Senior Manager, Manufacturing Technical Operations
3 weeks ago
Catalent is seeking a Senior Manager, Manufacturing Technical Operations to oversee the daily activities of the MTO group, ensuring quality results and adherence to safety guidelines. The successful candidate will build, lead, and manage the MTO group to support ongoing and future manufacturing operations.
Key Responsibilities- Manage the interface of the MTO group with internal stakeholders and clients through proactive communication and accountability for on-time project/work completion.
- Oversee daily activity for the group to ensure quality results.
- Performance management for direct reports and drives timely completion of major manufacturing investigations and deviations and subsequent CAPAs.
- Oversight and coordination of manufacturing continuous improvement (e.g. CAPAs, Change Controls) and operational excellence activities.
- Establish and manage a yearly slate of improvement projects with measurable results aligned with the site's objectives.
- Masters' degree in a Scientific, Engineering or Biotech field with 5-7 years' experience in cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities – OR -Bachelor's degree in a Scientific, Engineering or Biotech field with 8+ years' experience in cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities.
- Previous management and leadership experience and will promote a positive experience for employees.
- Knowledge of GMP's, FDA regulations and documentation procedures required.
- Experience in quality systems regulations; Previous experience in process deviation investigations and remediation; to include authoring and/or revising technical documents.
- Competitive salary with yearly bonus potential.
- Defined career path and annual performance review and feedback process.
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
- 152 hours of paid time off annually + 8 paid holidays.
- Generous 401K match and Paid Time Off accrual.
- Medical, dental and vision benefits effective day one of employment.
- Tuition Reimbursement.
-
Manufacturing Operations Manager
4 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryCatalent is seeking a highly skilled Manufacturing Manager to lead our purification operations at our Contract Manufacturing Facility. As a key member of our team, you will be responsible for managing and improving the purification operations, ensuring staff are fully trained on cGMP manufacturing operations and documentation, and adhering to...
-
Manufacturing Manager
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryCatalent is seeking a highly skilled Manufacturing Manager to lead our biologics production team. As a key member of our operations team, you will be responsible for managing multiple teams to execute procedures for downstream manufacturing and support area of manufacturing using SOPs and batch records.This is a full-time on-site position,...
-
Manufacturing Supervisor
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob Summary:Catalent Inc is seeking a highly skilled Manufacturing Supervisor to lead our downstream production team. As a key member of our team, you will be responsible for overseeing the execution of manufacturing processes, ensuring quality results, and driving engagement among team members.Key Responsibilities:Supervise manufacturing processes and...
-
Senior Quality Assurance Manager
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryThe Senior Quality Assurance Manager will oversee the Client Support processes and personnel, ensuring staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines. This role will drive engagement and create a culture where employees are motivated to do their best. The successful candidate will...
-
Senior Facilities Engineer
4 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeAbout the RoleThe Senior Facilities Engineer will provide critical engineering support for utilities used in GMP manufacturing. This individual will collaborate with the Facilities and Engineering teams, as well as Manufacturing, to design and scale-out manufacturing capability and support manufacturing operations, while improving existing manufacturing...
-
Senior Facilities Engineer
2 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob Summary:Catalent Inc is seeking a highly skilled Senior Facilities Engineer to provide engineering support of critical utilities used in GMP manufacturing. This role will work closely with the Facilities and Engineering teams, as well as Manufacturing to design and scale-out manufacturing capability and support manufacturing operations, improve existing...
-
Manufacturing Scheduler
4 weeks ago
Harmans, Maryland, United States MSCCN Full timeJob SummaryThe Manufacturing Scheduler will play a critical role in the Supply Chain organization, reporting to the Senior Manager, Production Scheduling. This position will lead the entire manufacturing scheduling process for an assigned production area, serving as the central source of information.Key ResponsibilitiesDevelop, update, and adjust the...
