Associate Stability Scientist

About the role

Supports stability strategy team by managing stability study inventory via third party storage company, per approved protocols, managing timepoint pull schedules and samples pulls with the testing labs, storage unit maintenance, inventory control, sample destructions, sample pulls and deliveries, inventory management and reconciliation. Assists with review of stability data and trends. Supports identifying stability annual requirements from the manufacturing site via stability annual requirement documents and enrollment document. Supports stability program activity execution for the current and new products. Engage with generation of sample management program and logistics, master stability protocol, stability study protocol. Review stability study LIMS build for accuracy with respect to sample management. Identify, write, and revise applicable SOPs for managerial review and approval. Write applicable technical reports section for sample storage and sample management pull information for OOS/OOT investigations as needed. Write and revise annual stability requirement documents (PAR/QSR, SAR/YER). Escalate information regarding stability program management that may impact lab capacity, product studies or regulatory commitments directly and promptly to management. Ensure training requirements are met. Works according to cGMP requirements and HA expectations. Supports third party storage facility. Enters test results from contract laboratories into the stability study management systems.

Responsibilities

• Supports stability strategy team by managing stability study inventory via third party storage company, per approved protocols, managing timepoint pull schedules and samples pulls with the testing labs, storage unit maintenance, inventory control, sample destructions, sample pulls and deliveries, inventory management and reconciliation.
• Assists with review of stability data and trends.
• Supports identifying stability annual requirements from the manufacturing site via stability annual requirement documents and enrollment document.
• Supports stability program activity execution for the current and new products.
• Engage with generation of sample management program and logistics, master stability protocol, stability study protocol.
• Review stability study LIMS build for accuracy with respect to sample management.
• Identify, write, and revise applicable SOPs for managerial review and approval.
• Write applicable technical reports section for sample storage and sample management pull information for OOS/OOT investigations as needed.
• Write and revise annual stability requirement documents (PAR/QSR, SAR/YER).
• Escalate information regarding stability program management that may impact lab capacity, product studies or regulatory commitments directly and promptly to management.
• Ensure training requirements are met.
• Works according to cGMP requirements and HA expectations.
• Supports third party storage facility.
• Enters test results from contract laboratories into the stability study management systems.

Requirements

Experience with stability programs desired. Solid understanding and knowledge of cGMPs and regulatory principles. Excellent verbal, written, and interpersonal communication skills are essential. Able to work independently and as part of a team-based environment. Proficient computer software application skills. Demonstrated ability for accurate recordkeeping, thorough documentation, attention to detail, and efficient organization/management of records and time.

Qualifications

Bachelors Degree in Chemistry, Microbiology, or other related scientific discipline.

Skills/Competencies

• Excellent verbal, written, and interpersonal communication skills are essential.
• Able to work independently and as part of a team-based environment.
• Proficient computer software application skills.
• Demonstrated ability for accurate recordkeeping, thorough documentation, attention to detail, and efficient organization/management of records and time.

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life Benefits Include Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.

Pay

$91,180 - $110,488

Schedule

Not specified