API Manufacturing Science & Technology Manager (m/w/d)

Mumbai, Maharashtra Elanco

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Job Description

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Elanco Animal Health, is a global research-based company that develops and markets products to improve the health and production of animals in more than 100 countries. Elanco products enhance animal health, wellness, welfare, and performance to help the food industry produce an abundant supply of safe and affordable food. Elanco Companion Animal is the source of product innovations that enable veterinarians to help pets live longer, healthier, higher quality lives.

Elanco External Manufacturing (EEM) is the virtual manufacturing plant for Elanco Animal Health. Therefore, contract manufacturers produce all EEM API and drug products. The purpose of this Manufacturing Science& Technology Manager (MS&T, internally named Technical Services / Manufacturing Science TS/MS at Elanco) position is to provide technical support and oversight for established products managed by the EEM Global API Hub, ensuring a reliable supply of quality products at minimum cost. 

This TS/MS position partners with Quality, Operations, supply chain, and R&D throughout the commercial launch and lifecycle manufacture of various active intermediates/APIs, and collaborate with relevant functions from internal and external drug product manufacturing sites. This position focuses on ensuring a robust API manufacturing process capable of supplying market demand, and it includes a wide variety of project assignments and work experiences. This position assists with the impact assessment and implementation of manufacturing changes of API encompassing validation activities, creating supporting information for Regulatory submissions and interactions with Elanco finished product manufacturing sites.

Functions, Duties, Tasks:

API commercial Manufacturing

  • Serve as primary technical resource for assigned API processes and their impact on finished product sites
  • Provide technical support for responsible API manufacturing activities and maintain appropriate manufacturing presence (person in plant) when required.
  • Lead tech transfer, process implementation, and process validation activities.
  • Technical review of manufacturing documents for EEM governance (MBRs/eBRs, PQRs, Validation, Deviations, Stability, Manufacturing reviews, Metrics Dashboard reporting).
  • Identify, evaluate, and implement process improvements with a focus on capability, compliance, and cost and regulatory impact.
  • Review process and product data for adverse trends; assess and understand process capability, CAPA planning and implementation to mitigate associated risks.
  • Author technical/manufacturing documents (Change Controls, Process Flow Documentation/PFDs, Annual Product Quality reviews (aPQRs), Registration supporting reports) as needed.
  • Cross Functional support

  • Work across internal and external sites with cross-functional groups to troubleshoot issues with intermediate, API and Drug Product manufacturing, including but not limited to deviations
  • Support the commercialization of new products by partnering with R&D colleagues in the later phase of the development process; Ensure manufacturing concerns are addressed at phase-appropriate points of development; effectively apply principles of QbD as applicable
  • Support the identification, selection, and approval of contract manufacturers with a focus on technical support for API RFP processes including preparation of Tech Package.
  • Significant Regulatory support for many API (and DP) registration revisions; Support geo-expansion launches in secondary markets, ensuring regulatory commitments are aligned with process capabilities
  • Knowledge Mentoring with many cross-functional EEM team members assisting colleague transitions (QC/QA, Reg CMC, Operations, Supply Chain, DP teams/sites)
  • Minimum Qualification (education, experience and/or training, required certifications):

  • Bachelors of Science degree in Chemistry or Chemical Engineering with research/development/manufacturing work experience.
  • Prior relevant API manufacturing experience (minimum 5 years)
  • Understanding of cGMP requirements for drug substance and drug product manufacturing.
  • Strong problem-solving skills, including facilitation, strategic and creative thinking.
  • Strong interpersonal skills for stakeholder management.
  • Clear, concise and proactive communication skills (both written and verbal)
  • Cross-functional networking skills: demonstrated ability to influence others.
  • Strong analytical skills.
  • Ability to handle multiple priorities and deal with ambiguity.
  • Computer literacy.
  • Demonstrated ability to achieve results with people
  • Additional Preferences:

  • PhD degree in Chemistry or Chemical Engineering
  • API process development, TechTransfer, process validation, and product commercialization experience.
  • Understanding of and experience in multiple technology platforms (small molecule, large molecule, material science, chemical engineering, oral solid dose, premixes etc.)
  • Prior experience driving continuous improvement, leading change and deviation management
  • Understanding of regulatory requirements (, EDQM, CVM) and ability to create Regulatory support documents (Reports and Comparability Protocols).
  • Knowledge of statistical methods and applicable software ( JMP, minitab etc).
  • Understanding of analytical methods.
  • Working knowledge of quality document management system ( Veeva).
  • Working knowledge of AI tools related to task management, technical writing etc.
  • Other Information:
  • Approximately 15-25% travel to global contract manufacturing sites supporting commercial oversight, project delivery and technical Due Diligence activities.
  • What we offer

  • Work Environment : international, open and inclusive environment
  • Compensation & Benefits : competitive compensation package with variable element, attractive health insurance benefit and pension fund solution, recognition platform
  • Wellbeing : free annual voluntary health check, Employee Assistance Program, fruits
  • Time : five bridging days in addition to vacation entitlement, flexible working hours
  • Healthy Purpose : Elanco offers in total three full days of volunteering per year to join local charities and communities to make a positive impact and give back to the community
  • This advertiser has chosen not to accept applicants from your region.

    Production Engineer

    Mumbai, Maharashtra Snaphunt

    Posted today

    Job Viewed

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    Job Description

    The Offer

    • Attractive Salary & Benefits
    • Join a well known brand within Manufacturing
    • Work in a company with a solid track record of performance

    The Job

    You will be responsible for :

    • Managing the day to day production activities and ensuring that the production shopfloor and workstations are running smoothly and cost effectively.
    • Promoting operational excellence and production of high-quality products.
    • Liaising with different teams across the plant to ensure goals and objectives are met.
    • Driving continuous improvement regarding line efficiency by periodically reviewing performance results of production lines and taking corrective actions as necessary.
    • Ensuring health and safety guidelines are followed.
    • Reviewing worker performance and implementing coaching and training as required.
    • Managing a team of 50-100 people.

    The Profile

    • You have at least 5 years experience including solid experience in a similar role within Industrial.
    • You possess excellent communication and influencing skills, are organised and able to multi-task effectively.
    • You have working knowledge of diploma in mechanical engneer
    • You are highly goal driven and work well in fast paced environments
    • You possess strong analytical skills and are comfortable dealing with numerical data
    • You pay strong attention to detail and deliver work that is of a high standard
    • You are willing to undertake 30-60% travel.

    The Employer

    Our client was established in the year 1982 at MUMBAI, with Erection and commissioning of Hydraulic systems as prime objective. Company is under able control of Technocrats having decades of association with the Pioneers in Oil Hydraulic industry in INDIA today.

    This advertiser has chosen not to accept applicants from your region.

    Production Engineer

    Mumbai, Maharashtra Snaphunt

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    The Offer

    • Attractive Salary & Benefits
    • Join a well known brand within Manufacturing
    • Work in a company with a solid track record of performance

    The Job

    You will be responsible for :

    • Managing the day to day production activities and ensuring that the production shopfloor and workstations are running smoothly and cost effectively.
    • Promoting operational excellence and production of high-quality products.
    • Liaising with different teams across the plant to ensure goals and objectives are met.
    • Driving continuous improvement regarding line efficiency by periodically reviewing performance results of production lines and taking corrective actions as necessary.
    • Ensuring health and safety guidelines are followed.
    • Reviewing worker performance and implementing coaching and training as required.
    • Managing a team of 50-100 people.

    The Profile

    • You have at least 5 years experience including solid experience in a similar role within Industrial.
    • You possess excellent communication and influencing skills, are organised and able to multi-task effectively.
    • You have working knowledge of diploma in mechanical engneer
    • You are highly goal driven and work well in fast paced environments
    • You possess strong analytical skills and are comfortable dealing with numerical data
    • You pay strong attention to detail and deliver work that is of a high standard
    • You are willing to undertake 30-60% travel.

    The Employer

    Our client was established in the year 1982 at MUMBAI, with Erection and commissioning of Hydraulic systems as prime objective. Company is under able control of Technocrats having decades of association with the Pioneers in Oil Hydraulic industry in INDIA today.

    This advertiser has chosen not to accept applicants from your region.

    Production Engineer

    Mumbai, Maharashtra Concord Hydraulics

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    CONCORD HYDRAULICS PVT. LTD. was established in the year 1982 at MUMBAI, with Erection and commissioning of Hydraulic systems as prime objective. Company is under able control of Technocrats having decades of association with the Pioneers in Oil Hydraulic industry in INDIA today. Company has grown since then and has progressed successfully in serving major core sector industries like Steel plants, Machine tools, Marine, Defence Organisation and many others. Company have modern facilities and group of highly skilled technical staff to cater for all the important and technically challenging requirements of today’s modern industry for design manufacturing of HYDRAULIC SYSTEMS, ERECTION and COMMISSIONING of High pressure and High flow hydraulic systems,hydraulic cylinders and accessories. Company also manufactures all types of tailor made Hydraulic and lubrication systems with components makes of your choice (Eaton-Vickers / Rexroth / Yuken / etc) . To cater for the all round requirement of industry under one roof, Company had diversified in small branches with various specialised services.

    The Role

    You will be responsible for :

    • Managing the day to day production activities and ensuring that the production shopfloor and workstations are running smoothly and cost effectively.
    • Promoting operational excellence and production of high-quality products.
    • Liaising with different teams across the plant to ensure goals and objectives are met.
    • Driving continuous improvement regarding line efficiency by periodically reviewing performance results of production lines and taking corrective actions as necessary.
    • Ensuring health and safety guidelines are followed.
    • Reviewing worker performance and implementing coaching and training as required.
    • Managing a team of 50-100 people.

    Ideal Profile

    • You have at least 5 years experience including solid experience in a similar role within Industrial.
    • You possess excellent communication and influencing skills, are organised and able to multi-task effectively.
    • You have working knowledge of diploma in mechanical engneer
    • You are highly goal driven and work well in fast paced environments
    • You possess strong analytical skills and are comfortable dealing with numerical data
    • You pay strong attention to detail and deliver work that is of a high standard
    • You are willing to undertake 30-60% travel.

    What's on Offer?

    • Attractive Salary & Benefits
    • Join a well known brand within Manufacturing
    • Work in a company with a solid track record of performance
    This advertiser has chosen not to accept applicants from your region.

    Production Engineer

    Mumbai, Maharashtra Concord Hydraulics

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    CONCORD HYDRAULICS PVT. LTD. was established in the year 1982 at MUMBAI, with Erection and commissioning of Hydraulic systems as prime objective. Company is under able control of Technocrats having decades of association with the Pioneers in Oil Hydraulic industry in INDIA today. Company has grown since then and has progressed successfully in serving major core sector industries like Steel plants, Machine tools, Marine, Defence Organisation and many others. Company have modern facilities and group of highly skilled technical staff to cater for all the important and technically challenging requirements of today’s modern industry for design manufacturing of HYDRAULIC SYSTEMS, ERECTION and COMMISSIONING of High pressure and High flow hydraulic systems,hydraulic cylinders and accessories. Company also manufactures all types of tailor made Hydraulic and lubrication systems with components makes of your choice (Eaton-Vickers / Rexroth / Yuken / etc) . To cater for the all round requirement of industry under one roof, Company had diversified in small branches with various specialised services.

    The Role

    You will be responsible for :

    • Managing the day to day production activities and ensuring that the production shopfloor and workstations are running smoothly and cost effectively.
    • Promoting operational excellence and production of high-quality products.
    • Liaising with different teams across the plant to ensure goals and objectives are met.
    • Driving continuous improvement regarding line efficiency by periodically reviewing performance results of production lines and taking corrective actions as necessary.
    • Ensuring health and safety guidelines are followed.
    • Reviewing worker performance and implementing coaching and training as required.
    • Managing a team of 50-100 people.

    Ideal Profile

    • You have at least 5 years experience including solid experience in a similar role within Industrial.
    • You possess excellent communication and influencing skills, are organised and able to multi-task effectively.
    • You have working knowledge of diploma in mechanical engneer
    • You are highly goal driven and work well in fast paced environments
    • You possess strong analytical skills and are comfortable dealing with numerical data
    • You pay strong attention to detail and deliver work that is of a high standard
    • You are willing to undertake 30-60% travel.

    What's on Offer?

    • Attractive Salary & Benefits
    • Join a well known brand within Manufacturing
    • Work in a company with a solid track record of performance
    This advertiser has chosen not to accept applicants from your region.

    Sr Lead Production Engineer

    Navi Mumbai, Maharashtra Quess Global Recruitment Services

    Posted 3 days ago

    Job Viewed

    Tap Again To Close

    Job Description

    Responsibilities

    Engineer 1. Production Performance Analysis and Optimization:

    a. Lead the analysis of oil and gas production performance using advanced modelling and research techniques.

    b. Utilize simulation software such as OLGA, PIPESIM, and PROSPER etc.to conduct in-depth studies and optimize field production.

    c. Conduct nodal analysis studies and apply production optimization techniques.

    d. Contribute to the development of long-term and Annual production plans, aligning with business objectives.

    2. Field Operations support:

    a. Advice operations with a focus on flow assurance, optimizing well performance.

    b. Identify and address deviations in operations and recommend corrective actions.

    c. Optimise field water production through Artificial lift systems and provide solutions to sustain and enhance gas production.

    d. Provide technical support in the planning and execution of new and innovative technologies.

