3rd Party Technical Operations Manager
Description Position at The O'Connor Group Amring Pharmaceuticals sells uniquely positioned and harder-to-manufacture generics that bring value to customers and patients.
Amring spends every minute of every day figuring out how to bring historically complex prescription medications to market.
Amring's products are generics of value to the market, not high-volume, mass-produced products.
The CMO/Technical Project Manager role will interface with Amring's CMOs while collaborating with our internal supply team to ensure commercial product supply.
This role requires excellent interpersonal skills, the ability to influence outcomes, strong technical and project management skills related to manufacturing/packaging of pharmaceutical products.
This position will require extensive collaboration with CMOs and 3rd party suppliers and responsibility for scale-up, technology transfer, process optimization and general marketed product support.
The successful applicant will possess the following attributes:
integrity, self-directed, innovative, highly motivated to succeed, results oriented, a high level of ownership, sense of urgency and accountability.
Responsibilities:
1.
Oversight of Amring's CMO relationships including product manufacturing, on time deliveries and managing technical projects.
2.
Directly involved with all aspects of project management for assigned projects.
3.
Process improvements and cost reduction initiatives to existing marketed products/processes.
4.
Collaboration with Amring Product Development and CMOs regarding scale-up of manufacturing processes and technology transfer strategies.
5.
Lead technology transfer and process validation efforts.
6.
Ensure the manufacturability of new products as they advance through the development process.
7.
Provide technical support for new product launches and all marketed products.
8.
Write and/or review protocols, batch records, standard operating procedures and other technical reports to support technology transfer activities, process validations, API qualifications and other documents as required.
9.
Participate in the process optimization and in the scale-up or manufacture of drug products.
10.
Lead project teams, interact with peers including supply chain, QA/RA, R&D and third-party manufacturers to advance projects in a timely and cost-effective way while maintaining quality.
11.
Successfully develop and execute technology transfer strategies including project plans, protocols, and transfer of manufacturing processes into cGMP drug product manufacturing facility(ies).
12.
Provide technical expertise to CMOs related to manufacturing processes.
13.
Interact closely with the contract manufacturer to achieve specified objectives.
Uses metrics to measure and track CMO performance.
Responsible for resolving issues with CDMOs.
14.
Assesses manufacturing requirements and capabilities prior to the transfer of new processes to the manufacturing site; prepare process transfer documentation and lead technology transfer efforts.
15.
Travel 10-20% domestic and international.
REQUIREMENTS:
1.
Must have a Bachelor's Degree in Chemical Engineering, Pharmaceutical Sciences or related discipline with 7-10 years of relevant process engineering and CMO management experience.
2.
Significant experience working with third party service providers (CDMOs, API suppliers, Contract Labs, etc).
3.
Strong interpersonal skills and ability to influence outcomes with third party service providers.
4.
Experience with troubleshooting and problem solving of sterile products in a production environment.
5.
Experience in process development, process optimization and scale-up of parenteral and solid dosage forms.
6.
Knowledge in pharmaceutical technology and manufacturing, CMC regulatory requirements, project management; and capability to collaborate closely with both internal and external stake holders.
7.
Knowledge of practices and equipment in a GMP manufacturing environment, including closed-systems, single-use/disposable technology, and sterile/aseptic processing.
8.
Experience with Technical Agreements, Supply Agreements and Services Agreements.
9.
Application of advanced automation and statistical data analysis, including design of experiments is desired.
10.
Experience working in a GMP regulated environment.
Knowledge of cGMPs and an understanding of the concepts of GLP, GCP and FDA guidelines.
11.
Experienced in aseptic/sterile processing.
12.
Ability to work with minimal supervision and perform operational tasks independently.
13.
Strong verbal and written communication skills and interpersonal skills.
14.
Strong technical and problem-solving skills.
15.
Strong project management skills with the ability to drive projects on time and on budget.
16.
Results oriented individual driven to succeed.
17.
Highly motivated and driven to acquire new skills.
