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Adecco US, Inc. Project Manager II Scientific in Cambridge, Massachusetts

Adecco Medical & Science is hiring a Project Manager II for our Pharmaceutical partner Cambridge, MA.

The anticipated hourly wage for this position is between $66 and $67.54. Hourly wage may depend upon experience, education, geographic location, and other factors.

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, Daily Pay, and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria

The MSAT Synthetics team is dedicated to supporting CMC Development and Pharmaceutical Technical activities for new R&D compounds, Life Cycle Management Programs (LCM), product territory extensions, and industrial technical projects. Our team plays a critical role in coordinating multiple technical aspects of MSAT and Manufacturing and Supply (M&S) Programs through organization and alignment with other group divisions including Commercial Global Business Units, R&D, Regulatory, and Alliance Management. We collaborate closely with various internal support laboratories and external contract organization facilities. Our focus includes development activities supporting the small molecule portfolio, encompassing drug substance process development and pharmaceutical development for oral dosage forms such as tablets and suspensions. As products approach the registration and launch stage, we work closely with M&S Sites, Supply Chain, CMOs (through External Manufacturing), and Alliance Partners to outline comprehensive plans and activities.

2.2 Main Accountabilities

A. CMO/CRO Management

  • Prepare summaries of proposals, reports and data from CMOs/CROs for projects and present to management for review

  • Obtain and organize necessary technical information to support projects at internal sites or CMO/CROs

  • Provide technical support to manufacturing sites for significant deviations and drive process and product life cycle management improvements for process robustness and yields

  • • Assist with reviewing contracts (CDSs, MSAs, Quality Agreements) and quotations to support CMC development projects, industrial technical projects and internal industrial development programs

B. Technical Management

  • Execute 2nd generation program technical strategies to the MSAT Technical Product Team, focused on synthetic process development and/or pharmaceutical development of oral dosage forms for small molecules

  • Implement product control strategies in compliance with overall regulatory/quality requirements

  • Select appropriate QbD strategies, process parameter risk assessments, and application of prior knowledge

  • Conduct risk assessments for project activities and outline contingency plans

  • Draft product- and process-specific technical reports to support life-cycle management activities

  • Support MSAT Program Directors and CMC Leaders with planning, coordinating and following activities for the various types of projects

  • Assist with reviewing and finalizing technical documents such as protocols, reports and regulatory dossier content

C. Project Management

  • Organize meetings and prepare project updates for project teams and M&S management

  • Create and maintain detailed timelines and project plans with input from Program Directors / CMC Leaders

  • Organize meetings with project teams for status updates and action items follow-up to ensure adherence to timelines

  • Organize meetings with sponsors (R&D, GBU, M&S Teams) to communicate project updates

  • • Create and maintain detailed project plans with gating / milestones

Section 4: Required Skills & Qualifications

4.1 Education & Experience

  • BS/MS in Chemistry or PhD (preferred), Pharmacy or Life Sciences required;

  • Minimum 7 years of experience in technical project management, pharmaceutical development, technical operations and/or manufacturing of small molecules and/or of drug product dosage forms for small molecules

  • Demonstrated experience as a technical project manager with ability to facilitate multi-disciplinary teams

  • Experience with international project teams is a plus

  • • Quality and/or Regulatory background highly desirable

4.2 Other Skills

  • Proficiency in MS Office (Word, Excel, PowerPoint, Project)

  • Solid writing and presentation skills

Excellent organizational and communication skills

Pay Details: $66.00 to $67.54 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

  • The California Fair Chance Act

  • Los Angeles City Fair Chance Ordinance

  • Los Angeles County Fair Chance Ordinance for Employers

  • San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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