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                                                 

STC Biologics is a boutique CDMO within the hub of biotechnology in  MA that provides integrated biopharmaceutical CMC services. Our high flexibility combined with technical and regulatory sciences expertise provides unique advantage to clients for bringing their products from preclinical phase to global approvals. 

We are seeking a talented mass spectrometrist. With us, you have the opportunity to learn a diverse range of CMC activities and regulatory sciences while contributing to advancing complex therapeutic products through clinical development.

Key Responsibilities

• Develop and execute detailed analytical plans in an agile manner with minimal re-work.
• Provide routine client updates and deliver high quality work timely. Specific analytical activities include:
  • Develop robust analytical methods for release and stability testing 
  • In close collaboration with Quality, design and execute protocols for phase-appropriate validation of analytical methods, troubleshoot assay performance issues, contribute to addressing Investigations and Deviations  
  • In close collaboration with Process development and Quality, develop in-process and raw materials tests; support in-process testing and contribute to batch records   
  • Biophysical and biochemical characterization of proteins, nanoparticles, and impurities. Characterize structural properties (e.g. glycans, sequence variants, charge variants) and impurity profile using orthogonal and high resolution analytical technologies
• Support writing proposals with swift response to client. Then drive efficient execution of diverse projects that necessitates working with manager to maneuver resources in a matrixed and fast paced environment 
• Track budgeted activities and communicate timely project invoicing per STC procedures          
• Write/review technical reports and documents 
• Train and mentor technical staff
• Be current on analytical technologies, publications, instrumentation, providing recommendations to management.

Credentials and Experience

• PhD degree in protein analytical sciences or related field with 5 years of industry experience in a regulated biopharmaceutical environment.
• Specific expertise in mass spectrometry modalities, intact mass analysis, peptide map/MS/MS, disulfide linkage analysis, glycosylation characterization; hands-on experience with Thermo’s QE mass spectrometer highly desirable.       
• Demonstrated experience with the development of a broad range of analytical methodologies for characterization of biotherapeutics. Experience with biophysical methods, and analysis of complex mixtures and nanoparticles highly desirable
• Knowledge of GMP requirements and ICH guidelines desirable

Competencies

• Drive and flexibility to meet objectives efficiently in a fast pace environment 
• Critical thinking and creativity to integrate information and devise solutions for complex technical problems
• Excellent written and oral communication skills with clear writing of technical reports, client updates, and regulatory submissions
• Effective teamwork, people management through influence and accountability

Internships

STC Biologics, Inc. offers a variety of internship opportunities. Interns at STC go through a rigorous program in developing skills in all areas of drug development from discovery to process and analytical development. Thus far we have trained students from various universities from Massachusetts including Boston University, University of Massachusetts & Babson College. We seek eager young scientists who are smart, driven and able to multi-task. At STC, we believe in mentoring young scientists to become proficient professionals in the industry and acquiring the necessary personal and professional skills for a successful career.