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
Recommended Jobs
Fixed Income Trading Associate
Fixed Income Trading Associate Must have this experience for consideration: ~2–3 years of professional experience in fixed income financing, repo trading, treasury operations, or cash management…
Branch Operations Lead - Brookline Area, MA
Job Description At Chase, we are passionate about creating memorable experiences for our clients and employees, making them feel welcomed, valued, and understood. We build lasting relationships by …
Breast Surgeon
Job Title: Breast Surgeon Location: Boston Medical Center – South Brockton, Massachusetts (with potential clinical coverage in Stoughton or affiliated outpatient sites) Reports To: …
Locum Hematology/Oncology Physician job in Worcester, MA - Make $450/hr - $500/hr
Aya Locums has an immediate opening for a locum Hematology/Oncology job in Worcester, MA paying $450/hour - $500/hour. Job Details: Position: Physician Specialty: Hematology/Oncology Start …
Security Paraprofessional - [Another Course to College] (Temporary Vacancy) (SY25-26)
This position is a temporary vacancy covering for a paraprofessional on leave. The position is expected to end on 06/01/2026 when the current paraprofessional returns to work. At that time, the cover…
Senior software engineer - life sciences - full stack
Job Description Join our software development team of passionate individuals who are making a difference in the Health & Life Science industry to create innovative solutions that improve lives …
Hybrid Board Certified Behavior Analyst
Location: Tewksbury, MA 01876 Date Posted: 01/07/2026 Category: Center Based Education: Master’s Degree Up to $6000 incentive available! We are seeking a BCBA to join our growing and succes…
J.P. Morgan Wealth Management - Private Client Advisor - Sudbury, MA
Job Description At J.P. Morgan Chase, we have an enthusiasm for helping our clients, taking care of our employees, building relationships, and delivering extraordinary customer service while mainta…
Shipping Inventory Clerk
Shipping, Receiving, Inventory Clerk What's In It For Me? Competitive Pay: Expected hourly wage of $22 - $25/hr . Comprehensive Benefits: Access to health insurance and an incentive …
Phlebotomist - Part-Time - In Patient
At Labcorp we have a passion in helping people live happy and healthy lives. Every day we provide vital information that helps our clients and patients understand their health. If you are passionate …