-
Senior Facilities Engineer
4 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob Title: Senior Facilities EngineerCatalent is seeking a highly skilled Senior Facilities Engineer to join our team. As a key member of our Facilities and Engineering team, you will be responsible for providing engineering support of critical utilities used in GMP manufacturing.Key Responsibilities:Lead the design, implementation, and commissioning of new...
-
Senior Quality Assurance Manager
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryThe Senior Quality Assurance Manager will oversee the Client Support processes and personnel, ensuring staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines. This role will build effective teams that apply their diverse skills and perspectives to achieve common goals, drive engagement, and...
-
Senior Facilities Engineer
4 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob Title: Senior Facilities EngineerCatalent Inc is seeking a highly skilled Senior Facilities Engineer to join our team. As a key member of our Facilities and Engineering team, you will be responsible for providing engineering support of critical utilities used in GMP manufacturing.Key Responsibilities:Lead the design, implementation, and commissioning for...
-
Senior Quality Assurance Manager
2 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeCatalent is a global leader in the development and manufacturing of new treatments for patients worldwide. We are seeking a highly skilled Senior Quality Assurance Manager to join our team.The successful candidate will be responsible for providing support and oversight to the Quality Control Team as they support the Quality Control and Batch Disposition...
-
Senior Scientist QC Compliance Specialist
4 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob Title: Senior Scientist QC ComplianceThe **Sr. QC Scientist - Compliance** role is critical to our patients' safety and well-being. This position is responsible for supporting compliance in the Quality Control Laboratory, including authoring, management, and/or tracking of investigations/events/deviations, Corrective Action / Preventive Action (CAPA),...
-
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryAs a Senior Manager, Supply Chain Analytics and Improvement, you will lead a team of analysts to establish, maintain, and analyze divisional data to model alternatives proposing best outcomes within initiatives and supply practices.Key ResponsibilitiesAnalyze data extracts from varied systems and databases within current and future scaled business...
-
Senior Facilities Engineer
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeAbout the RoleThe Sr. Facilities Engineer will provide critical engineering support for GMP manufacturing utilities. This individual will collaborate with the Facilities and Engineering teams, as well as Manufacturing, to design and scale-out manufacturing capability and support manufacturing operations. Key responsibilities include leading the design,...
-
Harmans, Maryland, United States Catalent Full timeAbout the RoleThe Senior Manager, Supply Chain Analytics and Improvement, will lead a team of analysts to establish, maintain, and analyze divisional data to model alternatives proposing best outcomes within initiatives and supply practices.Key ResponsibilitiesAnalyze current outcomes to clearly understand opportunities for improvement across the supply side...
-
Quality Systems Audit Manager
4 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob Title: Manager, Quality Systems AuditCatalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. We are seeking a highly skilled and experienced Manager, Quality Systems Audit to join our team.Job Summary:The Manager, Quality Systems...
-
Senior Validation Engineer
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeAbout the RoleCatalent is a global leader in the development and manufacturing of new treatments for patients worldwide. We are seeking a highly skilled Senior Engineer, Computer System Validation to join our team in Harmans, MD.Job SummaryThe Senior Engineer, Computer System Validation will be responsible for participating in validation projects related to...
-
Quality Systems Audit Manager
4 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob Title: Quality Systems Audit ManagerCatalent is a global leader in the development and manufacturing of new treatments for patients worldwide. We are seeking a highly skilled Quality Systems Audit Manager to join our team.Job Summary:The Quality Systems Audit Manager will be responsible for the management and oversight of the core quality systems,...
-
Senior Quality Assurance Supervisor
2 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob Summary:The Senior Quality Assurance Supervisor will oversee the Client Support processes and personnel, ensuring staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines.Key Responsibilities:Supervise Client Support processes and personnel.Ensure staff are fully trained on all cGMP manufacturing...
-
Quality Systems Audit Manager
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryCatalent Inc is seeking a highly skilled Quality Systems Audit Manager to join our team. As a key member of our quality assurance department, you will be responsible for managing and overseeing the core quality systems, including investigation/deviation management, CAPA tracking, change control, risk management, and quality metric tracking.Key...