Catalent Inc
Group Lead - Central Services
Catalent Inc, Baltimore, Maryland, United States, 21276
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 Central Services (CS) department is responsible for the execution of clinical and commercial standard manufacturing process (SMP). The buffers and media prepped by CS are used for solution preparation, master/working cell bank production, upstream cell culture and viral vector production, downstream purification, and fill/finish operations. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.
The Central 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 solution preparation 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
Performs daily production activities to ensure schedule adherence.
Coordinates, with indirect supervisory responsibilities, production activities for a group of Manufacturing Associates / Technicians.
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. .
Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines and assists the supervisor with rapid response and problem resolution for daily issues.
Completes SMPs under cGMP, and documents in detail using SOPs and SMPs for the processes and manufacturing steps. Generate and revise internal and external documents (SOPs, SMPs).
Support 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; Work with Facilities and Validation to maintain manufacturing equipment. Recommend equipment and other supply purchases within the production areas.
Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays. May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP production.
Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns.
Participate in facility expansion and equipment validation activities.
Other duties as assigned
The Candidate
Bachelor's or Master’s degree in technical discipline (e.g., biology, biotechnology, engineering) or related life science field with minimum of 2 years’ related experience
OR
Associate’s degree in technical discipline (e.g., biology, biotechnology, engineering) or related life science field with minimum of 4 years’ related experience
OR
High School Diploma with minimum of 6 years’ related experience.
Experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance required.
Thorough knowledge of current Good Manufacturing Practices (cGMP’s), and all relevant safety procedures. General understanding of most areas in Manufacturing and supporting functional groups.
Thorough understanding of quality systems in a regulated environment and fully committed to right first time (RFT) execution. Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks.
Excellent documentation skills including comprehension, review & establishing SMPs, or Batch Production Records, SOP’s, deviation & summary reports required.
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 $75,000 to $100,000 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 (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) .
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 Central Services (CS) department is responsible for the execution of clinical and commercial standard manufacturing process (SMP). The buffers and media prepped by CS are used for solution preparation, master/working cell bank production, upstream cell culture and viral vector production, downstream purification, and fill/finish operations. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.
The Central 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 solution preparation 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
Performs daily production activities to ensure schedule adherence.
Coordinates, with indirect supervisory responsibilities, production activities for a group of Manufacturing Associates / Technicians.
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. .
Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines and assists the supervisor with rapid response and problem resolution for daily issues.
Completes SMPs under cGMP, and documents in detail using SOPs and SMPs for the processes and manufacturing steps. Generate and revise internal and external documents (SOPs, SMPs).
Support 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; Work with Facilities and Validation to maintain manufacturing equipment. Recommend equipment and other supply purchases within the production areas.
Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays. May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP production.
Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns.
Participate in facility expansion and equipment validation activities.
Other duties as assigned
The Candidate
Bachelor's or Master’s degree in technical discipline (e.g., biology, biotechnology, engineering) or related life science field with minimum of 2 years’ related experience
OR
Associate’s degree in technical discipline (e.g., biology, biotechnology, engineering) or related life science field with minimum of 4 years’ related experience
OR
High School Diploma with minimum of 6 years’ related experience.
Experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance required.
Thorough knowledge of current Good Manufacturing Practices (cGMP’s), and all relevant safety procedures. General understanding of most areas in Manufacturing and supporting functional groups.
Thorough understanding of quality systems in a regulated environment and fully committed to right first time (RFT) execution. Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks.
Excellent documentation skills including comprehension, review & establishing SMPs, or Batch Production Records, SOP’s, deviation & summary reports required.
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 $75,000 to $100,000 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 (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) .