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Company | Bayer |
Address | Myerstown, PA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Chemical Manufacturing,Biotechnology Research,Pharmaceutical Manufacturing |
Expires | 2023-08-22 |
Posted at | 9 months ago |
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.
- The incumbent uses the knowledge of Bayer’s global directives and industry standards to develop programs that ensure the sites continued compliance with the relevant regulatory agency requirements
- Oversee development of tech transfer, scale up and validation plans for noted pharmaceutical technologies with focus on technical due diligence and risk assessment.
- This position provides technical leadership and/or support for other initiatives at the site as needed.
- Lead the group in the management and governance of validation plans related to process, cleaning, and continued (ongoing) validation and qualifications.
- Authoring and maintenance of relevant SOPs and ensuring compliance.
- Work results have a broad impact on the Consumer Health organization.
- Identify and implement opportunities of continuous improvement.
- Interacts with FDA when onsite for audit as a subject matter expert.
- Lead evaluation and implementation of material, equipment and process technology innovation in collaboration with internal and external innovation partners.
- End to end technical lifecycle management of products and driving accountability for deliverables with the team.
- Assignments are in complex problem areas targeted to the achievement of broad group or division objectives.
- Lead and develop a team of scientists for product and process development and optimizing activities related to dietary supplements and OTC products, key technology focus being solid and liquid dose formulation, controlled release, direct compression, wet granulation, film coatings, roller compaction etc. and emerging technologies in this space.
- Excellent organizational, interpersonal, management, communication, and decision making skills.
- A track record which demonstrates the skills needed to lead, manage, coach, and develop employees and teams.
- Demonstrated ability to explain and recommend to all levels of personnel the results of projects.
- An excellent understanding of the unit operations associated with the manufacture of solid and liquid pharmaceutical dosage forms.
- Bachelor’s degree in a relevant scientific discipline (Pharmacy, Chemical Engineering or Chemistry preferred)
- Builds effective teams, cultivates innovation, learning and change agility, customer focus, action oriented/drives results, collaborates globally and locally, plans and aligns, drives stakeholder engagement.
- Supervisory experience in managing experienced technical staff required.
- Demonstrated competencies: problem solving, practical judgment, initiative/assertiveness, job knowledge, leadership, planning/organizing, attention to detail, sense of urgency/timing, creativity/innovation, and strong written and verbal communication skills.
- The flexibility to work in a team-oriented or independent environment depending on project needs.
- In depth knowledge of statistical process control and design of experiments
- Demonstrated ability to understand the scientific aspects of company's activities and apply that knowledge to the company's goals.
- Prior experience with continuous manufacturing, continuous coating and PAT preferred.
- In depth knowledge of industry process and cleaning validation requirements.
- Or a Ph.D. in a relevant scientific discipline with 4+ years of experience noted above preferred.
- 10 + years of manufacturing or product development experience preferred or Master’s degree in a relevant scientific discipline with 8+ years of proven experience noted above preferred;
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