Group Leader, Quality Control

Company: Disability Solutions
Location: Morrisville
Posted on: February 2, 2025

Job Description:

Position Summary:Catalent Pharma Solutions in Morrisville, NC is hiring a Group Leader for the Quality Control group. This position will serve as the primary subject matter expert (SME) and client liaison related to quality control activities supporting nasal and inhalation programs, while having supervisory responsibility for a team of 6-8 laboratory personnel. The Group Leader will plan, conduct, and supervise assignments involving the analytical testing for nasal and inhalation products from early phase programs to late phase programs. This position will also review progress and evaluate results, plan and assign personnel for given projects or tasks, recommend changes in procedures, and operate with substantial latitude for unreviewed action or decision all while complying with divisional and site Environmental Health and Safety requirements.This is a full-time position: Monday - Friday, 8:00AM - 5:00PM.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.The Research Triangle Park (RTP) facility is home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.----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

• Oversee all QC operations including raw material release, in process testing, release, and stability testing
• Responsible as technical lead on multiple projects, with responsibility for project outcome and customer interaction, including developing customer relationships to grow the business
• Responsible for oversight of Environmental Monitoring, clean utility monitoring, and compressed gas monitoring support for cGMP facility
• Supervise and coordinate activities of a team of Scientists, Senior Scientists, and/or Associates within the product development group.
• Oversee projects and maintain project timelines and budget
• Ensure that safe working practices are adopted in the laboratory and comply with in-house SOPs and other safety legislation
• Communicate effectively with both internal and external customers, peers, and supervising managers to facilitate the smooth conduct of project activities
• Ensure that appraisals and performance reviews are carried out in accordance with company policy and identify training needs of subordinates through discussion and with reference to the core competencies.
• Assure the integrity and quality of analytical data produced by ensuring staff are adhering to all relevant in-house and client SOPs and methodologies and following the requirements of GMP
• All other duties as assigned;The Candidate
  • Bachelors degree required in life sciences, including Chemistry, biochemistry, biology, microbiology, or a related physical science
  • Masters degree or PhD is preferred
  • Five or more years of relevant experience in the pharmaceutical industry and two or more years of managerial experience is required with a Bachelors degree or a Masters degree
  • With a PhD three or more years of relevant experience in the pharmaceutical industry and one or more years of managerial experience is required
  • Project management skills are required and routinely practiced for multiple concurrent projects of moderate to high complexity
  • Prior experience required in most aspects of drug development and lifecycle support for inhalation drug products, and must be able to develop useful strategies and tactics to meet regulatory milestones
  • Must be experienced and well versed in Method Validation requirements for Early phase and late phase products per ICH guidelines
  • Must have prior experience with USP and EP compendial methods; experience with JP is highly preferred
  • Strong knowledge and experience with a wide variety of analytical techniques such as HPLC, GC, FT-IR, UV/Vis, and Karl Fisher is required
  • Strong understanding of micro compendia including USP , , , Ph. Eur. 2.16.12/13 is strongly preferred
  • Prior experience or working knowledge with viable Air, Non-Viable Air, Surface Viable, and Water Sampling, Microbial Enumeration Testing, Conductivity, TOC, Air Viable, Microbial Enumeration Testing is preferred
  • Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;Why you should join Catalent:
    • Defined career path and annual performance review and feedback process--
    • Diverse, inclusive culture--
    • Positive working environment focusing on continually improving processes to remain innovative
    • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives--
    • 152 Hours + 8 paid holidays
    • Several Employee Resource Groups focusing on D&I
    • Dynamic, fast-paced work environment
    • Community engagement and green initiatives--
    • Generous 401K match--
    • Company match on donations to organizations
    • Medical, dental and vision benefits effective day one of employment--
    • Tuition Reimbursement--- Let us help you finish your degree or start a new degree!
    • WellHub program to promote overall physical wellness--
    • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categoriesCatalent 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 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 . 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 .

Keywords: Disability Solutions, Durham , Group Leader, Quality Control, Other , Morrisville, North Carolina