Full-Time

Associate Scientist 2

Analytical Research & Development

Posted on 8/15/2025

Deadline 10/10/25
Catalent

Catalent

5,001-10,000 employees

Global contract drug formulation, manufacturing, packaging

No salary listed

St. Petersburg, FL, USA

In Person

Category
Lab & Research (1)
Requirements
  • Associate’s in science with 10 plus years in an analytical lab, 5 in GMP environment OR
  • Bachelor’s in science with 3 plus years in an GMP analytical lab
  • Experience with common pharmaceutical equipment: UV/VIS, IR, AA, and Dissolution required
  • Expertise in wet chemistry techniques such as titrations, extractions as per compendia required
  • Familiar with separation chromatographic instruments such as HPLC/UHPLC and GC required
Responsibilities
  • Perform compendial and non-compendial testing on raw materials, drug substances, in-process samples, cleaning samples and finished products as required
  • Performs assay/CU/dissolution and other single analyte chromatographic testing. Prepares reagents, standards, media and mobile phase as needed for analyses
  • Required to work with potent and teratogenic compounds with proper PPE equipment. Disposal of hazardous waste according to environmental regulations and company procedures
  • Tabulation/ interpretation of results of analysis as recorded in notebooks, reports and logbooks. Assures right-first-time execution of departmental methods and SOPs
  • Supports activities and services necessary to the operations of the department, as assigned. Writes/ reviews analytical methods, deviations, protocols, SOPs and other technical documents
  • Supports Material Evaluation Process for new materials. Shares responsibility for the routine calibration of analytical equipment such as, but not limited to balances, pH meters, KF analyzers, AA, IR, etc
  • Provides project support for new product development programs under the direction of the lead scientist or group leader. Assist with laboratory investigations using the appropriate Root Cause Analysis tools
  • Participates in inter-departmental task teams. Interfaces with peers in other departments and management. Identifies/implements improvements that will reduce cycle time for testing/release products
  • Other duties as assigned
Desired Qualifications
  • Familiar with pharmaceutical software such as LIMS, TrackWise, Empower, preferred
  • Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent’s in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.

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

Simplify Jobs

Simplify's Take

What believers are saying

  • FDA approved Catalent's iPSC line for Cartherics' CTH-401 CAR-NK product.
  • SmartCella licenses Catalent GMP iPSCs for Parkinson's and cardiac therapies.
  • New Tampa headquarters supports strategic expansion post-Novo acquisition.

What critics are saying

  • FDA warning letter to Indiana site cites contamination and investigation failures.
  • Two Form 483s at Maryland gene therapy sites halt Sarepta production.
  • Ardena acquisition strips Somerset facility, eroding oral solids capacity.

What makes Catalent unique

  • Catalent licenses cGMP iPSC lines for CAR-NK therapies with Cartherics.
  • Catalent advances lipid-based softgels for oral macromolecule delivery.
  • Catalent develops psilocin delivery systems with NeoLumina for mental health.

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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

Connectweb Technologies, Inc.
Apr 10th, 2026
Cartherics and Catalent expand commercial license agreement.

