Supervisor, QC Microbiology

Company: Disability Solutions
Location: Severn
Posted on: September 28, 2024

Job Description:

Supervisor, QC MicrobiologyPosition SummaryCatalent 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 Supervisor, QC Microbiology is responsible for leading Microbiologists as well as overseeing the end-to-end contamination control and sterility assurance practices for Catalent's aseptic production process. This position will lead the following areas: Aseptic processing, cleaning and disinfection process, microbiological testing, environmental control and monitoring, and compliance to regulations and standard in the subject of sterility assurance and contamination control. The supervisor will be hands on and assist with execution of tasks if required.This position is 1st shift Monday-Friday and 100% on site at Harmans/BWI, Maryland facility. Position requires flexibility that may include off-hour, weekend, and holiday work.--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:----- Supervise the day-to-day operations in assigned area of the QC Microbiology department; provide guidance and expertise for Microbiological testing: Bioburden, Bacterial Endotoxin, Growth promotion, Microbial Identification, media fill/APS, method suitability, and Environmental/personnel monitoring.----- Ensure staff are fully trained on all cGMP manufacturing operations and documentation and are adhering to safety guidelines; --build effective teams that apply their diverse skills and perspectives to achieve common goals; oversee daily activity for the group to ensure quality results performance management for direct reports.-----Ensure Micro laboratory testing meets compliance requirements of the ISO, USP, EU, CFR, cGMP, and GLP; provide lead audit support during regulatory and customer audits; always maintain the Microbiology labs in a state of Audit Readiness; understand company goals and practices and apply them when resolving a variety of problems--- Perform review of Micro results for other Microbiologists, ensuring current results and report trends meet SOP and protocol requirements; communicate effectively with QC peers, cross-functional peers, and management; maintain training on QC Microbiology procedures (testing and environmental monitoring) to assist with hands on execution if required.----- Author and approve revision and creation of controlled documents such as Standard Operating Procedures and controlled forms. Author non-routine protocols/validation plans/reports in support of projects; lead troubleshooting and problem solving that may come up in the day-to-day operation of the department; lead investigations, change control, QCAs, CAPAs, and projects associated with Microbiological testing; lead data trending and tracking of results.----- Assist QC Managers and Supervisors with GMP and safety training of Quality Control staff; provide Microbiological instrumentation training to all new Microbiologists; provide training to all Microbiologists on new and existing revisions to laboratory methods and work instructions; effectively communicates results of own work and the team's work through discussions and documentation with some input from management; actively participates in training activities, managing individual and direct reports' training plans.------- Responsible for creating and maintaining direct reports' goals and development plans and administering performance review discussions; proactively partner with Human Resources to attract and retain top talent and take an active role in ensuring new employee onboarding is a success.----- Other duties as assigned by management.--The Candidate:--------- --Bachelor in a Microbiology, Biology, or related discipline with 8 - 10 years of experience working in a cGMP QC laboratory OR Masters in a Microbiology, Biology, or related discipline 6-8 years of experience working in a cGMP QC laboratory.--------- --2+ years Progressive Leadership experience in QC Micro and/or Aseptic manufacturing environment experience with Performance Management, Goal Setting, and Managing through Conflict.--------- --Strong experience working in cGMP Quality Control; experience in cGMP environment and experience with Quality Tools such as SPC and Root Cause Analysis, FMEA, 5 Whys, HACCP, and technical writing skills.--------- --Proficient in test method development and validation of microbiological or chemical test attributes; demonstrates strong scientific understanding of microbiological methods developments; demonstrated ability to investigate and identify causes of suspect laboratory results; strong knowledge of microbiological method development.--------- --Strong technical writing skills and use of Microsoft Office products; strong attention to detail and strong organizational skills; strong verbal communication skills with internal teams and outside clients and vendors; ability to succeed in a team-oriented environment under very dynamic conditions.--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--------- --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, Severn , Supervisor, QC Microbiology, Other , Severn, Maryland