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Miles
Km80.5

Sr Mgr/Assoc Dir, CMC

Biotie Therapies

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Location: South San Francisco, CA Posted Date: 4/26/2013 Position Type: Full time Job Code: Biotie.CMC.0413 Required Education: Bachelors Degree Areas of Expertise Desired: Manufacturing/Production
Process Development

Description

Collaborate with the VP CMC Operations to ensure Project goals are met, and CMC systems are created, documented, and maintained.

Work with CMC Service Providers to
1)   ensure the quality manufacture of drug substances and products for their intended purposes;,
2)   guarantee scientifically-sound analytical methodologies are developed, documented, and used, and
3)   collect, organize and summarize all technical information obtained.  

Work with Biotie QA, Clinical Operations, Non-Clinical Operations, Regulatory Affairs and Project Management to facilitate Project efforts.  Refine CMC information on decisions, events, status, inventories, etc. for company-wide visibility.

Essential Functions:
Assist in Creating the CMC Portion of Biotie Project Plans
•   Gather the necessary information to enable detailed CMC project planning.
•   For each proposed project plan, prepare budgets, timelines, and identify resource requirements.

Provide Technical Input to the CMC Development of Biotie Products
•   Evaluate upcoming Project materials requirements; prepare Requests for Quotation, and solicit contracts from suitable Service Providers.
•   Participate in the creation and review of Service Provider work agreements, such as Method Development Protocols, Method Transfer Protocols, Method Validation Protocols, Stability Protocols, Formulation and Manufacturing Process Development Protocols.
•   Review and comment on draft Service Provider documents, such as experimental, method, and stability protocols; materials specifications, Master Batch Records, and Master Packaging Records.
•   Gather information on manufacturing deviations and out-of-specification (OOS) results to direct investigations and create appropriate summary documentation.


Establish and Manage the Relationships Between Biotie and its Service Providers
•   Evaluate technical and relevant GXP qualifications of new CMC Service Providers as pertains to project requirements.  Create and maintain Service Provider dossiers.
•   Participate in the creation of contracts and agreements, such as Non-Disclosure Agreements, Master Service Agreements, Contracts for all CMC materials and services, and Technical Quality Agreements.
•   Monitor and document the completion of Service Provider contract milestones with references to specific deliverables.  
•   Assure invoices received meet all contract criteria, and verify all charges.  Route invoices for CMC approval and payment.  
•   Work with the Accounting Department to review accruals for quarterly reports.
•   Prepare agendas for Service Provider meetings, and monitor the execution of Biotie action items.
•   As necessary, travel to meet Biotie Service Providers, including those in other countries.

Organize and Manage all CMC Materials
•   Prepare documentation for all Biotie material shipments.  Oversee shipments to ensure proper packaging, labeling, delivery time, shipping conditions, and availability of recipients.
•   Document the preparation, qualification, and retesting of analytical reference standards.

Prepare CMC Technical Reports and Draft Regulatory Documents. Create and Maintain CMC Documentation Systems
•   Assist in the preparation of new, and updates to Biotie INDs and IMPDs.
•   Assist in the creation, maintenance and internal visibility of all project materials requirements and current inventories (including all the bits and pieces from licensors).
•   Maintain CMC deliverable expectations and timelines, and communicate to Project Management.
•   Assist in the collection, indexing, storage, and control of CMC documents (as distinct from CMC QA documents).  Integrate electronic and paper document systems.  Prepare CMC for possible regulatory inspections.
•   Compile, organize, index, and file all licensor CMC information/documents.  Create general files on available CMC Service Providers and resources.  Create files on worldwide CMC regulatory guidelines and expectations.

Requirements

Preferred Education:  
•   B.S. or higher in physical science discipline.

Preferred Experience:
•   Seven to ten years of experience in GMP pharmaceutical development of small-molecule drug substances and drug products, with three years in a management capacity.  Experience managing external Service Providers.

Preferred Skills and Knowledge:
•   Complete understanding of worldwide regulatory requirements for the preparation and qualification of drug substances and products intended for human use.
•   Word, Excel, Project, ChemDraw, and PowerPoint or equivalent required.

Preferred Special Skills:
•   Knowledge of international shipping procedures and requirements.
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