Associate Research Scientist: Biologics

About the Role

This role supports the Biologics Development and Manufacturing Sciences and Technologies area core functions with the planning, creation, and execution of CMC development projects with external parties. The position requires extensive interfacing with interdisciplinary scientific staff, Quality, Global Procurement, Finance, Legal, and other functional areas. It provides an opportunity to utilize both scientific and project management backgrounds to contribute to the advancement of a growing portfolio.

Responsibilities

• Facilitates project progress meetings with CROs, performs issue resolution and escalations, and completes project close-out activities.
• Reviews project needs, estimates funds, and facilitates Statements of Work (SOWs).
• Assists with the maintenance of the outsourced book-of-work database for select strategic partners.
• Ensures that CROs follow applicable SOPs and Quality Agreements.
• Ensures compliance with and maintains required training in relevant BMS and departmental GMP, GLP, SOP, safety, and other guidelines.
• Maintains joint BMS and CRO SharePoint sites.

Requirements

• Bachelor's degree in a relevant life sciences field AND 6-8 years of relevant experience within the pharmaceutical industry, with a focus on CMC development of Biologics compounds. In some cases, an equivalency of appropriate education, training, and/or directly related experience may be considered.
• Experience in managing CRO/CTOs, primarily in analytical support, is preferred.
• Understanding of the drug development process and associated regulatory framework is essential.
• Thorough understanding of cGMPs is strongly preferred.
• Ability to work across and influence multi-departmental initiatives, work independently, and with minimal supervision.
• Working knowledge of project management skills such as facilitation, planning, financial analysis, budgeting, change management, stakeholder alignment, and communication planning.
• Excellent communication skills.
• Proficiency with MS Office (Outlook, Word, Excel, PowerPoint, OneNote) and business systems such as SAP/Ariba.

Working Environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• Adherence to all Good Manufacturing Practices (GMP) and safety standards.

Schedule

First Shift (Days)

Pay

The salary range for this position based in New Jersey is $90,000.00–$110,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
• Retirement and savings programs, such as a competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.