Group Lead, Technical Services

Group Lead, Central Services

Catalent Pharma Solutions is looking to hire a Group Lead , Central Services ( Day Shift) to support our Gene Therapy Team in Baltimore, MD.

Our Gene Therapy facility, located at the University of Maryland (UMD) BioPark in the city of Baltimore, MD, specializes in upstream and downstream process development of viral vectors for clinical applications. Baltimore is a hub of national and international travel and communications and is also home to and near major universities and several federal agencies, including the FDA, USDA, NIH, Johns Hopkins University, and UMD Schools of Medicine.

The facility houses process development labs and CGMP cleanroom suites for Phase 1 and 2 programs focused on a variety of transformative technologies, including AAV and other viral vectors, vaccines, and oncolytic immunotherapies.

The Technical Services (TS) department is responsible for supporting the execution of GMP manufacturing by ensuring the stocking of gowning inventory and the sterility of equipment and environment of the GMP Manufacturing Clean Rooms.

The Technical Services Group Lead will also be expected to adhere to all GMP standards and regulations to include quality requirements and documentation. The Technical Services Group Lead is a working lead responsible for daily execution of the operations schedule to deliver the desired output in a safe, compliant, and efficient manner. The Group Lead has broad knowledge of aseptic cleaning technique, theories and principles, demonstrates systematic problem-solving skills, and integrates continuous improvement into the larger manufacturing organization guided by The Catalent Way.

This position will take place on the day shift, Monday - Friday, 8am-5pm.

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

• Perform the day-to-day operations in assigned area of the GMP areas.

• Assist in Coordinating, with indirect supervisory responsibilities, GMP Cleaning activities for a group of Tech Services Technicians.

• Assign tasks and provide guidance to employees according to established policies and management guidance.

• Practices operational excellence methodologies in The Catalent Way and acts as a change agent for continuous improvement efforts. Leads tier 1 meetings in the review and execution of people, safety, quality, delivery, and cost objectives.

• Assists the supervisor with rapid response and problem resolution for daily issues and in Overseeing the daily activity for the group to ensure quality results and Performance management for direct reports.

• Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines.

• Provide thorough review / input of documents (SOP's, SMP's, Protocols...).

• Assist in initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs.

• Troubleshoot process and equipment problems.

• Ensure gowning areas into and within Manufacturing areas are constantly stocked with supplies.

• Assist Central Services Technicians in other day-to-day duties but not limited to: Equipment Wash Room / Parts Washer; Equipment & Parts Sterilization / Autoclave; WFI Port Flushing; Filter Integrity Testing; Monitor supply inventory; Room Wash Down / Turn-over

• Perform other related duties as assigned to meet departmental and Company objectives.

The Candidate

• HS Diploma or GED required with a minimum of 4 years of experience in GMP production organization.

• Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks.

• Demonstrates daily focus on safe behaviors and adept at recognizing unsafe conditions.

• Thorough understanding of quality systems in regulated environment and fully committed to right first time (RFT) execution.

• Excellent documentation skills including comprehension, review & establishing SOP's, deviation & summary reports.

• Proficient knowledge and ability to apply scientific principles utilized to solve operational, as well as routine production tasks and possesses proficient equipment understanding, including understanding equipment function and application.

• Leads by example, keeping in mind organizational values, policies and goals. Develops people and team coaching and collaboration and must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).

• Strong communication skills Proficient in MS Office and related PC skills.

• Must be able to lift up to 25lbs minimum

• Ability to work in a lean, action-oriented organization and demonstrate a strong work ethic.

• Actively pursues learning of required skills, new skills, and new equipment.

• Must have the ability to work an available set shift; there will be times when overtime is required.

The anticipated salary range for this position in Maryland is $71,000 to $95,000 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.

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

• 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 ~~~ . 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.

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