Description

Description: We are looking for an experienced CMC operations manager to join our team as Contract Manager, CMC Operations, managing CMC activities related to the development and manufacturing of clinical pipeline. The ideal candidate should have relevant experience in CMC product development and project management, and enjoy fast-paced, collaborative, and vibrant culture. A team player with a sense of urgency will thrive in this role. This is a 6-month contract role with potential for extension. Responsibilities: Establishes and partners with CMC teams to build project timelines, milestones, risk registers and mitigation plans supporting CMC development and manufacturing activities related to clinical pipelineProactively partners with Process and Analytical Science, Regulatory Affairs, Quality, Manufacturing and Supply Chain teams to ensure alignment of CMC activities with overall project goals.Proactively tracks and ensures CMC milestones are delivered on-time, in-full, and within budget, while ensuring compliance and high quality. Identifying and escalating issues as appropriate through appropriate governance bodies, taking full ownership of the process to drive issue resolution.Builds and fosters high performing CMC teams by setting clear expectations, coaching team members and providing feedback, support and guidance to ensure that each member is enabled to provide their best performance Requirements: Advanced degree (BS/MS or PhD) in Life Sciences preferred, with at least 5-10 years of technical operations experience within the biopharmaceutical industry.Experience managing CMC projects and cross-functional teams responsible for the development and manufacturing of cellular drug products.Industry experience in cell therapy development required.Strong leadership and team management skills, with the ability to influence cross-functional teams.Experience with CMC product development as well as program/project management required.Understanding of CMC development, regulatory CMC requirements, and cGMP compliance.Excellent communication and presentation skills, with the ability to effectively communicate complex technical information to stakeholders.Strong interpersonal, organizational and communication skills. If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com. Pay And Benefits The pay range for this position is $63.00 - $80.00/hr. Eligibility Requirements Apply To Some Benefits And May Depend On Your Job Classification And Length Of Employment. Benefits Are Subject To Change And May Be Subject To Specific Elections, Plan, Or Program Terms. If Eligible, The Benefits Available For This Temporary Role May Include The Following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Waltham,MA. Application Deadline This position is anticipated to close on Feb 28, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, Diversity And Inclusion Are a Bridge Towards The Equity And Success Of Our People. DE&I Are Embedded Into Our Culture Through: Hiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.