CMC Project Leader - Vista, CA

Bachem AG•Vista, CA

8d•$143,204 - $196,906•Onsite

About The Position

The CMC Project Leader is responsible for coordinating and proactively managing ongoing active pharmaceutical ingredient (API) manufacturing campaigns for Bachem's biotechnology and pharmaceutical clients. This role reports to the Director and serves as a key liaison—externally with customers and internally with cross-functional teams, including Sales, Quality Control (QC), Quality Assurance (QA), Logistics, and Production. The CMC Project Leader ensures that client milestones and deliverables are met efficiently and on schedule.

Requirements

Bachelor's Degree in Science (Chemistry, Biochemistry, Bioengineering or similar field required)
Minimum 6 years' experience of (bio-)pharma/CDMO/chemical industry with bachelor's degree required
Minimum 4 years' experience of (bio-)pharma/CDMO/chemical industry with master's degree required
Minimum 2 years' experience in customer-facing role or CMC project management required
Have basic knowledge of clinical development (phases, key goals, requirements) and associated regulatory compliance/filings for drug substances. Basic understanding of GMP required
Ability to understand financial aspects of customer accounts (Payment terms, pre-payment requirements, forecasting)
Familiarity with drug substance characterization analysis (HPLC, UPLC, LC-MS, MS, GC-MS, AAA, CHN) for in-process, release, and stability testing
Excellent computer/system skills, especially MS Office, CRM (Salesforce), Document Control (Master Control), Document-sharing (SharePoint, ShareFile), ERP (SAP) or CRM, MS Project
Demonstrated ability to effectively organize, multitask, and thrive in a fast-paced, deadline-driven environment. Skilled in proactive, solution-focused communication, ensuring management and stakeholders are informed of potential issues. Detail-oriented with strong problem-solving skills, capable of working independently and managing time efficiently. Excellent communicator with the ability to collaborate effectively in cross-functional team settings.
Knowledge of Chemistry, Manufacturing, and Controls (CMC) documents having to do with IND and NDA filings and API development
Knowledge of contracts and agreements (NDA’s, Supply Agreements, Quality Agreements, Request for Proposals) to ensure they are adhered to during project execution

Nice To Haves

Master's Degree in Science (Chemistry, Biochemistry, Bioengineering, or similar) field referred
Master's Degree MBA, PMP, or similar certification preferred
PhD in Science (Chemistry, Biochemistry, Bioengineering, or similar) field preferred
Experience with different types of customers (small/biotech and large) with a basic understanding of GMP preferred
Certified Project Management Professional (PMP)-PMI preferred

Responsibilities

Leading project teams (3-10 internal and additional external members) for customers and in-house R&D operationally
Acting as business lead in ongoing collaborations: contract negotiation, business proposals and forecasting, risk-sharing options
Accountable for adhering to project scope and reaching deliverables on time by considering associated agreements/contracts with the customer
Go-to person for project-related tasks, questions, and issues (in line with roles and responsibilities as defined in the PM Guide)
Structuring, leading, and monitoring activities together with the project team members by using available tools and systems
Representing Bachem in project-related context towards senior and/or executive leadership of Bachem's customers
Reporting accurate project data in existing tools for Customer Relationship Management (CRM) and document exchange platforms (e.g. Salesforce, Teams)
Business partner to Bachem senior and executive leadership to secure necessary capacity and/or support for customer projects
Compiling accurate and fit-for-purpose documentation (minutes, plans, actions, summaries, strategic options, etc.) by using existing templates
Recognizing opportunities within project operations to expand scope of the existing collaboration and proactively taking those up with the project team for presentation to the customer with the target of generating additional business