    3. Technical Assurance and Compliance:

    a. Initiate technical proposals for improving reliability and productivity.

    b. Review and provide independent assurance on technical proposals from assets.

    c. Ensure compliance with industry standards and Codes, procedures, and company policies.

    d. Act as the second line of defense, offering technical validation and risk assessments.

    e. Ensure that all new processes and technologies are aligned with health, safety, and environmental regulations.

    4. Collaboration and Stakeholder Management:

    a. Work closely with asset and business teams.

    b. Collaborate with site teams for implementation of technical proposals.

    c. Mentor and lead a team of production engineers, fostering a culture of technical excellence.


    Please share your updated cv to

    This advertiser has chosen not to accept applicants from your region.

    Sr Lead Production Engineer

    Navi Mumbai, Maharashtra Quess Global Recruitment Services

    Posted 3 days ago

    Job Viewed

    Tap Again To Close

    Job Description

    Responsibilities
    Engineer 1. Production Performance Analysis and Optimization:
    a. Lead the analysis of oil and gas production performance using advanced modelling and research techniques.
    b. Utilize simulation software such as OLGA, PIPESIM, and PROSPER etc.to conduct in-depth studies and optimize field production.
    c. Conduct nodal analysis studies and apply production optimization techniques.
    d. Contribute to the development of long-term and Annual production plans, aligning with business objectives.
    2. Field Operations support:
    a. Advice operations with a focus on flow assurance, optimizing well performance.
    b. Identify and address deviations in operations and recommend corrective actions.
    c. Optimise field water production through Artificial lift systems and provide solutions to sustain and enhance gas production.
    d. Provide technical support in the planning and execution of new and innovative technologies.
    3. Technical Assurance and Compliance:
    a. Initiate technical proposals for improving reliability and productivity.
    b. Review and provide independent assurance on technical proposals from assets.
    c. Ensure compliance with industry standards and Codes, procedures, and company policies.
    d. Act as the second line of defense, offering technical validation and risk assessments.
    e. Ensure that all new processes and technologies are aligned with health, safety, and environmental regulations.
    4. Collaboration and Stakeholder Management:
    a. Work closely with asset and business teams.
    b. Collaborate with site teams for implementation of technical proposals.
    c. Mentor and lead a team of production engineers, fostering a culture of technical excellence.

    Please share your updated cv to
    This advertiser has chosen not to accept applicants from your region.
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    About the latest Manufacturing technology Jobs in Mumbai !

    Production Engineer (oil & Gas)

    Mumbai, Maharashtra Wings Global Services

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    Company Overview

    Wings Global Services stands at the forefront of engineering innovation, adeptly fusing automation with sector-specific insights to reshape industry paradigms. We pride ourselves on delivering cutting-edge solutions across various domains including oil & gas, manufacturing, and IT. Our dedication to operational excellence is matched by our commitment to developing industry-leading talent through advanced learning initiatives. Based in Mumbai, we thrive on driving efficiency and resource optimization for sustainable growth.


    Job Overview

    We are seeking a dynamic and experienced Production Engineer for the Oil & Gas sector at Wings Global Services. This full-time, mid-level position is based in our Mumbai headquarters. The ideal candidate should possess 4 to 6 years of relevant experience and bring a deep understanding of oilfield operations and advanced engineering solutions. You will play a pivotal role in driving efficiency and optimizing production processes in line with our strategic objectives.


    Qualifications and Skills

    • Extensive knowledge of production operations is essential for optimizing field productivity and enhancing operational efficiency.
    • Proven expertise in oilfield data analysis to interpret complex datasets and make informed decisions for process improvements.
    • Proficient in field development planning to strategize and implement development projects that align with company goals.
    • Comprehensive understanding of reservoir management to ensure optimal resource utilization and consistent yield over field lifespan.
    • Experience in hydraulic fracturing techniques to boost oil and gas extraction rates and extend production capabilities.
    • Solid grasp of petroleum engineering principles to innovate solutions and troubleshoot production challenges effectively.
    • Skilled in waterflood management to enhance oil recovery and manage reservoir pressure efficiently.
    • Capability to optimize well performance ensuring maximum output and operational sustainability with minimum downtime.


    Roles and Responsibilities

    • Coordinate and oversee daily production operations to ensure seamless execution and maximum efficiency.
    • Analyze and interpret data from production systems to identify areas for performance improvement and corrective actions.
    • Develop and implement field development plans focusing on enhancing production capabilities and resource management.
    • Collaborate with reservoir engineers to optimize recovery techniques and prolong asset lifespans.
    • Drive initiatives in hydraulic fracturing to improve extraction rates while ensuring safety and regulatory compliance.
    • Implement waterflood management strategies to maintain reservoir pressure and achieve optimum oil recovery.
    • Monitor and optimize well performance using state-of-the-art technologies and innovative methodologies.
    • Work closely with cross-functional teams to develop solutions aligned with company goals and client requirements.
    This advertiser has chosen not to accept applicants from your region.