Recommended Skills Api Automation Chemical Engineering Communication Design Of Experiments Innovation Estimated Salary: $20 to $28 per hour based on qualifications.
Amring spends every minute of every day figuring out how to bring historically complex prescription medications to market.
Amring's products are generics of value to the market, not high-volume, mass-produced products.
The CMO/Technical Project Manager role will interface with Amring's CMOs while collaborating with our internal supply team to ensure commercial product supply.
This role requires excellent interpersonal skills, the ability to influence outcomes, strong technical and project management skills related to manufacturing/packaging of pharmaceutical products.
This position will require extensive collaboration with CMOs and 3rd party suppliers and responsibility for scale-up, technology transfer, process optimization and general marketed product support.
The successful applicant will possess the following attributes:
integrity, self-directed, innovative, highly motivated to succeed, results oriented, a high level of ownership, sense of urgency and accountability.
Responsibilities:
1.
Oversight of Amring's CMO relationships including product manufacturing, on time deliveries and managing technical projects.
2.
Directly involved with all aspects of project management for assigned projects.
3.
Process improvements and cost reduction initiatives to existing marketed products/processes.
4.
Collaboration with Amring Product Development and CMOs regarding scale-up of manufacturing processes and technology transfer strategies.
5.
Lead technology transfer and process validation efforts.
6.
Ensure the manufacturability of new products as they advance through the development process.
7.
Provide technical support for new product launches and all marketed products.
8.
Write and/or review protocols, batch records, standard operating procedures and other technical reports to support technology transfer activities, process validations, API qualifications and other documents as required.
9.
Participate in the process optimization and in the scale-up or manufacture of drug products.
10.
Lead project teams, interact with peers including supply chain, QA/RA, R&D and third-party manufacturers to advance projects in a timely and cost-effective way while maintaining quality.
11.
Successfully develop and execute technology transfer strategies including project plans, protocols, and transfer of manufacturing processes into cGMP drug product manufacturing facility(ies).
12.
Provide technical expertise to CMOs related to manufacturing processes.
13.
Interact closely with the contract manufacturer to achieve specified objectives.
Uses metrics to measure and track CMO performance.
Responsible for resolving issues with CDMOs.
14.
Assesses manufacturing requirements and capabilities prior to the transfer of new processes to the manufacturing site; prepare process transfer documentation and lead technology transfer efforts.
15.
Travel 10-20% domestic and international.
REQUIREMENTS:
1.
Must have a Bachelor's Degree in Chemical Engineering, Pharmaceutical Sciences or related discipline with 7-10 years of relevant process engineering and CMO management experience.
2.
Significant experience working with third party service providers (CDMOs, API suppliers, Contract Labs, etc).
3.
Strong interpersonal skills and ability to influence outcomes with third party service providers.
4.
Experience with troubleshooting and problem solving of sterile products in a production environment.
5.
Experience in process development, process optimization and scale-up of parenteral and solid dosage forms.
6.
Knowledge in pharmaceutical technology and manufacturing, CMC regulatory requirements, project management; and capability to collaborate closely with both internal and external stake holders.
7.
Knowledge of practices and equipment in a GMP manufacturing environment, including closed-systems, single-use/disposable technology, and sterile/aseptic processing.
8.
Experience with Technical Agreements, Supply Agreements and Services Agreements.
9.
Application of advanced automation and statistical data analysis, including design of experiments is desired.
10.
Experience working in a GMP regulated environment.
Knowledge of cGMPs and an understanding of the concepts of GLP, GCP and FDA guidelines.
11.
Experienced in aseptic/sterile processing.
12.
Ability to work with minimal supervision and perform operational tasks independently.
13.
Strong verbal and written communication skills and interpersonal skills.
14.
Strong technical and problem-solving skills.
15.
Strong project management skills with the ability to drive projects on time and on budget.
16.
Results oriented individual driven to succeed.
17.
Highly motivated and driven to acquire new skills.
Recommended Skills Api Automation Chemical Engineering Communication Design Of Experiments Innovation Estimated Salary: $20 to $28 per hour based on qualifications.
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