Cartherics and Catalent expand commercial license agreement. Cartherics Pty Ltd Melbourne, Australia, and Tampa, FL - Cartherics Pty Ltd, a biotechnology company developing off-the-shelf immune cell therapies for high-impact women's diseases, including ovarian cancer and endometriosis, and Catalent, Inc., the leader in enabling the development and supply of better treatments for patients worldwide, today announced an enhanced partnership. The companies have signed an amended commercial license agreement enabling the use of a Catalent cGMP-compliant induced pluripotent stem cells (iPSC) line for the manufacture and commercialization of Cartherics' iPSC-derived Chimeric Antigen Receptor Natural Killer (CAR-NK) cell therapies. The agreement supports Cartherics' mission to develop immune cell therapy products for the treatment of cancer and endometriosis. Dr. Ian Nisbet, CEO of Cartherics, commented: "We are delighted to have established a collaborative relationship with Catalent, a leading cell and gene therapy CDMO, to expedite the development of our CAR-NK cell products. We are confident that our collaboration with Catalent will underpin cost-effective manufacturing of our products." "We are thrilled to broaden our partnership with Cartherics and support the important work the company is doing to develop Natural Killer cells for the treatment of cancer," said David McErlane, Biologics Group President for Catalent. "Our teams are highly engaged in achieving positive outcomes across all stages of development, and we look forward to advancing Cartherics' program toward commercialization." Under the terms of the agreement, Cartherics is granted rights to develop and commercialize multiple product candidates derived from a Catalent off-the-shelf cGMP iPSC line, including its lead CAR-NK cell product, CTH-401. The licensed iPSC line is part of a broader portfolio of fully characterized, donor-consented, clinical-grade iPSC lines generated under GMP conditions, supported by validated workflows for reprogramming, expansion, gene editing, differentiation and quality control. With Catalent's support, Cartherics has already obtained approval from the U.S. Food and Drug Administration (FDA) for use of the licensed iPSC line as the starting cell for generation of Cartherics' CTH-401. The two companies have also demonstrated full compatibility between CTH-401 and Catalent's iPSC-NK manufacturing platform. The agreement enhances Cartherics' manufacturing capabilities by providing a robust framework for collaboration and incentives for utilizing Catalent as its contract manufacturing organization for late-stage clinical trials and commercial supply. Importantly, Cartherics retains the ability to manufacture clinical trial material and retains the right to participate in downstream manufacturing as the partnership evolves. Both companies view this collaboration as an important step forward in delivering innovative cell therapy solutions to improve patient outcomes around the world. About Catalent Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) championing missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech and consumer health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers' needs in all phases of development and manufacturing. With thousands of scientists and technicians and the latest technology platforms at nearly 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. About Cartherics Cartherics Pty Ltd is a privately held biotechnology company based in Melbourne, Australia developing off-the-shelf immune cell therapies focusing on high-impact women's diseases, with lead programs in ovarian cancer and endometriosis. The Company's allogeneic ("off-the-shelf") cell platform is based upon induced pluripotent stem cells (iPSCs) generated from donated cord blood that can be differentiated into NK cells, T cells and other cells of the immune system. The iPSCs are genetically engineered at specific "safe harbour" genomic sites to provide enhanced function for the derived NK and other immune cells. The Company's lead product, CTH-401, is a CAR-iNK cell product. It carries a CAR directed against TAG-72, a well-validated tumour target, along with the deletion of two genes associated with immunosuppression. The company has a strong pipeline of additional novel CAR-immune cell products tailored to disrupt a variety of cancers including; ovarian, triple negative breast cancer and other solid tumours; and is also targeting severe endometriosis with specific NK cell products. Contact details: Cartherics Christine Filippis Teraze Communications Phone: +61 419 119 866

BioSpace
Jan 12th, 2026
SmartCella and Catalent Sign Nonexclusive License Agreement for GMP iPSCs

SmartCella and Catalent sign nonexclusive license agreement for GMP iPSCs. TULLINGE, Sweden & TAMPA, Fla.-(BUSINESS WIRE)-SmartCella Holding AB ("SmartCella"), a global biopharma company developing and manufacturing cutting-edge cell therapy approaches for difficult-to-treat diseases, and Catalent, Inc., the leader in enabling the development and supply of better treatments for patients worldwide, today announced a nonexclusive license agreement for SmartCella to use Catalent's proprietary off-the-shelf GMP compliant induced pluripotent stem cells (iPSCs) for research, development and clinical translation of novel allogeneic stem cell-based regenerative therapies. The partnership supports research and development of regenerative medicines targeting cardiac disease and Parkinson's disease. "As a global CDMO with leading capabilities developing iPSCs and iPSC-derived cell therapies, Catalent is pleased to partner with SmartCella, a leading biopharma advancing innovative cell-based therapeutics." said David McErlane, Biologics Group President at Catalent. "Together, we aim to accelerate the development of transformative iPSC-based therapies for patients living with cardiac failure and Parkinson's disease and bring SmartCella's vision closer to patients - driving innovation and the potential to improve outcomes worldwide." "Access to robust, well-characterized iPSC lines is a critical enabler of our Regenerative Medicines technology platforms. It provides a strong foundation for scalable manufacturing of iPSC-derived therapies that de-risk scale-up and future GMP implementation. It also underpins our development efforts and partnerships, with current focus on Parkinson's disease, cardiac failure and osteoarthritis. We are pleased to partner with a world-renowned CDMO leader such as Catalent as we advance these programs," said Ricardo Baptista, Chief Technology Officer at SmartCella. About SmartCella SmartCella is a global biopharma company that combines biotech methods and medical science to develop therapies from living systems and pioneers targeted therapies and precision medicine approaches for difficult-to-treat diseases through delivery solutions and advanced therapy development. Founded in 2014, the company is built on globally renowned research at Karolinska Institutet in Sweden. SmartCella combines novel delivery platforms, such as the Extroducer(R)(an endovascular delivery device that enables direct injection into hard-to-reach organs and tumors), with the development and manufacturing of cell therapies. The company has two operating segments: Targeted Delivery and Regenerative Medicines. An international team of scientists, innovators, and experienced business leaders works to deliver the future of targeted therapies and develop life-changing treatments. Read more www.smartcella.com and follow SmartCella on LinkedIn. About Catalent Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) championing the missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech and consumer health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers' needs in all phases of development and manufacturing. With 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. For more information, visit www.catalent.com. SmartCella: Nina Nornholm, Head of Communication & Investor Relations +46 708 550 356 Catalent: Laura Hortas, Vice President, Corporate Communications [email protected]

