Senior Specialist, Batch Disposition

Sr. Specialist, QA – Batch Disposition

Summary:

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.

The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.

The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.

Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

The Sr. Specialist, QA – Batch Disposition is responsible for providing Quality Assurance support for GMP documentation of master/working cell banks, bulk drug substance and finished drug product. Responsibilities include but are not limited to GMP documentation review and supporting other QA functions as needed. The Sr. Specialist, QA – Batch Disposition is responsible for continuously monitoring systems and procedures to ensure compliance with applicable regulatory and industry standards, and to identify areas of opportunity and quality improvements.

This is a full-time on-site position, Tues-Fri 8am-6pm

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:

• Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices (GDP), including but not limited to: executed batch records, master batch records, product labels, SMPs, and product specific documents
• Interacts with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging, and release of cell and gene therapy products
• Independently executes batch record review for completeness, accuracy and cGMP compliance
• Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product.
• Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs
• Compile and report performance metrics for Batch Review and Release
• Contributes to process improvement of batch records and associated processes (e.g. turnaround times) to ensure all QA batch disposition deadlines are met
• Ability to quickly process complex information and make critical decisions with limited information required
• Oversee status of batches through disposition/release process and remove barriers, communicate escalations as appropriate
• Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities
• Prepare reports and keep upper-level management informed of progress.
• Act as QA reviewer for investigations, deviations and CAPAs appropriate and designated by QA Management.
• Performs duties under limited supervision and according to standard operating and manufacturing procedures
• Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory
• Support on-the-floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.
• Perform tasks in a manner consistent with all Catalent policies including safety (EHS), quality systems and cGMP requirements
• Understand risks and delays to batch release and communicate appropriately
• Identify and participate in internal quality improvement initiatives: evaluate internal processes, suggest/design/ implement improvements, create/revise relevant SOPs
• Participate in site and corporate quality and process improvement initiatives. Represent QA on project teams and represent the Batch Disposition QA perspective as needed
• Actively participates in training activities, managing their individual training plan.
• Other duties as assigned.

The Candidate:

• Masters’ degree in a Scientific or Life Science discipline with 2 - 4 years’ experience biologic, biopharmaceutical, or regulated industry.

OR

• Bachelors’ degree in a Scientific or Life Science discipline with 4 - 6 years’ experience biologic, biopharmaceutical, or regulated industry.
• Proficient knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
• Proficient with biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.
• Ability to quickly learn new and novel manufacturing processes supporting new clients
• Able to work in a team setting and independently under minimum supervision
• Proficient with electronic systems, including developing and producing reports using Microsoft Office (Excel)
• Requires the ability to produce results in a fast-paced environment to meet client deadlines
• Proficient technical and quality background related to pharmaceuticals
• Able to effectively interpret new and existing global regulations
• Able to communicate effectively with all levels of personnel
• Clear problem-solving and decision-making skills
• Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
• Timeliness in completion of projects and paperwork (quantity of work)
• Accuracy in completion of projects and paperwork (quality of work)
• Contributions to projects beyond general responsibilities (quality of work)
• Identification of problem areas affecting operations (knowledge/problem solving)
• Offers suggestions for correcting problems and for improving operations
• Exercises good judgment in dealing with operational problems
• Understanding of theory, rationale behind tasks performed
• Ability to succeed in a team-oriented environment under very dynamic conditions
• Ability to be agile, adapt to change, and function well in an evolving environment
• Ability to succeed in a team-oriented environment under very dynamic conditions 

The anticipated salary range for this position in Maryland is $93,280- $128,260 plus shift differential and 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.

Position Benefits:

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
• 152 hours of paid time off annually + 8 paid holidays 
• Competitive salary with yearly bonus potential 
• Community engagement and green initiatives 
• Generous 401K match and Paid Time Off accrual 
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement

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. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers 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 DisabilityAccommodations@catalent.com. 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 HERE.