Sr Project Specialist - MSAT Biotech
Your tasks and responsibilities
The primary responsibilities of this role, Sr. Project Specialist - MSAT Biotech, are to:
- Acts as subject matter expert on single-use bioprocess materials in the interactions with vendors, internal stakeholders and regulatory authorities;
- Manage cGMP change control processes with respect to externally or internally originating changes in single-use polymeric materials used in a clinical or licensed biopharmaceutical process;
- Support establishing material specifications, conduct supplier audits, and evaluate supplier change notifications. Act as SME for L&E assessments;
- Identify opportunities for single use material COGs reduction and drive strategic improvement projects;
- Lead/support investigations on single use material related issues/deviations/troubleshooting and interact with internal functions a/o vendors to identify solutions;
- Formulates project plans for the most efficient means to accommodate material changes or evaluations, example, extractables and leachables, in a manner least disruptive to ongoing operations;
- Manages expectations regarding changes to ensure efficient decision-making. Manages project timelines and drives implementation to meet business needs;
- Builds expertise and insight into evolving regulatory expectations and industry standards and stays abreast of latest developments;
- Represents Bayer in industry and/or standards-setting fora.
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:
- BS 8+ years of relevant experience OR MS 4+ years of relevant experience OR PhD 2+ years of relevant experience;
- Strong qualitative and quantitative analytical skills;
- Demonstrated project management skills;
- Proven ability to solve complex technical problems
- Advanced scientific writing;
- Ability to negotiate technical positions with internal and external functions;
- Sound business and scientific judgment to support critical decisions;
- Very good written and oral communication as well as strong presentation skills.
- Advanced degree in Polymer Engineering field and proficient in polymer chemistry;
- Familiarity with materials and manufacturers of Biopharmaceutical Single Use Systems (SUS), aging and stability of plastics, root cause investigations, medical devices, SUS robustness and reliability, and a track record of successful problem resolution
- Advanced degree in chemistry, materials science, or chemical engineering with relevant experience in single-use technologies;
- Years of relevant experience ideally includes practical hands-on experience with plastics manufacturing (plastics formulation, molding, or extrusion);
- Experience in troubleshooting/problem solving using polymer material science structure-property relationships including failure analysis is highly desirable.
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_1]
Entry Level: 5