full-time, consistent work schedule
• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 17 paid days off plus 8 paid holidays per year
• Occasional weekend and overtime opportunities with advance notice
• National, industry-leading high growth company with future career advancement opportunities

About Quva:

Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma's multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva's overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.

Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is "at will."