Clinical Supplies Manager
About the job
- A bachelor's degree in a science, supply chain, or related discipline.
- At least 6 years of relevant industry experience, including at least 4 years in clinical supply management, with demonstrable knowledge of the complete clinical supplies life cycle.
- Experience with supply tracking requirements and systems.
- Experience using forecasting tools.
- Global logistics experience and understanding of supply chains, import/export, drug depots, comparator or co-therapy product sourcing, and project management.
- Working knowledge of International Conference on Harmonization guidelines, Good Clinical Practice, the Code of Federal Regulations, EMA Good Manufacturing Practice and Good Distribution Practice Guidelines, and Good Manufacturing Practices.
- Working knowledge of global supply labeling requirements.
- Understanding of the roles, responsibilities, and interdependencies of key functions involved in clinical supply.
- Strong knowledge of Interactive Response Technology as it relates to supply chain management.
- Interpret clinical study protocols and translate requirements into accurate clinical drug supply forecasts.
- Develop and maintain study drug demand projections and supply plans throughout the lifecycle of clinical studies.
- Use simulation tools and supply chain expertise to design efficient, risk-based clinical supply strategies.
- Monitor study progress and reforecast supply requirements based on enrollment, country, site, or protocol changes.
- Manage Interactive Response Technology supply strategy, including specification development, threshold recommendations, User Acceptance Testing, and ongoing oversight.
- Oversee drug inventory levels across depots and warehouses, ensuring continuity of supply and avoiding stock-outs.
- Coordinate drug manufacturing, packaging, and distribution activities with clients, vendors, and internal stakeholders.
- Support budgeting, process improvement, training, and business development activities to enhance clinical supply operations.
- Strong knowledge of Interactive Response Technology as it relates to supply chain management.
- Experience in client relationship management and the ability to influence customer demand.
- Experience with Microsoft Office programs, particularly Microsoft Project and Microsoft Excel.
About the company
Catalent provides end-to-end development, manufacturing, clinical supply, and packaging services for pharmaceutical, biotechnology, and consumer health clients. It develops formulations, scales manufacturing, and delivers clinical and commercial materials through an integrated supply chain under long-term partnerships tailored to each project. It differentiates itself through a broad, fully integrated service offering, lasting client relationships, and a focus on efficiency across the development and supply chain, along with commitments to sustainability. Its goal is to help clients accelerate product development and commercialization while managing costs, quality, and environmental impact across the product lifecycle.
Company Size
5,001-10,000
Company Stage
IPO
Headquarters
Franklin Township, New Jersey
Founded
1996
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Simplify's Take
What believers are saying
- August 25, 2026 refinancing cut interest $100 million and lifted liquidity to $1.1 billion.
- ALK, Nanoscope, and Elpida expanded Catalent partnerships in 2026.
- Novo Holdings' backing funded debt markets' confidence and multi-year capacity investments.
What critics are saying
- Catalent will close Gosselies, Belgium, eliminating about 150 jobs after January 2026.
- FDA hit Bloomington, Indiana with Form 483 and OAI; Scholar Rock dropped it.
- Persistent FDA findings and demand cuts can strand Catalent's gene-therapy network.
What makes Catalent unique
- Catalent's Zydis platform secured ALK's September 30, 2026 capacity expansion.
- Taysha named Catalent primary commercial manufacturer on August 3, 2026.
