A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
- Capable of leading a diverse team of senior scientists and engineers responsible for technical floor support of ongoing manufacturing.
- Responsible for managing a team dedicated to the management and analysis of critical manufacturing data and process modeling.
- Provide guidance and leadership in the diagnosis and resolution of complex production problems.
- Lead a team of Tech transfer and Validation specialists responsible for effective transfer of processes and technology from the Process Development group into a cGMP Manufacturing environment.
- Maintain a high level of scientific and technical knowledge of biologics/API manufacturing and direct a lab-based group of scientists capable of performing scale-down models of cell culture and purification processes with their associated analytical methods to support on-going process investigations, changes, validation, and process improvement initiatives.
- Develop and/or test the feasibility of new manufacturing technologies and their introduction into a cGMP environment.
- Interface with Manufacturing, Quality, Regulatory and Process Development to facilitate efficient technology transfer of new production processes and change control.
- Strategic advancement, Champion harmonization and alignment across the MilliporeSigma API cluster as well as support expansion projects.
- Provide project management oversight to ensure effective resource utilization, planning, and execution of projects that are in alignment with Site objectives.
- Responsible for ensuring top performance management by personnel in the MSAT organization in delivering high quality work to meet the demands of the site.
- Recruit, direct, coach and develop talent in the MSAT organization to maintain a high level of technical expertise that works collaboratively with key partners.
- Develop risk-based strategies for CMO technical oversight accounting for product life cycle, technical complexity and site capabilities.
- Influence and implement initiatives to meet the MilliporeSigma CMO technical operations vision and mission.
- Lead budget planning process including capital equipment and material needs, staffing requirements, and contracted services requirements.
- Provide technical leadership to support regulatory health authority questions for site operations, scope includes but not limited to initial licensure, post approval changes and routine agency inspections.
- Provide thought leadership for future continuous improvement projects improving current operations capabilities, capacity and efficiency.
Who You Are:
- 10 years of experience preferred, developing and/or supporting commercial scale cGMP manufacturing of pharmaceutical applications/APIs
- Has a strong working knowledge of the Quality and Regulatory aspects of cGMP production.
- Experience in cGMP production in high potent compounds/containment strongly preferred.
- Master’s degree (PHD preferred) in chemical engineering or related Life Science discipline.
- Exceptional communication skills required, with an ability to interact with and influence individuals and teams at all levels across the organization and global network.
- Experience leading transformational change, extreme collaborator and change champion.
- Experience collaborating effectively with other functional groups to achieve business objectives.
- Demonstrated ability to hire coach and develop technical talent.
- Experience in product processes, life cycle management including pre- approval, launch and post approval.
- Experience with Quality Management system including CAPAs, Change and Deviation management.
- Focus on results through leadership contributing to the site leadership team and other projects as specified.
- Demonstrated experience and solid understanding of tech transfer, process validation and comparability in high potent manufacturing.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.