Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

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:

 

Required Qualifications:

 

  • 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.

 

Preferred Qualifications:

  • 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.

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

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.

 

Country: United States
Location: CA-Berkeley
Functional Area: [sap_fa_1]
Entry Level: 5