Endpoints News
Dec 19th, 2025
Catalent handed two Form 483s, including for Sarepta gene therapy site

Catalent handed two Form 483s, including for sarepta gene therapy site. News reporter. Prior to last month's series of mass layoffs in Maryland, Catalent was issued two Form 483s for its gene therapy facilities in the state, which... Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.

Massachusetts Biotechnology Council
Nov 19th, 2025
From Needle to Capsule: How Lipid-Based Softgels Are Making Oral Delivery of Macromolecules a Reality

From needle to capsule: how lipid-based softgels are making oral delivery of macromolecules a reality. MassBio is partnering with Catalent Pharma Services on November 20 to host R&D Reimagined, a new event designed to connect biotech and pharma R&D leadership with the industry leaders transforming the life sciences with new technologies and services. My work in drug product development over the past thirty years has always focused on practical ways to solve challenging drug delivery problems. One of these challenges is: freeing the patients from the needles? Anyone who works with peptides, proteins, or nucleic acids knows how difficult the oral delivery has been. These large, fragile, and hydrophilic molecules rarely survive the gastrointestinal tract, and even when they do, they struggle to cross the intestinal barrier. What did not seem possible even a decade ago is now moving into real clinical territory. Lipid-based formulations inside advanced softgels are playing a major role in that shift. Why oral macromolecules have been so difficult. When people ask me why oral delivery has taken so long, I point to three barriers that appear in every program I've ever touched. * Stomach acid and proteolytic enzymes destroy unprotected peptides within minutes. * Molecules like insulin, at 5.8 kDa, are far too large for passive paracellular transport. * Hydrophilic and charged surfaces resist interaction with the lipophilic intestinal membrane. For years, these issues made oral macromolecules feel out of reach. Lipid-based systems change the equation because they tackle all three barriers at the same time. How lipid formulations and smart softgels create a pathway. What excites me most is how versatile lipid systems have become. Massachusetts Biotechnology Council Inc now have well-characterized mechanisms that give Massachusetts Biotechnology Council Inc multiple levers to protect a molecule and guide it toward absorption. When the fill and the shell are optimized as one system, Massachusetts Biotechnology Council Inc routinely see bioavailability increase from less than 1 percent to 5 - 25 percent in preclinical models, and in some cases into double-digit ranges clinically. That type of improvement is meaningful for chronic diseases where injections reduce adherence. The softgel shell: the unsung hero. I've spent years working on softgel shell technologies, and I can say with confidence that the shell is far more than packaging. It actively controls where and how a formulation releases. Catalent's OptiGel(R) DR platform, using gelatin with pectin or selected polymers, holds up in gastric acid and releases the fill only when conditions become favorable in the duodenum or jejunum. If the shell and fill are not compatible, even the most sophisticated lipid formulation loses its advantage. The success of oral macromolecule delivery depends on getting both pieces right. Real-World proof points. One of the strongest signals that this field has turned a corner is the number of approved or late-stage programs already using these principles. * Cyclosporine (Neoral(R) and Voclosporin (Lupkynis(R): SNEDDS formulations reduced variability and improved absorption; Neoral(R) remains a benchmark decades later. * Octreotide (Mycapssa(R): A permeation-enhanced enteric capsule now provides an oral alternative for acromegaly maintenance therapy. * Sulodexide: A ~6.5 kDa glycosaminoglycan mixture reaching 30 - 60 percent bioavailability in softgels shows that large polysaccharides can cross the gut with the right design. * Salmon Calcitonin: Oral approaches using caprylate derivatives and enzyme inhibitors have progressed as far as Phase III. * Oral Insulin: Lipid-enteric capsule technologies continue in clinical evaluation, including new Phase III efforts building on lessons from prior trials. These are not theoretical exercises. They are real programs demonstrating what becomes possible when formulation science aligns with biological reality. The road ahead: opportunities and manageable hurdles. The momentum behind oral macromolecule delivery is strong, and the next wave of tools is already emerging. * New GRAS ionizable lipids, inspired by mRNA vaccine platforms, may offer pH-triggered release and improved protection. * AI-guided screening of oil and surfactant ratios is shortening early formulation cycles. * Mini-softgels open the door for pediatric and geriatric patients who avoid injections whenever possible. * Droplet-size drift during encapsulation requires disciplined process control. * High-fat meals can increase exposure three to five times, so administration guidance is essential. * Lipid excipients cost more than standard tablet matrices, but improved adherence and reduced cold-chain needs help offset this. Closing thought. I've watched the industry move past "impossible" many times. Transdermals, implants, and pulmonary delivery all started that way. Oral macromolecules are now advancing along that same path. When a patient with diabetes, acromegaly, or a rare disease can swallow a capsule instead of facing a needle, everything improves: adherence, access, and quality of life. The science is ready, the technologies are in hand, and execution is underway. I'm proud to lead the teams advancing this shift and turning the science into real therapeutic progress.

