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Supervisor, QA OTF Support

Summary:

_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._

_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._

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

The **Supervisor, QA OTF Support** is responsible for providing quality oversight for the “QA on the Floor” program in accordance with Catalent policies, standards, procedures and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations on the floor to resolve manufacturing issues. This position is required to be present on the floor for 70% of the day.

This is a full-time on-site position, 7pm-7am 2-2-3 rotation

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:

+ Provide oversight of the “QA on the Floor” program and supervision of OFT processes and personnel.

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

+ Build effective teams that apply their diverse skills and perspectives to achieve common goals while driving engagement and create a culture where employees are motivated to do their best.

+ Oversee daily activity for the group to ensure quality results Performance management for direct reports.

+ Drives and owns the “Quality on the Floor” program by facilitating the desired ‘way of working’ and a quality culture.

+ Plans and coordinates the activities of the OTF team to ensure coverage for all manufacturing activities

+ Provide QA oversight, technical expertise and leadership across all aspects of product manufacturing and operations support.

+ Develop and update relevant procedures.

+ Monitor, participate and oversee the real time batch record review process, including escalation of issues while on the floor.

+ Ensure manufacturing compliance with applicable procedures and batch records.

+ Review manufacturing shop floor documentation, including logbooks, calibrations etc

+ Ensure that own and teams KPI’s, plans, targets and objectives are effectively monitored and achieved. Including standard lead-times and supporting the Business goals for e.g. RFT and OTD/ OTIF

+ Embrace and actively drive Practical Process Improvements (PPI). Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

+ Partner with manufacturing and key stakeholders to prioritize projects aligning with the quality goals and objectives.

+ The supervisor will have a key role with resolution of quality investigations and CAPAs. Ensuring quality events are captured, investigated and closed appropriately in the Trackwise system.

+ Actively participates in training activities, managing their individual training plan.

+ Leads by example, keeping in mind organizational values, policies and goals. Develops people and team coaching and collaboration.

+ Proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding is a success.

+ Other duties as assigned

The Candidate:

+ Masters’ degree with 4 - 6 years’ experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry. Scientific or life science discipline degree preferred.

+ OR

+ Bachelor’s degree with 6 – 8 years’ experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry. Scientific or life science discipline degree preferred.

+ Familiar with GMPs (21 CFR Parts 210, 211, 600s), ICH, and EU GMPs.

+ Knowledgeable in biological processes (cell culture, fermentation, purification, fill/finish) and applying scientific/regulatory principles.

+ Familiar with electronic systems (Microsoft, LIMS/Master Control/Trackwise preferred), possesses analytical, troubleshooting, and decision-making skills.

+ Quick learner of new processes, able to work independently and collaboratively, multitask, and meet deadlines in a fast-paced environment with a commitment to professional growth.

_The anticipated salary range for this position in Maryland is $93,280-$128,260 plus shift differential and 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:

+ 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 [email protected] . 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 [email protected] 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) .