Senior Specialist, QA Analytical

Position Summary

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

Catalent’s Harmans/BWI, MD facility is a FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The campus features two manufacturing facilities: 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 Senior Specialist, QA Analytical is responsible for providing QA support to the Analytical Development and Quality Control departments of our Contract Manufacturing Organization, performing analytical method development and review of data generated as part of in-process, release and stability testing of biopharmaceuticals.

This position is 1st shift M-F 8AM-5PM and 100% on site at Harmans/BWI, Maryland facility.

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:

• Maintain and administer quality systems including document management, investigation/deviations, CAPA tracking, risk management, quality metric tracking, training and other quality systems.

• Interface and communicate with the Client, Analytical Development teams, Method Services group and the Quality Control departments in meeting project timelines, providing deliverables and resolving issues; implement continuous improvement initiatives.

• Perform quality review of documentation including raw data, test methods, protocols and executed method qualification/transfer/verification/validation reports.

• Support external client audits; perform periodic walk-through audits of Analytical Development and Quality Control laboratories; Support regulatory (FDA, EMA) and client audits/inspections of Catalent.

• Provide quality oversight of process and analytical method development in an R&D setting for client projects; provide quality oversight in compliance with GMPs for Quality Control testing of clinical product.

• Support the Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution; support the CAPA Tracking System and track the timely completion and extension of commitments.

• Generate, revise, and review Pre-Clinical Services Standard Operating Procedures (SOPs), Standard Test Method (STM) and other documentation as needed; maintain databases and systems used for tracking various activities.

• Continually evaluate systems and procedures for improvement for efficiency and compliance to applicable regulatory requirements and standards; Work independently under general supervision to meet company goals; actively participates in training activities, managing their individual training plan.

• Other duties as assigned

The Candidate :

• Masters’ degree in a Scientific, Engineering or Biotech field with 2 – 4 years’ experience Quality Assurance/Quality Control function reviewing Analytical testing for analytical assays such as ELISA, DDPCR, HPLC, SDS-PAGE, Western blot OR as an Analytical Chemist with some documentation review OR Bachelor’s degree in a Scientific, Engineering or Biotech field with 4-6 years’ experience Quality Assurance/Quality Control function reviewing Analytical testing data for analytical assays such as ELISA, DDPCR, HPLC, SDS-PAGE, Western blot OR as an Analytical Chemist with some documentation review.

• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines; Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.

• Familiarity with biological assay and method development (i.e. ELISA, HPLC, ddPCR, Western Blot, qPCR, etc) a plus

• Exposure to Lean Operational Excellence highly desirable.

• Ability to work in a lean, action-oriented organization and demonstrate a strong work ethic; must be flexible, adaptable, self-motivated, and able to work well independently and across teams and partners;

• Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups); actively pursues learning of required skills, new skills, and new equipment.

• Proficient in MS Office and related PC skills

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• Dynamic, fast-paced work environment

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

• Wellhub program to promote overall physical wellness

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 (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .