Manager, Manufacturing Technical Operations

Summary:

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 (https://biologics.catalent.com/our-locations/north-america/baltimore-usa/) . 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.

The Manager, Manufacturing Technical Operations (MTO) is responsible for oversight and leadership of MTO group that supports manufacturing operations at Catalent. The Manufacturing Technical Operations group functions include investigations, deviations, continuous improvement (change controls, CAPAs) operational excellence (major projects), technology transfer support, manufacturing document generation & revision, bill of materials (BOM) management, operations data analytics & metrics, manufacturing finite scheduling and manufacturing suite & readiness.

This is a full-time on-site position, M-F 8am-5pm

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role:

Build, lead and manage the MTO group to support on-going and future manufacturing operations ensuring staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines

Manage the interface of the MTO group with internal stakeholders and clients through proactive communication and accountability for on-time project/work completion; Interacts with clients on projects and presentations; Oversees and coaches team member client interactions

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

Supports technology transfer teams led by MS&T providing the manufacturing representative or coordinating manufacturing representation

Provides effective oversight and coordination of manufacturing document generation & revision, bill of materials (BOM) management, operations data analytics & metrics, manufacturing finite scheduling and manufacturing suite & readiness to ensure timely completion

Other duties as assigned

The Candidate:

Masters’ degree in a Scientific, Engineering or Biotech field with 3 years’ experience in cGMP production &/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

– OR –

Bachelor’s degree in a Scientific, Engineering or Biotech field with 6 years’ experience in cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities

NOTE: Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience

Minimum 3 years of progressive leadership experience, including performance management and people development

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

Previous experience operating equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment

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

The anticipated salary range for this position in Maryland is $118,720 $163,240 plus annual bonus, when eligible. 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.

Position Benefits:

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

152 hours of paid time off annually 8 paid holidays

Competitive salary with yearly bonus potential

Community engagement and green initiatives

Generous 401K match and Paid Time Off accrual

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 (https://careers.catalent.com/us/en) 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 DisabilityAccommodations@catalent.com . 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.

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