- Nearly 40 global sites let Catalent span development, fill-finish, packaging.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
401(k) Company Match
Paid Vacation
Paid Holidays
Tuition Reimbursement
Wellness Program
Company News
ALK expands strategic tablet supply partnership with Catalent. September 30, 2026 09:03 ET | Source: ALK Abello Inside Information * Agreement provides long-term expanded access to Catalent's fast-dissolving (Zydis(R) tablet formulation technology. * Supply robustness secured with prioritised manufacturing capacity increase of ~40% to 1.1 billion tablets annually from early 2030s. * Over three years, ALK to invest DKK 500 million in capacity at Catalent. ALK (ALKB:DC / Nasdaq Copenhagen: ALK B) today announced that it has expanded its long-standing contract manufacturing partnership with Catalent, Inc. ("Catalent"), a leader in enabling the development and supply of better treatments for patients worldwide. Establishing long-term supply robustness is a strategic priority for ALK, and the expanded agreement secures ALK long-term access to Catalent's Zydis(R) technology for all its allergen products, including potential future tablets for peanut and tree nut allergies. The agreement also secures additional production capacity to sustain the expected future demand for ALK's SLIT (sublingual immunotherapy) tablet portfolio. Based on production sites in the UK and Canada, ALK expects to increase its annual tablet capacity by an additional 300 million to 1.1 billion tablets from early 2030s and beyond. Peter Halling, President & CEO, said: "We are very pleased to reinforce our long-standing collaboration with Catalent, which plays an important role in producing ALK's SLIT tablets. This partnership, already in place for more than two decades, has the potential to become one of the longest lasting in pharma. The expanded partnership underscores the unique durability of our core business model - with no patent cliff to manage - while the strengthened supply chain and added capacity secure our ability to serve many more people with allergy for years to come." Terms and financials Under the terms of the agreement, ALK will commit total payments to Catalent of approximately DKK 500 million to secure the capacity expansion. These payments will be capitalised over three years on the balance sheet under 'prepayments' and amortised over the duration of the contract. The development in future manufacturing costs is expected to offset these initial payments over time. The agreement does not affect ALK's financial guidance for 2026 or ALK's long-term financial targets. ALK-Abelló A/S For further information please contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Maiken Riise Andersen, tel. +45 5054 1434 This announcement contains inside information. This is information that ALK-Abelló A/S is obliged to make public pursuant to the EU Market Abuse Regulation. About ALK ALK is a global specialty pharmaceutical company focused on allergy. ALK's activities cover the entire value chain of developing, sourcing, producing, and marketing a diversified portfolio of products for diagnosing and treating respiratory allergies and severe allergic reactions (anaphylaxis) in both children and adults. Headquartered in Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen (Nasdaq: ALK B). Visit us at www.alk.net. About Catalent Catalent, Inc. is a leading global contract development and manufacturing organisation (CDMO) delivering tailored, end-to-end solutions across all phases of development and manufacturing for pharma, biotech and consumer health customers, and supplying billions of doses annually from nearly 40 global sites. Among its proprietary technologies is Zydis(R)[,] a freeze-dried orally disintegrating tablet formulation that disperses almost instantly in the mouth, offering a fast, convenient and palatable dosage form - particularly suited to patients, such as children, who may struggle with conventional tablets.
Catalent has completed a debt refinancing transaction to enhance its financial flexibility and expand capacity in high-demand areas. The deal includes a new $4.1 billion seven-year Term Loan B facility and a $600 million revolving credit facility, expected to reduce annual interest expenses by approximately $100 million. The CDMO plans to invest in its Zydis orally disintegrating tablet platform and expand domestic biologics manufacturing, including larger-scale bioreactor capacity at its Madison site. The company is also capitalising on US onshoring trends by expanding domestic capacity. The refinancing follows Novo Holdings' $16.5 billion acquisition of Catalent in 2023, with plans to double the company's size over five years. Catalent now has approximately $1.1 billion in available liquidity.
