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.
The Tech Ops Technical Project Manager primary responsibility is to manage customer specific projects from a technical perspective to deliver a complex integrated solution to the customer. The Project Manager will serve as the liaison between Project Management and Technical Operations for commercial programs. The Technical Project Manager will be aware of project issues and drive solutions to completion. The Project Manager will work with the project team to maintain process data and assist with Deviations, CAPAs and Change Controls, as appropriate. The Project Manager must possess a thorough understanding of API synthesis, manufacturing operations, and the operation of equipment. Project Manager will lead and support the innovative development and execution of technical projects within a team-based environment.
- Responsible for providing project planning, management, and risk mitigation for initiatives and customer programs for MilliporeSigma.
- Monitor performance and serve as a liaison between Project Management and Operations for commercial programs to ensure MilliporeSigma is actively working toward established milestones
- Communicate proactively with all involved personnel to mitigate risks, drive solutions, and improve efficiency.
- Hold regular technical team meetings to determine progress and address any questions or challenges regarding project
- Assist in deviation investigations, CAPA generation and change controls, as necessary
- Proactively review the content of the technology transfer package to prepare for the safe execution of the qualification runs and GMP manufacturing
- Achieve positive laboratory results through a combination of personal hands-on lab experience and managing the efforts of Associate and Assistant Scientists through a matrix relationship with manufacturing
- Exercise good judgement within broadly defined practices and procedures in selecting methods, techniques, and evaluation criteria for obtaining solutions.
- Handle up to 2-3 chemical projects at various states of maturity
- Assist in project quote generation for existing and new business proposals.
- Author, utilize, and train employees on a wide variety of written procedures, including batch records and OP’s
- Work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines
- Adhere to MilliporeSigma’s ethical and behavioral standards as outlined in the employee handbook.
- Become a role model for other Technical Operations and manufacturing employees through superb work habits and excellent occupational behavior
Who You Are:
- Minimum of a BS degree in a scientific field is mandatory; MS or Ph.D. in Chemical Engineering or equivalent is highly preferred.
- Minimum of 5 years "hands on" organic synthesis experience, GMP experience desired.
- Background in cGMP pharmaceutical manufacturing setting, preferably related to API production.
- Knowledge of MilliporeSigma capabilities and understanding of various divisions, departments, cGMP and/or other relevant quality systems with strong evidence of collaborating in a matrix environment
- Broad hands-on knowledge of Organic Chemical synthesis and associated analytical techniques, including areas of medicinal chemistry and API chemical process development and scale-up
- Knowledge and understanding of cGMP other relevant quality systems
- Scientific problem-solving skills, i.e. ability to identify crucial issues in experimental work and suggest possible solutions
- 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.
- Possess highly developed interpersonal, written and verbal skills, including the ability to give presentations and to speak to large groups.
- Demonstrate superior organizational skills and the ability to multi-task proficiently
- Must work well in a team environment, and be an effective leader of a multi-department project team
- High level of creativity and innovation, driven to succeed, as well as lead without authority.
- Experience in cGMP production in high potent compounds/containment strongly preferred
- Demonstrated experience and solid understanding of tech transfer, process validation and comparability in high potent manufacturing.
- Must be able to establish rapport with non-technical parts of the company
- Must be proficient at use of standard office computers as well as software for laboratory work (data capture, data analysis, plotting etc). Specifically, Word, PowerPoint, Excel, MS Project.
- Successful completion of advanced organic chemistry is preferred but relevant experience can be substituted.
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.