19 Apr, 2022
Biochemicals / Pharmaceuticals
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Senior Process Engineer, are to:
- Provide scientific and technical expertise in support of the clinical and commercial manufacturing process;
- Propose and drive implementation of creative solutions for improvements and in solving manufacturing issues, with a focus on downstream process;
- Proactively lead teams of larger scope (or portions of projects) that manage the identification, development and implementation of process improvements related to robustness, cost of goods and/ or technology transfer;
- Independently manage multiple cross-functional projects that require global regulatory submissions;
- Participate in a technical evaluation of a new production site, process, or potential product for feasibility (due diligence);
- Effectively present complex technical information to an audience of varied expertise/level for guidance, education and decision-making;
- Collaborate with key stakeholders including Biologics Development, Validation and Technology Transfer, Cell Culture Technology Center to transfer, provide manufacturing solutions and launch late-stage clinical programs (protein, antibodies, CGT) as well as with commercial manufacturing (specifically API), Quality to maintain and improve marketed product operations;
- Contribute to scientific field of expertise with external presentation and publications.
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:
- Bachelor of Science with at least eight years of relevant experience in Chemical, Biomedical, Industrial Engineering etc., or Master of Science with at least four years of experience or Ph.D. with at least two years of experience with at least Production and/or Engineering experience in the Biopharmaceutical industry or an equivalent combination of education and experience;
- At least three years of working experience with cGMP, FDA regulations and with exposure to documentation systems required of a business in the pharmaceutical industry;
- Development and at-scale implementation of downstream technologies;
- In-depth scientific knowledge and experience in a wide array of purification techniques such as Affinity and Ion-exchange Chromatography, TFF/Viral filtration etc., and ideally familiar with standard downstream equipment, e.g. AKTAs;
- Skilled in planning lab experiments using DoE and basic understanding in performing data analysis using statistics;
- Strong ability to plan and prioritize complex activities;
- Strong analytical skills to identify risks and prepare balanced decisions;
- Ability to troubleshoot and make quick, knowledge and experience guided decisions;
- Good technical writing skills;
- Very good written and oral communication as well as strong presentation skills;
- Excellent people skills, ability to communicate and partner well, to lead and to motivate, and to resolve conflict;
- Show initiative in keeping abreast of literature in field of interest;
- Relocation assistance is available.
- Broad exposure to Biotech manufacturing (including drug product manufacturing);
- At least three years of working experience with the knowledge of the methods and tools of project management and ability to manage timeline.
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.
|IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer active employees are required to disclose their vaccination status and if fully vaccinated, provide proof of vaccination status before participating in approved activities for fully vaccinated employees. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, if candidates are invited on site as visitors for in person interviews, they must provide proof of being vaccinated and comply with all safety protocols.