Senior Scientist CMC Project Management

We are a boutique CDMO in Massachusetts that provides full CMC services for biologics, applying technical and regulatory sciences expertise to bring products from preclinical phase to global approvals. Established in 2009, we are a highly flexible organization with a creative team passionate about product development that becomes an extension of client’s team. 

We are seeking a driven, highly organized Senior Scientist that is technically strong in biologics product development to develop CMC project plan in collaboration with internal team and client, and to ensure delivering project objectives on target. 

Key Responsibilities

• Partner with STC’s management team and client to write proposals and develop detailed CMC project plans, including scope, materials, timelines, resource needs, and budget. 
• Organize the internal team to map processes and execute on the plan with clear responsibilities. 
• Identify risks and facilitate bringing resolution to obstacles. Identify opportunities and solutions.
• Implement appropriate project change control with clear understanding of impact on quality, resources, timelines and budget
• Manage project team meetings to track progress and arrive at decisions.  Document meeting minutes with clear action items.

Qualification: 

• PhD or Masters with at least 5 years of industry experience within cross functional teams responsible for biotechnology product development. 
• Understanding of cross-functional inputs and interdependencies for drug development.
• Knowledge of biologics CMC regulations and cGMP requirements.
• Proven ability to interpret scientific data and technical writing
• Proficient in Microsoft Excel, Word, MS Project or other project management tools 

Competencies:

• Superb written and oral communication skills
• Time management and project management skills with sense of urgency
• Collaborative, influencer, facilitator, enthusiastic