Job Description

Target PR Range: 39-49/hr
*Depending on experience
What you will do
Let’s do this! Let’s change the world! In this vital role, you will provide support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies and GMP data management. In this team-based role, you will directly add to the success of a Product Quality Team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance, Quality Engineering, International Quality and Process Development on projects, issue resolution and investigations.
The Specialist Stability builds and monitors stability studies within quality systems (e.g. LIMS), owns and handles product quality and stability data and may serve as a primary author on regulatory filings and directly participate in and support site-based GMP inspections. Additional responsibilities include business process support, such as SOP authoring and management, or gap assessments to regional regulations. Expertise in project management, time management and successfully navigation skills for matrixed team environments are essential.
Offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we’re employing are not only new to but are new to the industry as a whole. Help us to pave new roads for helping patients.
Key Responsibilities include:
• Build and maintain technical GMP documents and product stability studies
• Review, verify, report, and archive GMP data for clinical and commercial products
• Apply keen attention to detail to conduct data review and reports
• Execute transactions in relevant GMP computer-based systems (change control, LIMS, etc.)
• Adeptly manage time-sensitive activities independently
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is an expert with these qualifications.
Basic Qualifications:
• Doctorate degree OR
• Master’s degree & 3 years of Quality, Operations, Scientific, or Manufacturing experience, OR
• Bachelor’s degree & 5 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Associate’s degree and 10 years of Quality, Operations, Scientific, or Manufacturing experience OR
• High school diploma / GED and 12 years of Quality, Operations, Scientific, or Manufacturing experience
Preferred Qualifications
• Bachelor's degree or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with growing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
• Experience working in a regulated environment (either direct GMP or technical support)
• Previous experience with either synthetic or biologic stability program management (e.g., designing studies, authoring stability study documents, reviewing data monthly and annually, coordinating with Supply Chain/Manufacturing groups to obtain samples, collaboration with Quality Control testing groups, etc.,).
• Strong project management skills
• Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques
• General knowledge of cGMP and US and international filing regulations pertaining to the manufacture and testing of pharmaceuticals and/or bio-pharmaceuticals
• Experience using computer software such as MS Office (i.e., Excel, Word, Project), LIMS, document management systems, regulatory application systems, etc.
• Experience working on a cross-functional team in a matrix environment
• Excellent written and verbal communication skills, including facilitation and presentation skills

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