Manufacturing Manager (Night)

Manager, Manufacturing

Position Summary:

Catalent 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. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

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 Manufacturing Manager is accountable for leading multiple teams to execute procedures for downstream (purification)manufacturing and support area of manufacturing using SOP’s and batch records. Operating production equipment for purification that may include process monitoring, purification and formulation. This position is accountable for continuous improvement of the operations and ensuring all team members are trained and training is completed on time

This is a full-time on-site position, 7pm-7am

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:

Manage and improve the purification operations of Contract Manufacturing Facility.

Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines.

Establish a continuous improvement plan to achieve excellence in accordance with The Catalent Way (TCW); deploy the plan and coach others on the journey.

Build effective teams that apply their diverse skills and perspectives to achieve common goals.

Drive engagement and create a culture where employees are motivated to do their best.

Ensure quality culture through the continuous pursuit of right first-time performance.

Understand company goals and practices and apply them when resolving a variety of problems.

Coordinate with production supervisors and project managers to execute production campaigns on-time.

Ensure batches adhere to established Quality standards.

Write and/or approve manufacturing documentation, including validation protocols, SOPs, and master batch records.

Review client processes for compatibility with plant capabilities and GMP requirements.

Work with client representatives, Process Development, and technical support to transfer manufacturing processes.

Coordinate with other departments to schedule work in processing and support areas or work that affects processing and support areas.

Identify and maintain relationships with quality vendors of supplies, instruments, and equipment.

Identify processing technologies and capabilities to add to the Catalent portfolio.

Work with QA to investigate and resolve nonconformances.

Other duties as assigned.

The Candidate:

Masters’ degree in a Scientific, Engineering or Biotech field with 6 –8 years’ experience with upstream (purification) biologic production processes under GMP compliance recommended.Experience with chromatography equipment, columns, TFF, CIP procedures and of processes to purify bulk proteins, antibodies, etc. (HIC, IEX, Affinity)

Bachelor’s degree in a Scientific, Engineering or Biotech field with 8 -10 years’ experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance recommended.

Associate’sDegree with 10 –12 years’ experience in biologics production recommended.

3 years of Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict.

One (1) year of demonstrated leadership experience (Lead role) at a Catalent site will be considered.

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.

Proficient knowledge and ability to apply scientific principles utilized to solve operational, as well as routine production tasks.

Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports.

Actively pursues learning of required skills, new skills, and new equipment.

Possesses proficient equipment understanding, including understanding equipment function and application.

Creative thinking with the ability to multi-task

Commitment to ongoing professional development

Team player who thrives in collaborative environments and revels in team success.

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.

Why you should join Catalent:

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

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.

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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .