Sanofi Group Stability Specialist Senior, Framingham, Massachusetts in Framingham, Massachusetts

JOB PURPOSE:

This position is responsible for participating in product release and stability necessary to ensure that complete and accurate data is available for establishing certificate of analysis, storage requirements and period of use dates for nonclinical and clinical products and in-process materials manufactured within Biopharmaceutical Development. Coordinates and maintains product release and stability testing program and develops stability procedures (e.g., SOPs, protocols) in accordance with GLP, GMP, EMEA and ICH regulations and guidelines. This job description reflects management’s assignment of essential functions as depicted below. It does not restrict management’s authority to assign or reassign duties and responsibilities to perform this job at any time.

RESPONSIBILITIES:

Receives and maintains product inventories in accordance with established procedures. Ensure that the product is being maintained under appropriate storage conditions and participates in weeknight and weekend on-call/standby rotation to monitor storage conditions and address issues. Deviations are appropriately documented and acknowledged. Participates with team(s) to appropriately addresses and correct incidents of non-compliance or unusual observations.

Distributes release and stability samples to analytical laboratories for testing according to schedule. This requires transportation of samples around campus as well as preparation of shipments to offsite locations. May require travel to other local sites.

Maintains accurate and complete inventory records for all products received, stored, and distributed by Stability. This includes, but is not necessarily limited to products submitted for release and stability testing, sample retains, or for research use and may include drug substance, formulated bulk, and drug product.

Analyze stability data and prepare stability reports ensuring the accuracy of said reports. Responsible for the circulation to applicable management.

Development and maintenance of applicable standard operation procedures and related systems for congruent management and coordination of stability activities.

Development of stability study protocols and ensures that establishing strategies for new products are executed properly.

Compares new and current global trends to our current processes and identifies potential problem areas.

Represents organization/group as a prime contact on contracts, programs or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations/group.

Recognizes and participates with applicable team(s) to appropriately address and correct deviations from established requirements.

Provides training to less experienced staff.

Accepts additional assignments as required.

Continuously develops and maintains the required technical knowledge and skills to maintain our compliance in a global regulatory environment. This may include participation at both in-house training/discussion groups and management approved offsite venues. Associated travel in this position is generally limited to attendance at off-site training courses and seminars. (5%)

Participates as part of the support team during FDA (i.e., GLP, GMP) and/or other regulatory inspections as needed.

MINIMUM REQUIREMENTS:

Education / Experience:

The incumbent should possess a Bachelor’s degree preferably in the life sciences or science-related field and 6-9 years of relevant experience in a pharmaceutical or comparable regulated industry or Master’s degree and 4-7 years. This person should have an understanding of the GLPs, GMPs and ICH guidance, especially as they pertain to stability requirements. Position requires up to 5% travel (domestic) and affects weekends. Operates independently or under minimal supervision and direction.

Knowledge / Skills:

Required: Excellent written and spoken communication skills, as well as computer proficiency and a general understanding of the same. Good organizational and interpersonal skills, high quality documentation skills and attention to detail. Ability to follow written instruction (SOPs, protocols, schedules). Analytical data interpretation and basic statistical analysis skills.

Supervisory:

Not Applicable

Other:

The following are considered critical to perform the responsibilities of this position:

-Standing for extended periods of time (in some cases up to 3 hours)

-Handling refrigerated materials and exposure to cold temperature (2-8C) for extended periods of time (in some cases up to 3 hours)

  • Handling frozen materials and exposure to cold temperature (minus 20C) for not longer than 15 minutes per task

-Safe handling of ultra-low temperature materials (as low as minus 80C and using dry ice) for not longer than 15 minutes per task

-Lift, bend and move at waist level, above the shoulders and below the knees, carry up to 30lbs for no more than 5 min, or push or pull substantially heavy objects (50-100lbs) onto a hand cart for transport no more than 15 minutes walking distance.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SG

#LI-GZ

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life