Manager, Manufacturing Technical Operations

Catalent Pharma Solutions; Harmans (MD); On-site; USD 135,000 - 165,000; Full time

Benefits offered by this job

Paid time off

Health benefits

Tuition reimbursement

8 paid holidays

Job summary

Catalent Pharma Solutions seeks a Manager of Manufacturing Technical Operations to lead and oversee the MTO group, ensuring alignment with cGMP standards and safety. The role interfaces with clients and internal stakeholders to ensure timely project completion and high-quality manufacturing support.

You will drive continuous improvement, manage document control, and coordinate with Technology Transfer and Manufacturing Science teams to support site objectives.

Qualifications

• Master’s degree with 6+ years GMP/QA experience
• Bachelor’s degree with 8+ years GMP/QA experience
• Minimum 3 years of progressive leadership experience
• Knowledge of GMP, FDA regulations, and documentation procedures
• Experience in quality systems and deviation investigations
• Ability to lead cross-functional teams and manage projects on time and budget
• Excellent communication and technical writing skills
• Leadership experience at Catalent may count toward external experience

Responsibilities

• Build, lead, and manage the Manufacturing Technical Operations group to support current and future manufacturing
• Ensure staff are trained on cGMP operations and documentation while upholding safety
• Oversee investigations, deviations, CAPAs, and change controls with measurable results

Skills

Leadership experience

Cross-functional collaboration

Communication skills

Technical writing

GMP/regulatory knowledge

Education

Master's degree in Science/Engineering/Biotech

Bachelor's degree in Science/Engineering/Biotech

Job description

Manager, Manufacturing Technical Operations Role

About Site

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC's I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

Position Summary

We have an opportunity for a Manager, Manufacturing Technical Operations to join our team. In this role, you will lead and oversee the Manufacturing Technical Operations group that supports manufacturing operations at Catalent. The team’s functions include investigations, deviations, continuous improvement, operational excellence, technology transfer support, document management, bill of materials management, data analytics, scheduling, and suite readiness. This position reports to the Director, MTO and manages a team of specialists dedicated to ensuring operational success.

The Role

Build, lead, and manage the Manufacturing Technical Operations group to support ongoing and future manufacturing operations, ensuring staff are fully trained on all current Good Manufacturing Practice operations and documentation while adhering to safety guidelines. Manage the interface of the group with internal stakeholders and clients through proactive communication and accountability for on-time project and work completion; interact with clients on projects and presentations; oversee and coach team member client interactions. Oversee daily activities for the group to ensure quality results, including performance management for direct reports and driving timely completion of major manufacturing investigations, deviations, and subsequent Corrective and Preventive Actions. Provide oversight and coordination of manufacturing continuous improvement activities such as Corrective and Preventive Actions and Change Controls, and operational excellence initiatives; establish and manage a yearly slate of improvement projects with measurable results aligned with site objectives. Support technology transfer teams led by Manufacturing Science and Technology by providing or coordinating manufacturing representation. Provide effective oversight and coordination of manufacturing document generation and revision, bill of materials management, operations data analytics and metrics, manufacturing finite scheduling, and manufacturing suite readiness to ensure timely completion. Other duties as assigned.

The Candidate Minimum Requirements

• Master’s degree in a Scientific, Engineering, or Biotech field with 6 years of experience in current Good Manufacturing Practice production and/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 of experience in current Good Manufacturing Practice production and/or quality experience, with knowledge and understanding of process, documentation requirements, and activities
• Minimum 3 years of progressive leadership experience, including performance management and people development
• Knowledge of Good Manufacturing Practices, Food and Drug Administration regulations, and documentation procedures required
• Experience in quality systems regulations; previous experience in process deviation investigations and remediation, including authoring and/or revising technical documents
• Demonstrated ability to work effectively cross-functionally, lead teams, and implement project plans on time and on budget
• Excellent communication and technical writing skills
• Solid communication skills across technical and non-technical audiences and the ability to create and communicate complex concepts and analyses in easy-to-understand ways
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Preferred Skills & Background

• Previous experience operating equipment such as incubators, single-use bioreactors, depth filtration skids, tangential flow filtration skids, chromatography skids, single-use mixers, and in-process testing equipment.

Pay

The anticipated salary range for this position in MD is $135,000 - $165,000 Plus Bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive paid time off plus 8 paid holidays
• Community engagement and green initiatives
• Medical, dental, and vision benefits effective day one of employment
• Tuition reimbursement

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.

Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives

Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to [e-mail] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.