Ritedose appoints Carolyn Berg as new Vice President of Strategic Growth. The role will focus on identifying new opportunities and strengthening existing customer relationships to accelerate Ritedose's continued growth. COLUMBIA, S.C., Sept. 10, 2026 (GLOBE NEWSWIRE) - The Ritedose Corporation (Ritedose), the largest contract development and manufacturing organization (CDMO) in the United States specializing in sterile Blow-Fill-Seal (BFS) production of unit-dose solutions for the ophthalmic and respiratory markets, today announced the appointment of Carolyn Berg as the company's Vice President of Strategic Growth. Berg brings more than 25 years of domestic and international experience in marketing, sales and business development. Prior to joining Ritedose, Berg served as Vice President of Business Development for Catalent's inhaled drug delivery solutions, where she led commercial strategy and global sales efforts to expand the company's inhalation business. Earlier in her career, she held leadership roles at Cipla, Teva Respiratory and Merck, building extensive experience in business development, portfolio strategy, strategic marketing, product commercialization and commercial leadership. "As Ritedose continues to expand its capabilities and position itself for the next phase of growth, Carolyn's leadership will be instrumental in identifying new opportunities and ensuring our growth remains centered on the customers and patients we serve," said Jody Chastain, President and CEO of Ritedose. "Carolyn brings a tremendous depth of commercial experience, a proven understanding of the pharmaceutical markets we serve, and a collaborative approach to leadership." In her new role, Berg will advance Ritedose's commercial strategy, strengthen relationships with existing customers and identify new opportunities to support the company's continued growth in the inhalation and ophthalmic markets, as well as future market expansions. The appointment reflects Ritedose's continued growth and strategic investment in its leadership, infrastructure and capabilities needed to accelerate the Company into its next chapter. "Ritedose has built an impressive platform for delivering high-quality sterile medicines, and I'm excited to join the company at such an important inflection point in its growth trajectory," said Berg. "There is a significant opportunity to build on Ritedose's strengths in ophthalmic and respiratory manufacturing while deepening our relationships with existing customers and developing new strategic partnerships. I look forward to working with my Ritedose colleagues to identify opportunities that create value for our customers and help bring safe and high-quality therapeutics to patients who need them." Berg earned bachelor's degrees in Journalism/ Public Relations and French from the University of Texas at Austin and an International MBA from the Darla Moore School of Business at the University of South Carolina. About The Ritedose Corporation Ritedose is the largest sterile contract development manufacturing organization (CDMO) in the US specializing in sterile Blow Fill Seal (BFS) technology that ensures sterile, consistent, and safe unit dose delivery. The company's process guides pharmaceutical partners from pre-IND and CMC development through commercialization of branded and generic inhalation and ophthalmic medications. of branded and generic inhalation and ophthalmic medications. With a focus on quality, innovation, and customer satisfaction, Ritedose partners with leading pharmaceutical companies to deliver safe, effective, and reliable medications that improve patient outcomes. For more information about Ritedose and its services: visit Ritedose.com. Media Contact Alex Keown Inspire Agency on behalf of Ritedose [email protected] 630-346-5141
Catalent, a global contract development and manufacturing organisation, has completed a debt refinancing transaction. The refinancing includes a new $4.1 billion seven-year term loan B facility and a $600 million revolving credit facility, replacing the company's existing term loan B. The transaction is expected to reduce Catalent's annual interest expense by approximately $100 million. Following completion, the company has approximately $1.1 billion of available liquidity, including cash on hand and access to its revolving credit facility. The debt refinancing was led by JP Morgan and Morgan Stanley. Catalent's debt received ratings of B1 from Moody's and B+ from S&P, both with stable outlooks.
Scholar Rock (NASDAQ: SRRK) drops Catalent Indiana as fill-finish site from apitegromab drug application. Scholar Rock (NASDAQ: SRRK) announced Friday that it has removed Catalent Indiana as a fill-finish facility from its Biologics License Application for apitegromab, acting under guidance from the FDA. The decision marks a notable development in the regulatory pathway for apitegromab, Scholar Rock's lead investigational treatment targeting muscle mass and strength in spinal muscular atrophy patients. Fill-finish manufacturing is a critical final stage of biologic drug production, involving the transfer of a drug substance into its final container before it reaches patients. Regulatory agencies frequently scrutinize fill-finish facilities as part of the BLA review process, and any changes to designated sites can carry significant implications for approval timelines. Scholar Rock confirmed the move was made under direct guidance from the FDA, suggesting the agency raised concerns or flagged the Indiana facility as part of its ongoing review. Catalent, a contract development and manufacturing organization, has faced heightened regulatory scrutiny across several of its manufacturing sites in recent periods. Novo Nordisk (NVO) has a financial stake in Catalent, which adds a layer of industry significance to the removal of the Indiana facility from Scholar Rock's application. The timing of the announcement, coming on a Friday morning, prompted a market reaction, with shares of Scholar Rock rising 2.26% while Novo Nordisk gained 1.30% on the session. Investors and analysts will now be watching closely for any updated guidance from Scholar Rock on how this manufacturing change may affect the expected timeline for FDA action on the apitegromab BLA. Scholar Rock has positioned apitegromab as a potentially transformative therapy, and any delays or complications in the regulatory process carry material consequences for the company's commercial outlook and financial position. The company has not yet indicated which alternative fill-finish facility will replace Catalent Indiana in the updated application, a detail that market participants will be eager to see clarified in the near term.