Associate Director, Manufacturing Operations
Associate Director, Manufacturing OperationsCatalent Cell and Gene Therapy is looking to recruit an Associate Director, Manufacturing Operations to join our growing team in Baltimore, MD.
The Associate Director, Manufacturing Operations is accountable for leading teams to execute procedures for Drug Substance production, solution prep, and support the cleaning functions of manufacturing using SOP and batch records.
Provide hands-on direction for Drug Substance production, and GMP manufacturing activities.
This position requires extensive technical expertise in aseptic techniques and filling.
Provide expertise in writing/reviewing SOPs, Batch Records, Deviations, CAPAS, and other technical document/compliance documents as it relates to the Biologic Operations.
Serves as a custodian of building operations including facilities, utilities, and the maintenance oversight of the areas applicable for Catalent's GMP operations.
Catalent hires people with a passion to make a difference.
Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech, and healthcare companies, will help bring life-enhancing products to the people you know and love.
Your talents, ideas, and passion are essential to our mission; to develop, manufacture, and supply products that help people live better healthier lives.
The Role Manage the day-to-day operations in the assigned area of the Contract Manufacturing Facility.
Ensure staff is fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines.
Lead initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs.
Oversee and schedule drug substance, compounding and filling operations and personnel within cGMP guidelines to produce pure, safe, and effective products.
Responsible for training manufacturing personnel on the use of Batch records, scheduling, ordering of raw materials, components, and supplies fill, setting up production batches, and maintaining buffer inventory.
Responsible for writing/reviewing drug substance, compounding, filling, and packaging batch records, reviewing SOPs pertaining to compounding, filling, and packaging processes and equipment, and writing/reviewing preparation for the ordering and receiving of equipment to be used in the compounding, filling, and packaging process.
Work with Manufacturing, Quality, Engineering, and Technology groups on issues and identifies process improvement opportunities.
Will interact with the Analytical Development (AD) and Process Development (PD) teams as it pertains to operational activities.
Ensure the compliance and regulatory state of the facility and operations is in compliance at all times.
Serve as an escalation point for operations and facilities.
Responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating performance and rewarding as appropriate, disciplining and recommending termination when necessary.
Identify and support the implementation of process efficiencies and areas for improvement.
Proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding is a success.
Other duties as assigned.
The Candidate Master's degree in a Scientific, Engineering, or Biotech field with a minimum of 5 years of experience under GMP compliance preferred OR Bachelor's degree in a Scientific, Engineering, or Biotech field with a minimum of 7 years of experience under GMP compliance preferred OR HS Diploma or Associate Degree with a minimum of 10 years of experience under GMP compliance preferred.
Candidate must have a minimum of 5 years' experience with Biologic production processes.
2 - 4 Progressive Leadership experience, experience with Performance Management, Goal Setting, and Managing through Conflict.
Expert knowledge and ability to work in, train for, or have practical knowledge of clean room/aseptic environment operations.
Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records, SOPs, deviation & summary reports.
Possesses proficient equipment understanding, including an understanding of equipment function and application.
Creative thinking with the ability to multi-task Solid communication skills across technical and non-technical audiences and the ability to create and communicate complex concepts and analyses in easy-to-understand ways.
Why You Should Join Catalent Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Defined career path and annual performance review & feedback process Cross-functional exposure to other areas within the organization Medical, Dental, Vision, and 401K are all offered from day one of employment Employee Stock Purchase Plan 19 days PTO and 8 paid holidays 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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve.
As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety.
The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
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 email protected .
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 email protected for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Recommended Skills Asepsis Biotechnology Business Process Improvement Cleanrooms Creativity Human Resources Estimated Salary: $20 to $28 per hour based on qualifications.
The Associate Director, Manufacturing Operations is accountable for leading teams to execute procedures for Drug Substance production, solution prep, and support the cleaning functions of manufacturing using SOP and batch records.
Provide hands-on direction for Drug Substance production, and GMP manufacturing activities.
This position requires extensive technical expertise in aseptic techniques and filling.
Provide expertise in writing/reviewing SOPs, Batch Records, Deviations, CAPAS, and other technical document/compliance documents as it relates to the Biologic Operations.
Serves as a custodian of building operations including facilities, utilities, and the maintenance oversight of the areas applicable for Catalent's GMP operations.
Catalent hires people with a passion to make a difference.
Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech, and healthcare companies, will help bring life-enhancing products to the people you know and love.
Your talents, ideas, and passion are essential to our mission; to develop, manufacture, and supply products that help people live better healthier lives.
The Role Manage the day-to-day operations in the assigned area of the Contract Manufacturing Facility.
Ensure staff is fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines.
Lead initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs.
Oversee and schedule drug substance, compounding and filling operations and personnel within cGMP guidelines to produce pure, safe, and effective products.
Responsible for training manufacturing personnel on the use of Batch records, scheduling, ordering of raw materials, components, and supplies fill, setting up production batches, and maintaining buffer inventory.
Responsible for writing/reviewing drug substance, compounding, filling, and packaging batch records, reviewing SOPs pertaining to compounding, filling, and packaging processes and equipment, and writing/reviewing preparation for the ordering and receiving of equipment to be used in the compounding, filling, and packaging process.
Work with Manufacturing, Quality, Engineering, and Technology groups on issues and identifies process improvement opportunities.
Will interact with the Analytical Development (AD) and Process Development (PD) teams as it pertains to operational activities.
Ensure the compliance and regulatory state of the facility and operations is in compliance at all times.
Serve as an escalation point for operations and facilities.
Responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating performance and rewarding as appropriate, disciplining and recommending termination when necessary.
Identify and support the implementation of process efficiencies and areas for improvement.
Proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding is a success.
Other duties as assigned.
The Candidate Master's degree in a Scientific, Engineering, or Biotech field with a minimum of 5 years of experience under GMP compliance preferred OR Bachelor's degree in a Scientific, Engineering, or Biotech field with a minimum of 7 years of experience under GMP compliance preferred OR HS Diploma or Associate Degree with a minimum of 10 years of experience under GMP compliance preferred.
Candidate must have a minimum of 5 years' experience with Biologic production processes.
2 - 4 Progressive Leadership experience, experience with Performance Management, Goal Setting, and Managing through Conflict.
Expert knowledge and ability to work in, train for, or have practical knowledge of clean room/aseptic environment operations.
Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records, SOPs, deviation & summary reports.
Possesses proficient equipment understanding, including an understanding of equipment function and application.
Creative thinking with the ability to multi-task Solid communication skills across technical and non-technical audiences and the ability to create and communicate complex concepts and analyses in easy-to-understand ways.
Why You Should Join Catalent Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Defined career path and annual performance review & feedback process Cross-functional exposure to other areas within the organization Medical, Dental, Vision, and 401K are all offered from day one of employment Employee Stock Purchase Plan 19 days PTO and 8 paid holidays 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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve.
As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety.
The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
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 email protected .
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 email protected for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Recommended Skills Asepsis Biotechnology Business Process Improvement Cleanrooms Creativity Human Resources Estimated Salary: $20 to $28 per hour based on qualifications.
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