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Manager, Operations Product Leader
Pharmaceutical Product Development (PPD)
Plainville, Massachusetts, United States of America
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
This position will be site based in Plainville, MA and will support our Viral Vector Services (VVS Plainville) business unit of Thermo Fisher Scientific. At VVS Plainville, we deliver process development through commercial supply and offer the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
Discover Impactful Work:
You will be responsible for leading a team of Operations Product Leaders to provide on time operations deliverables for client programs. You will partner with cross functional leaders to implement robust business processes support the successful planning, production, testing, and release of product in a fast-paced production environment.
A Day in the Life:Lead operational / production readiness for late clinical stage and commercial manufacturing of new products ensuring robust implementation of new production capabilities that reliably and sustainably meet and/or exceed operational, quality, and cost targets.
Partner with technical leadership, program management and clients to implement product / process improvements, and acts as manufacturing subject matter expert for assessments for change controls, validation protocols, and document changes.
Build client relationships through face to face interactions while hosting client on site during program runs, development of documentation required, and facilitating investigations.
Proactively identify and raise key risks and issues to manufacturing line and site leadership team. Prioritize and lead ad hoc cross functional teams to develop risk mitigation plans and/or lead complex operational issues.
Drive continuous improvement and operational excellence culture through self-detecting and self -correcting processes and systems and instilling strong ownership and accountability.
Ensure consistent communication with program core teams, support resources and management regarding issue identification and resolution; develop formal communication protocols and tools including progress tracking systems, dashboards, and management reports, and any other product specific information as needed.
Lead operational / production readiness for late clinical stage and commercial manufacturing of new products ensuring robust implementation of new production capabilities that reliably and sustainably meet and/or exceed operational, quality, and cost targets.
Partner with technical leadership, program management and clients to implement product / process improvements, and acts as manufacturing subject matter expert for assessments for change controls, validation protocols, and document changes.
Build client relationships through face to face interactions while hosting client on site during program runs, development of documentation required, and facilitating investigations.
Proactively identify and raise key risks and issues to manufacturing line and site leadership team. Prioritize and lead ad hoc cross functional teams to develop risk mitigation plans and/or lead complex operational issues.
Drive continuous improvement and operational excellence culture through self-detecting and self -correcting processes and systems and instilling strong ownership and accountability.
Ensure consistent communication with program core teams, support resources and management regarding issue identification and resolution; develop formal communication protocols and tools including progress tracking systems, dashboards, and management reports, and any other product specific information as needed.
Keys to Success: Education- Bachelor's degree required.
- Master's degree or higher is preferred.
Experience- 5-7 years of related work experience in a regulated environment, or 3-5 years with a master’s degree required.
- Minimum of 3 years in management /or leadership positions in small and medium technical and/or capital projects.
- Preferred experience working in 2 or more functional areas.
- Minimum of 3 years leading cGMP operations in a fast-paced environment.
- Bachelor's degree required.
- Master's degree or higher is preferred.
Experience- 5-7 years of related work experience in a regulated environment, or 3-5 years with a master’s degree required.
- Minimum of 3 years in management /or leadership positions in small and medium technical and/or capital projects.
- Preferred experience working in 2 or more functional areas.
- Minimum of 3 years leading cGMP operations in a fast-paced environment.
Knowledge, Skills, Abilities
- Strong analytical and problem-solving skills; great attention to detail and excellent decision-making process.
- Proven track record to present ideas persuasively and negotiate effectively.
- Exhibits strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
- Demonstrated ability to manage cross-functional teams and collaborate across the business.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today!http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Job posted: 2024-01-15
