Lifecore Biomedical Appoints Thomas Guldager as Vice President, Operations

Rhea-AI Summary

Lifecore Biomedical (NASDAQ: LFCR) has announced key leadership changes with the appointment of Thomas Guldager as Vice President of Operations and Jackie Klecker as Executive Vice President of Quality and Development Services. This organizational restructuring separates operations and quality functions to support the company's growth strategy. Guldager brings 20 years of pharmaceutical industry experience, most recently from Xellia Pharmaceuticals. The company has recently doubled its capacity through a new 5-head isolator filler installation. Klecker, with over 30 years of industry experience and 16 years at Lifecore, will focus on maintaining the company's 40+ year regulatory track record and quality management system.

Positive

• Recent installation of new 5-head isolator filler doubles production capacity
• Strategic bifurcation of operations and quality functions to support growth
• Company maintains strong 40+ year regulatory compliance track record

Negative

• None.

Brings Strong Background in Pharmaceutical Manufacturing Operations and Finance to Help Drive Performance and Productivity

Jackie Klecker Named Executive Vice President, Quality and Development Services to Focus on Sustaining Company’s Strong Regulatory and Compliance Track Record

Personnel Moves Bifurcate Operations and Quality Functions to Align with Company’s Growth Strategy and Reflect Natural Evolution of Business

CHASKA, Minn., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated contract development and manufacturing organization (“CDMO”), today announced that it has appointed Thomas Guldager as vice president, operations. An experienced pharmaceutical industry professional with extensive CDMO expertise, Mr. Guldager is highly regarded for his strong operations and finance background, which Lifecore believes will help him drive operational productivity within the company’s performance-driven culture. In conjunction with this appointment, Jackie Klecker has been named executive vice president, quality and development services, a newly created position which will take advantage of her leadership and strong regulatory compliance experience to maintain the company’s reputation for excellence in this area.

“As we continue to reshape Lifecore to best position the company to successfully execute on our ambitious growth strategy, we are incredibly fortunate to have two individuals as talented and experienced as Thomas and Jackie overseeing operations and quality. This organizational change strategically bifurcates the operations and quality functions, representing a natural evolution for Lifecore as we embark on our next phase of growth,” said Paul Josephs, president and chief executive officer of Lifecore. “With our capacity more than doubling through the recent installation of our new 5-head isolator filler, we believe it is essential that we dedicate sufficient focus and resources to our operations. Thomas’ recent leadership at a site that performed fermentation as well as fill/finish activities aligns well with Lifecore’s service offering. I’m confident that having a leader dedicated solely to our operations will help drive meaningful process efficiencies, strengthening our productivity.”

Mr. Josephs continued, “At the same time, as we plan for growth, we take our commitment to maintaining quality seriously. We look forward to leveraging Jackie’s operational knowledge as she shifts her focus to ensuring that our multi-compendial Quality Management System continues to evolve in response to new regulations, client needs, and an increased manufacturing footprint within our campus. Our team has worked diligently to achieve a strong, 40+ year regulatory track record as well as numerous global certifications and registrations. Having our quality activities overseen by a leader with a combination of broad organizational knowledge and deep technical experience, like Jackie, clearly acknowledges the vital importance we give to continuing to manufacture safe, high-quality products for our customers and their patients.”

Mr. Guldager brings 20 years of pharmaceutical industry experience to Lifecore, having managed, developed, and enhanced teams and organizations to drive performance through culture, accountability, and empathy. He most recently served as senior director, manufacturing and site leader for Xellia Pharmaceuticals, a specialty pharmaceutical company. A wholly owned subsidiary of Novo Holdings A/S, Xellia operates three state-of-the-art manufacturing facilities in Denmark, Hungary, and China. At Xellia, Mr. Guldager oversaw approximately 400 dedicated employees with responsibility for API manufacturing and fill/finish activities. During his more than 12 years with the company, he also held the positions of director of business excellence and director of operational excellence. His career has also included a tenure as chief operating officer of Vertanical, a Germany-based biopharmaceutical company, supply chain controller for ReckittBenckiser, a British-Dutch multinational consumer goods company, and a finance officer for GlaxoSmithKline. 

Ms. Klecker has more than 30 years of pharmaceutical industry experience focused on quality assurance, manufacturing, and development. She has been a member of the Lifecore team for more than 16 years, spanning two different tenures with the company. For the past decade, Ms. Klecker has been responsible for guiding quality assurance and regulatory affairs at Lifecore while also overseeing our operations. Prior to her new appointment as executive vice president, quality and development services, she held a series of key quality-focused positions of increasing responsibility, including general manager & executive vice president, senior director of quality assurance and regulatory affairs, and director of quality. Under her guidance, Lifecore has established an exceptional quality, regulatory and compliance track record, marked by the company’s world-class Quality Management System, operation of three cGMP manufacturing sites under regular inspection, and more than 40 years of successful interaction with global regulatory bodies.

About Lifecore Biomedical

Lifecore Biomedical, Inc. (Nasdaq: LFCR) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories to bring their innovations to market. For more information about the company, visit Lifecore’s website at www.lifecore.com.

Important Cautions Regarding Forward-Looking Statements

This press release contains forward-looking statements regarding future events and our future results that are subject to the safe harbor created under the Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act of 1933 and the Securities Exchange Act of 1934. Words such as “anticipate”, “estimate”, “expect”, “project”, “plan”, “intend”, “believe”, “may”, “might”, “will”, “should”, “can have”, “likely” and similar expressions are used to identify forward-looking statements. In addition, all statements regarding our anticipated future customer opportunities and relationships are forward-looking statements. All forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially, including such factors among others, as the company’s ability to successfully enact its business strategies, including with respect to installation, capacity generation and its ability to attract demand for its services, and its ability expand its relationship with its existing customers or attract new customers; the impact of inflation on the company’s business and financial condition;; changes in business conditions and general economic conditions both domestically and globally including rising interest rates and fluctuation in foreign currency exchange rates; the company’s ability to access to sufficient capital to fund its business strategies; and other risk factors set forth from time to time in the company’s SEC filings, including, but not limited to, the Annual Report on Form 10-K for the year ended May 26, 2024 (the “2024 10-K”). For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to our filings with the Securities and Exchange Commission, including the risk factors contained in the 2024 10-K. Forward-looking statements represent management’s current expectations as of the date hereof and are inherently uncertain. Except as required by law, we do not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances.

FAQ

Who is the new Vice President of Operations at Lifecore Biomedical (LFCR)?

Thomas Guldager has been appointed as Vice President of Operations at Lifecore Biomedical, bringing 20 years of pharmaceutical industry experience.

What recent capacity expansion has Lifecore Biomedical (LFCR) implemented?

Lifecore Biomedical has more than doubled its capacity through the recent installation of a new 5-head isolator filler.

What organizational changes has Lifecore Biomedical (LFCR) announced in November 2024?

Lifecore announced the separation of operations and quality functions, appointing Thomas Guldager as VP of Operations and Jackie Klecker as EVP of Quality and Development Services.

How long has Lifecore Biomedical (LFCR) maintained its regulatory track record?

Lifecore Biomedical has maintained a strong regulatory track record for more than 40 years, with successful interactions with global regulatory bodies.