Job Information
Catalent Pharma Solutions Senior Manager, Sample Management in Harmans, Maryland
Senior Manager, Sample Management
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 Senior Manager, Sample Management is responsible for overseeing and ensuring the efficient and compliant management of QC and client samples throughout their lifecycle, from receipt to storage, testing, and distribution. This role requires strong leadership in managing a team of sample management professionals, optimizing processes, and ensuring regulatory compliance. The Senior Manager will work closely with cross-functional teams, including Quality Control, Manufacturing, Supply Chain, and Project Management to meet organizational and client needs while maintaining the highest standards of quality and compliance.
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:
Lead and manage a team of QC and client sample management professionals, providing direction, coaching, and performance management.
Develop and execute training programs to ensure staff is knowledgeable on sample management best practices, regulatory requirements, and internal SOPs.
Set clear goals and performance metrics for the team and conduct regular performance reviews to assess progress and identify areas for development.
Oversee the receipt, cataloging, storage, and distribution of both QC and client samples in accordance with regulatory requirements and internal standards.
Ensure the proper storage conditions for QC and client samples to maintain sample integrity (e.g., temperature-controlled environments, segregation of samples, etc.).
Ensure timely and accurate distribution of QC and client samples to various departments (e.g., Quality Control, Supply Chain, Manufacturing) and external clients when required.
Serve as the main point of contact for any issues related to QC and client sample handling, ensuring quick resolutions to any challenges that arise.
Ensure that all sample management activities comply with relevant regulatory standards, including GMP, GDP, and applicable guidelines from regulatory agencies (FDA, EMA, etc.).
Maintain rigorous sample tracking systems to ensure full traceability of both QC and client samples throughout their lifecycle.
The Candidate:
Bachelor's degree in science or related field required (Chemistry, Microbiology or Biology preferred)
A minimum of 5-8 years of experience in a Quality Control or Supply Chain role within a regulated environment (pharmaceutical or medical device industry preferred).
4 – 6 Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict
In-depth knowledge of GMP, GDP, and other relevant regulatory standards (FDA, EMA, ICH, etc.).
Experience managing both QC and client samples, including tracking, storage, and distribution requirements.
Strong organizational skills with the ability to manage multiple priorities and projects in a fast-paced environment.
Proficiency with sample management software and inventory tracking systems.
Excellent attention to detail and accuracy in managing sample records and inventory.
The anticipated salary range for this position in Maryland is $152,800 to $210,100 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:
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) .