Work Schedule
First Shift (Days)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Summary:
This role will support the Biologics Development and Manufacturing Sciences and Technologies area core functions with the planning, creation and execution of CMC development projects with external parties under the sponsorship of ASO. The position will require extensive interfacing with inter disciplinary scientific staff, Quality, Global Procurement, Finance, Legal and other functional areas. This role provides an excellent opportunity to utilize both a scientific and project management background to contribute to the advancement of our growing and exciting portfolio.
Key Responsbilities:
• Facilitates project progress meetings with CROs, perform issue resolution and escalations and complete project close out activities
• Reviews project needs, estimate funds, and facilitates 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
Education/Experience
• Bachelor's degree in relevant life sciences program field
• AND 6-8 years of relevant experience within the pharmaceutical industry and with a focus in the area of CMC development of Biologics compounds.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Experience in managing CRO/CTOs, primarily in the area of analytical support is preferred.
• Understanding the experience of the drug development process and associated regulatory framework is essential.
• Thorough understanding of cGMP’s is strongly preferred.
• Must be able 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 and results delivery.
• Excellent communication skills
• Proficiency with MS Office (Outlook, Word, Excel, PowerPoint, OneNote) and business systems such as SAP/Ariba are essential.
Working Environment:Below is listed the working environment/requirements for this role:
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.
Compensation and Benefits
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. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
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 our 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
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
