Technical Leader, MSAT CMC Development, Boston

Immediate need for a talented Technical Leader, MSAT CMC Development. This is a 11+months contract opportunity with long-term potential and is located in Cambridge, MA (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: (phone number removed)

Pay Range: $50 - $66/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

 

Notes: BS/MS in chemistry, pharmacy or science with strong experience in pharmaceutical development, specifically oral dosage form for small molecules.

We are looking for someone with experience in small molecule pharmaceutical development for oral dosage (tablet, suspension,…).

Specifically, you will be involved in pharmaceutical development activities (small molecules) for oral dosage forms such as tablets or suspensions.

Executes 2nd generation program technical strategies to the MSAT Technical Product Team, focused on pharmaceutical development of oral dosage forms for small molecules

Implements product control strategies

Provides technical support to manufacturing sites for significant deviations and drives process and product life cycle management improvements for process robustness and yields

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

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

Supports MSAT Program Directors and CMC Leaders with planning, coordinating and following activities for the various types of projects outlined above, organizing meetings and preparing project updates for project teams and M&S management.

Specific duties and responsibilities include, but not limited to:

Creating project scope documents to gain sponsor and management approval.

Creating and maintaining detailed timelines and project plans with input from Program Directors / CMC Leaders.

Organizing meetings with project teams for status update and action item follow up to ensure adherence to timelines.

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

Conducting risk assessments for project activities and outlining contingency plans.

Creates and maintains detailed project plans with gating / milestones

Prepares summaries of proposals from CMOs/CROs for projects and presents to management for review.

Obtains the necessary technical information to support projects at internal Client sites or CMO/CROs.

Assists with reviewing and finalizing technical documents such as protocols, reports and regulatory dossier content.

Assists with reviewing contracts (such as CDSs, MSAs, Quality Agreements) and quotations to support CMC development projects, Industrial technical projects and internal Industrial Development programs.

Key Requirements and Technology Experience: 

Key Skills; MSAT/CMC development

small molecule

pharmaceutical development

oral dosage (tablet, suspension,…)

Product life cycle management

Technical Project Management

BS/MS in chemistry, pharmacy or science with strong experience in Pharmaceutical development, specifically oral dosage form for small molecules, technical operations and /or manufacturing. MBA a plus.

Proficiency in MS Office

Knowledge of project management software

Solid writing and presentation skills

Excellent organizational and communication skills.

At least 7+ years’ experience in technical project management, relevant pharmaceutical development, technical operations and/or manufacturing of various drug product dosage forms for small molecules.

Must have prior experience as a project manager of technical projects with demonstrated ability to facilitate multi-disciplined teams.

Experience with international project teams a plus.

Quality and/or Regulatory background also highly desirable.

Knowledge of French language (speak, read and/or write) a plus.

Open to travel up to ~20% of the time

Job based in Cambridge, MA, with on-site presence in compliance with Client policy

Our client is a leading Healthcare Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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