Project Manager - Pharma - CMC
Located in Bend, OR
Salary: Excellent comp & benefits!
A growing biopharma is seeking an experienced Project Manager/CMC Specialist to join their high-performing team!
Where You Get to Live!
Bend, Oregon is the mountain town that has it all! Located in the in the shadows of the Cascade Mountains and surrounded by numerous lakes and rivers, Central Oregon is an outdoor enthusiast’s paradise. Check out the sights and sounds of Bend at: https://vimeo.com/200038114
What You Get to Do!
The Project Manager will play a pivotal role in daily execution of Pharmaceutical Drug Development and GMP Manufacturing activities supporting advancement of the product pipeline. CMC refers to hand in hand with functional leaders and experts, the CMC Coordinator will establish and maintain the pivotal systems and tools necessary for robust on-time completion of critical CMC program activities to include project management, vendor management, financial management, GMP and Development documentation management, and Manufacturing systems and procedures establishment within a cGMP regulated environment.
This position requires excellent communication, collaboration, organization, multi-tasking, planning, documenation and influencing abilities. The position will be directly supporting members of the CMC team whose direction will support daily work assignment and execution methodology.
- Provide CMC project management supporting early to late phase pharmaceutical program advancement.
- Oversee Documentation Management for Pharmaceutical, Analytical, Formulation and Process Development as well all cGMP activities inconjunction with Quality Assurance Document Control. The position will work daily with the CMC and Quality teams and our external vendors to ensure timely receipt, review, approvals and introduction to our QADC system. Leads the CMC technical document management function.
- Supports coordination of day-to-day project planning, meetings, budgeting, tracking, resourcing (external/internal) and execution of CMC activities; Ensures CMC activities are progressing actively toward program goals striving to achieve agreed timelines, milestones, and resource / budget forecasting
- Owns the CMC project financial management system working with the CMC Program Lead and finance department to account for Scopes of Work pricing, purchasing, invoicing and demonstration of earned value
- Directly interfaces with external vendor network supporting the program including Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), Contract Laboratories (CTLs) and consultants
- Coordinates CMC meetings and acts as the Point of Contact (POC) with associated vendor network for project communications (email, memos, reports, data, proposals, scopes of work (SOWs))
- Authors GMP documents to include change controls, deviations, and standard operating procedures; Works daily with Quality Assurance to ensure compliance with cGMP regulations and Quality Systems in concert with Quality Assurance
What You Will Need:
- B.S. degree in chemistry, biology, pharmaceutics, engineering or related scientific field
- A minimum of two years of experience in the pharmaceutical industry with prior experience in a CMC environment
- Excellent communicator both verbal and written
- Proven ability to work independently, proactively; works daily with cross-functional teams and senior management
- Strong collaborative and relationship-building skills
- Ability to effectively prioritize and deliver high-quality results on tight timelines
- Experience and competence with Office365 tools
- Ability to generate gantt charts, spreadsheets and presentations
- A passion for the work you do and the people you do it with!
For confidential consideration, please submit resume to: email@example.com
Express Office: Bend
61379 South Highway 97
Bend, OR 97702