Lead Specialist, Client QA
Position Summary: Work Schedule: Monday Friday, 8am 5pm. 100% on-site Catalent is a leading global CDMO partnering with pharma and biotech innovators to accelerate development and delivery of life-changing therapies. Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MDjust minutes from BWI Airportfeatures EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through commercial production of advanced therapies, including AAV and other viral vector-based products. The Lead Specialist, QA is responsible for providing QA lead support and oversight of Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product. You'll play a key role in ensuring the quality and compliance of cutting-edge gene therapy products. Acting as the dedicated Client QA Representative, you'll oversee projects from start to finishpartnering with cross-functional teams in Manufacturing, Process Development, Technology Transfer, and Quality Control. Your work will include reviewing and tracking critical GMP documentation such as technology transfer records, specifications, master batch records, and investigations, all supporting the release of life-changing therapies. This is an opportunity to make a direct impact on patient health while collaborating in a dynamic, growth-driven environment. The Role
Provide dedicated QA support for client projects and client interactions, serving as the primary QA contact throughout the project lifecycle. Provides quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product. Support clinical and commercial QA activities from process development through non-clinical and commercial production. Track and present key quality metrics for client projects, including batch release timelines and deviation trends. Collaborate with clients during initial and subsequent manufacturing campaigns to ensure compliance and quality standards. Review and approve master batch records during technology transfer for client processes. Support GMP departments in reviewing and approving deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and evaluating effective corrective and preventive actions (CAPAs) Perform risk assessments and mitigation strategies using tools such as FMEA. Maintain and update systems and databases for tracking manufacturing and quality activities. Support audits and inspections by regulatory agencies and clients and assist with internal GMP audits. Other duties as assigned. The Candidate
Masters' degree in a Scientific, Engineering or Biotech field with a minimum of 4 years' experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry OR Bachelor's degree in a Scientific, Engineering or Biotech field with a minimum of 6 years' experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry. Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs. Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish. Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, Master Control and Trackwise knowledge preferred. Creative individual with strong analytical, troubleshooting, and decision-making skills to resolve complex issues effectively. Ability to quickly learn new and novel manufacturing processes supporting new clients. Proven ability to work independently and in cross-functional teams, delivering high-quality results in a fast-paced, deadline-driven environment while meeting client and regulatory requirements. The anticipated salary range for this position in Maryland is $120,000 to $150,000 plus an 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. Why You Should Join Catalent
Potential for career growth within an expanding team. Defined career path and annual performance review & feedback process. Cross-functional exposure to other areas within the organization. Medical, Dental, Vision, and 401K are all offered from day one of employment. 152 hours of PTO and 8 paid holidays. Opportunity to work on Continuous Improvement Processes 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.
Position Summary: Work Schedule: Monday Friday, 8am 5pm. 100% on-site Catalent is a leading global CDMO partnering with pharma and biotech innovators to accelerate development and delivery of life-changing therapies. Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MDjust minutes from BWI Airportfeatures EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through commercial production of advanced therapies, including AAV and other viral vector-based products. The Lead Specialist, QA is responsible for providing QA lead support and oversight of Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product. You'll play a key role in ensuring the quality and compliance of cutting-edge gene therapy products. Acting as the dedicated Client QA Representative, you'll oversee projects from start to finishpartnering with cross-functional teams in Manufacturing, Process Development, Technology Transfer, and Quality Control. Your work will include reviewing and tracking critical GMP documentation such as technology transfer records, specifications, master batch records, and investigations, all supporting the release of life-changing therapies. This is an opportunity to make a direct impact on patient health while collaborating in a dynamic, growth-driven environment. The Role
Provide dedicated QA support for client projects and client interactions, serving as the primary QA contact throughout the project lifecycle. Provides quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product. Support clinical and commercial QA activities from process development through non-clinical and commercial production. Track and present key quality metrics for client projects, including batch release timelines and deviation trends. Collaborate with clients during initial and subsequent manufacturing campaigns to ensure compliance and quality standards. Review and approve master batch records during technology transfer for client processes. Support GMP departments in reviewing and approving deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and evaluating effective corrective and preventive actions (CAPAs) Perform risk assessments and mitigation strategies using tools such as FMEA. Maintain and update systems and databases for tracking manufacturing and quality activities. Support audits and inspections by regulatory agencies and clients and assist with internal GMP audits. Other duties as assigned. The Candidate
Masters' degree in a Scientific, Engineering or Biotech field with a minimum of 4 years' experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry OR Bachelor's degree in a Scientific, Engineering or Biotech field with a minimum of 6 years' experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry. Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs. Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish. Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, Master Control and Trackwise knowledge preferred. Creative individual with strong analytical, troubleshooting, and decision-making skills to resolve complex issues effectively. Ability to quickly learn new and novel manufacturing processes supporting new clients. Proven ability to work independently and in cross-functional teams, delivering high-quality results in a fast-paced, deadline-driven environment while meeting client and regulatory requirements. The anticipated salary range for this position in Maryland is $120,000 to $150,000 plus an 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. Why You Should Join Catalent
Potential for career growth within an expanding team. Defined career path and annual performance review & feedback process. Cross-functional exposure to other areas within the organization. Medical, Dental, Vision, and 401K are all offered from day one of employment. 152 hours of PTO and 8 paid holidays. Opportunity to work on Continuous Improvement Processes 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.