    Sr Lead Production Engineer

    Navi Mumbai, Maharashtra Quess Global Recruitment Services

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    Responsibilities

    Engineer 1. Production Performance Analysis and Optimization:

    a. Lead the analysis of oil and gas production performance using advanced modelling and research techniques.

    b. Utilize simulation software such as OLGA, PIPESIM, and PROSPER etc.to conduct in-depth studies and optimize field production.

    c. Conduct nodal analysis studies and apply production optimization techniques.

    d. Contribute to the development of long-term and Annual production plans, aligning with business objectives.

    2. Field Operations support:

    a. Advice operations with a focus on flow assurance, optimizing well performance.

    b. Identify and address deviations in operations and recommend corrective actions.

    c. Optimise field water production through Artificial lift systems and provide solutions to sustain and enhance gas production.

    d. Provide technical support in the planning and execution of new and innovative technologies.

    3. Technical Assurance and Compliance:

    a. Initiate technical proposals for improving reliability and productivity.

    b. Review and provide independent assurance on technical proposals from assets.

    c. Ensure compliance with industry standards and Codes, procedures, and company policies.

    d. Act as the second line of defense, offering technical validation and risk assessments.

    e. Ensure that all new processes and technologies are aligned with health, safety, and environmental regulations.

    4. Collaboration and Stakeholder Management:

    a. Work closely with asset and business teams.

    b. Collaborate with site teams for implementation of technical proposals.

    c. Mentor and lead a team of production engineers, fostering a culture of technical excellence.


    Please share your updated cv to

    This advertiser has chosen not to accept applicants from your region.

    Production Engineer (oil & Gas)

    Mumbai, Maharashtra Wings Global Services

    Posted 13 days ago

    Job Viewed

    Tap Again To Close

    Job Description

    full-time

    Company Overview

    Wings Global Services stands at the forefront of engineering innovation, adeptly fusing automation with sector-specific insights to reshape industry paradigms. We pride ourselves on delivering cutting-edge solutions across various domains including oil & gas, manufacturing, and IT. Our dedication to operational excellence is matched by our commitment to developing industry-leading talent through advanced learning initiatives. Based in Mumbai, we thrive on driving efficiency and resource optimization for sustainable growth.


    Job Overview

    We are seeking a dynamic and experienced Production Engineer for the Oil & Gas sector at Wings Global Services. This full-time, mid-level position is based in our Mumbai headquarters. The ideal candidate should possess 4 to 6 years of relevant experience and bring a deep understanding of oilfield operations and advanced engineering solutions. You will play a pivotal role in driving efficiency and optimizing production processes in line with our strategic objectives.


    Qualifications and Skills

    • Extensive knowledge of production operations is essential for optimizing field productivity and enhancing operational efficiency.
    • Proven expertise in oilfield data analysis to interpret complex datasets and make informed decisions for process improvements.
    • Proficient in field development planning to strategize and implement development projects that align with company goals.
    • Comprehensive understanding of reservoir management to ensure optimal resource utilization and consistent yield over field lifespan.
    • Experience in hydraulic fracturing techniques to boost oil and gas extraction rates and extend production capabilities.
    • Solid grasp of petroleum engineering principles to innovate solutions and troubleshoot production challenges effectively.
    • Skilled in waterflood management to enhance oil recovery and manage reservoir pressure efficiently.
    • Capability to optimize well performance ensuring maximum output and operational sustainability with minimum downtime.


    Roles and Responsibilities

    • Coordinate and oversee daily production operations to ensure seamless execution and maximum efficiency.
    • Analyze and interpret data from production systems to identify areas for performance improvement and corrective actions.
    • Develop and implement field development plans focusing on enhancing production capabilities and resource management.
    • Collaborate with reservoir engineers to optimize recovery techniques and prolong asset lifespans.
    • Drive initiatives in hydraulic fracturing to improve extraction rates while ensuring safety and regulatory compliance.
    • Implement waterflood management strategies to maintain reservoir pressure and achieve optimum oil recovery.
    • Monitor and optimize well performance using state-of-the-art technologies and innovative methodologies.
    • Work closely with cross-functional teams to develop solutions aligned with company goals and client requirements.
    This advertiser has chosen not to accept applicants from your region.
     

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