**At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.** **Bioprocess Raw Material Chemicals Expert** Lead raw materials projects by providing technical expertise and strategic direction in the sourcing, evaluation, and management of raw materials, including excipients, for clinical and commercial biotech and CGT products through clearly defined project scopes and cross-functional collaboration. **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Bioprocess Raw Material Chemicals Expert, are to: + Oversee and lead change projects for new or modified materials used in biologics or CGT processes, ensuring cGMP compliance while providing technical and scientific support to mission and project teams from development through commercialization of drug substance processes, including manufacturing support for routine commercial manufacturing. + Utilize the cGMP change control process to assess the impact of material changes through risk/GAP assessments and facilitate timely reviews and implementation in partnership with process owners, product teams, project owners and other subclusters as affected. Evaluate and propose changes to raw materials aimed at enhancing overall efficiency, quality, consistency, and regulatory compliance with no or minimal disruption to GMP production. + Develop and implement strategies to monitor performance of existing and new vendors performance from a scientific and technical perspective and collaboration with other functions for ex. QA, procurement and manufacturing. This includes conducting technical audits of vendors to identify adverse trends, risks, or defects that could impact the routine manufacturing of licensed products + Scientific/technical lead to deviations teams on ancillary materials incl. root cause investigations, risk assessments and product impact assessments. + Interact with early development (pre-D4) on raw material qualification. Develop and maintain detailed specifications for raw materials used in the production of licensed products, ensuring they meet quality and regulatory requirements in close collaboration with QC. + Provide leadership in defining and implementing global best practices for raw material management across the biologics portfolio, ensuring consistency, compliance and efficiency. + Actively drive own role with regards to scientific/technical input in teams. Depending on focus of activity this can range from building, leading and motivating team to supporting a team on project deliverables, to building capabilities within the material science space within the cluster. + Foster collaboration with cross-functional teams to ensure effective execution of raw material projects, ensuring that BioDS takes ownership of scientific and technical aspects. **WHO YOU ARE** Bayer seeks an incumbent who possesses the following: **Required Qualifications:** + Bachelor's Degree + Relevant experience in Chemical, Biomedical, Industrial Engineering etc. plus Production and/or Engineering experience in the life science industry and bio pharmaceutical operations or an equivalent combination of education and experience. + Comprehensive understanding of cGMP regulations and requirements for raw materials in production of recombinant proteins and new modality products. Familiarity with chemical standards and regulations such as pharmacopeias and ICH standards. + In-depth knowledge of the GMP change management process in biopharmaceutical operations. + Experience with material and polymer chemistry, process flows, and technologies used in E2E production processes of recombinant proteins and new modalities products. + Strong ability to analyze data, identify risks, and make balanced decisions. + Demonstrated project management skills combined with a strategic ability to clearly define project scope and deliverables, while committing to timelines that consider resource availability. + Excellent written and oral communication, able to engage technical and non-technical audiences, and represent the company to regulatory agencies. + Experience in supporting vendor audits as a technical expert to ensure compliance and quality. + Proactive approach to process optimization and implementation of best practices for enhanced efficiency and quality. + Exhibit strong VACC (Visionary, Architect, Catalyst, Coach) leadership skills while collaborating with diverse cross-functional teams to ensure the timely completion of projects and deliver value to patients and stakeholders + Fluency in English, both written and spoken. Knowledge of German would be an asset. **Preferred Qualifications:** + Bachelors Degree with 10+ or an Master's Degree with 8+, or PhD 5+ years of relevant experience in Chemical, Biomedical, Industrial Engineering etc. plus Production and/or Engineering experience in the life science industry and bio pharmaceutical operations or an equivalent combination of education and experience. Employees can expect to be paid a salary of between $140,000-$188,000. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is merely an estimate and may vary based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors. This posting will be available for application until at least 7/7/2025 **YOUR APPLICATION** Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. 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. Bayer is an E-Verify Employer. **It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.** **Location:** United States : California : Berkeley **Division:** Pharmaceuticals **Reference Code:** 843335 **Contact Us** **Email:** hrop_usa@bayer.com