Senior Scientist Development
Your tasks and responsibilities
The primary responsibilities of this role, Senior Scientist Development, are to:
- Represent AD in Technical Development Teams (TDT) for new biological development projects for external projects (Gene therapy, Cell-based therapy) including:
- Coordinates with assay subject matter experts (SME), line management and external partner on the method development and validation plans required for the release, stability and extended characterization of the new product
- Collaborates with external partner and TDT to establish the testing schedule, critical quality attributes and specifications for the new product
- Coordinates and manages, with external partner, of the TRD process for regulatory submissions and responses to the agencies.
- Represents AD in TDT for new biological development projects for external partners including:
- Coordinates with assay subject matter experts (SME), line management and external partner (Analytical rep and QA) on the method development and validation plans required for the release, stability and extended characterization of the new product
- Collaborates with TDT and external partner to establish the testing schedule, critical quality attributes and specifications for the new product
- Coordinates and manages the creation of the technical registration documents with the external partner for regulatory submissions and responses to the agencies.
- Manages and coordinates the method transfer activities to external groups (Contract Manufacturing Organization (CMO)) for Bayer projects including:
- Creates transfer plans in collaboration with assay subject matter expert (SME), line management, Quality Assurance Development (QAD) and external CMO.
- Writes/reviews/approves transfer protocols and coordinating the execution between AD and the CMO
- Writes/reviews/approves transfer reports
- Identifies and proposes efficiency projects for the management of AD projects including maintaining and updating the AD Rep Handbook.
- Provides guidance and training to new AD Reps (for
internal Bayer projects) on the AD Rep handbook.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Requires PhD and 12 years of experience in biotechnology industry with 5 years in project management, specifically in the area of Analytical Development, Quality Control with demonstrated experience in GeneTherapy analytics.
- Highly developed project management skills with the ability to translate business/company objectives to relevant project goals and the ability to create detailed work plans with linked dependencies and identified critical path activities.
- Demonstrated ability to manage complex programs cross- functionally.
- Previous experience being on a project team and demonstrated success with significant contributions to major milestones of project by applying a broad range of scientific/technical principles.
- Ability to collaborate with individuals at all levels between various groups and sites and to adapt to changing business environment in a large, global matrixed organization.
- Strong written and verbal communication skills.
- Ability to work independently.
- Good working knowledge of MS Office, Project and/or other relevant software and communication tools.
- Analytical knowledge and/or experience in gene therapy products
- Sound knowledge and experience with cGMP and regulatory compliance (US and other international agencies) for analytics for development/clinical biologics.
- Practical knowledge and sound understanding of pharmaceutical, biologics, drug development process from development to product launch and support of commercial products
- Demonstrated experience in Due Dilligences
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Functional Area: [sap_fa_16]
Entry Level: 5