NeoLumina Bioscience Inc.
Nov 7th, 2025
NeoLumina Partners with Catalent to Pioneer Psilocin Delivery, Marking a Major Leap in Psychedelic Med for Mental Health

NeoLumina partners with Catalent to pioneer Psilocin Delivery, marking a major leap in psychedelic med for Mental Health. Pioneering Precision: NeoLumina and Catalent Partner to Redefine Psilocin Delivery for Mental Health Treatment. VANCOUVER, BRITISH COLUMBIA, CANADA, November 7, 2025 /EINPresswire.com/ - NeoLumina BioScience Inc., a pioneering clinical-stage biopharmaceutical company dedicated to developing breakthrough treatments for mental health disorders using psychedelics, follows up on its previous announcement on July 17, 2025, whereby a development agreement has been signed with Catalent, Inc., a leading global provider of advanced delivery technologies, and development and manufacturing solutions for drugs, biologics, and consumer health products. This collaboration aims to leverage proprietary technology and Catalent's expertise in drug delivery to develop a first-in-class psilocin delivery product, capable of providing consistent, pre-determined doses of the active compound derived from psilocybin, intended for the treatment of various mental health disorders. Concurrently, NeoLumina is preparing to seek FDA approval to initiate a Phase 2 clinical trial for its lead clinical-stage psilocybin-based product candidate, PEX010, in the treatment of binge eating disorder. NeoLumina holds exclusive global rights to PEX010 for eating disorders. Dr. Michael Murray, ND, a leading authority in natural medicine, commented, "I am confident that the partnership between NeoLumina and Catalent will be highly successful. Their combined expertise in natural medicine and drug delivery technology, respectively, holds great promise for the development of innovative treatments for mental health disorders." "We are pleased to partner with Catalent, a recognized leader in drug delivery technology," said Dr. Gaetano Morello, ND., CEO of NeoLumina. "We believe this collaboration will create a novel psilocin delivery system and advance our mission to provide innovative treatments for mental health disorders. We look forward to working together to create a unique new product to treat various psychological conditions while we simultaneously advance our lead product candidate into Phase 2 clinical trials." NeoLumina remains committed to advancing therapies that can address unmet needs in mental health care. About NeoLumina BioScience Inc. NeoLumina BioScience is dedicated to pioneering innovative psychedelic-based treatments for mental health disorders. Its mission is to leverage cutting-edge scientific research and proprietary technology to develop novel, effective, and safe therapies that transform lives worldwide. For more information, please contact: Jeremy Baker - NeoLumina Bioscience Inc +1 833-303-1883 email Neoluminabio here Visit Neoluminabio on social media: Facebook / Twitter / LinkedIn / Instagram About NeoLumina BioScience Inc. NeoLumina BioScience is dedicated to pioneering innovative psychedelic-based treatments for mental health disorders. Its mission is to leverage cutting-edge scientific research and proprietary technology to develop novel, effective, and safe therapies that transform lives worldwide. Forward looking statements. To the extent statements contained in this news release are not descriptions of historical facts regarding NeoLumina Bioscience Inc. they should be considered "forward-looking statements," as described in the private securities litigation reform act of 1995, that reflect management's current beliefs and expectations. You can identify forward-looking statements by words such as "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "hope," "hypothesis," "intend," "may," "plan," "potential," "predict," "project," "should," "strategy," "will," "would," or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. Forward-looking statements contained in this news release include, but are not limited to, statements regarding: (i) the success and timing of its product development activities and clinical trials; (ii) its ability to develop its product candidates; (iii) its plans to research, discover, evaluate and develop additional potential product, technology and business candidates and opportunities; (iv) the anticipated timing of clinical data availability; (v) its ability to meet its milestones; and (vi) its expectations regarding its ability to obtain and maintain intellectual property protection. Forward-looking statements are subject to known and unknown factors, risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such forward-looking statements. Undue reliance should not be placed on forward-looking statements. Neoluminabio undertake no obligation to update any forward-looking statements.

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