FSP Associate Research Scientist: QC Strategy & Analytical Sciences

About the role

This role supports the Quality Control Strategy & Analytical Science (QCSAS) functions with the planning, creation, and execution of commercial projects with Contract Testing Labs (CTL) under the sponsorship of QCSAS. The position interfaces extensively with interdisciplinary scientific staff, Quality/Compliance, Global Procurement (GP), and other functional areas. This role provides an opportunity to utilize both scientific and project management skills to contribute to the advancement of our growing pipeline and exciting portfolio.

Responsibilities

• Manage overall external project activities, including drafting the Scope of Work (SOW) document, facilitating and/or leading project progress meetings with CTLs, follow-ups, alliance management, issue resolution/escalations, and complete project close-out activities.
• Establish and implement the Single Point of Contact (SPOC) model with strategic and other partner CTLs.
• Plan, forecast, coordinate project work, lead initiatives, assist with gathering pricing information, contracting, metrics tracking, and smooth execution.
• Ensure CTLs follow applicable processes, SOPs, and Quality Agreements.
• Liaise between technical teams, compliance, and CTLs.
• Review project needs, estimate resources, budget, and facilitate the need for external work.
• Make recommendations to move external work to internally supported work streams or other analytical collaborators.
• Drive changes to bring efficiencies and streamline processes.
• Ensure compliance with and maintain required training in relevant and departmental SOPs, GMPs, safety, and other guidelines.

Requirements

• Bachelor’s degree in a relevant life sciences field.
• 6–8 years of relevant experience within the pharmaceutical industry, with hands-on experience in analytical chemistry focusing on CMC development and/or commercialization of novel drug candidates.
• Experience in working with or managing CTLs, primarily in analytical support, is preferred.
• Thorough understanding of cGMPs is strongly preferred.
• Strong understanding of the drug development process and associated regulatory framework.
• Ability to work with CTLs and influence multi-departmental initiatives, work independently, and with minimal supervision.
• Effective communicator (oral and written) with strong follow-up skills and experience working with multiple stakeholders.
• Excellent project management skills, including facilitation, planning, managing, budgeting, and execution.
• Strong collaborator able to work effectively in a team with multiple stakeholders.
• Proficiency with MS Office Suite (Outlook, Word, Excel, PowerPoint, OneNote).

Environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible 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.

Pay

The salary range estimated 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.