BioSpace
Director, External Manufacturing Aseptic ( On-site based in IL, NJ or MA)
BioSpace, North Chicago, Illinois, us, 60086
Director, External Manufacturing Aseptic ( On-site based in IL, NJ or MA)
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Director, External Manufacturing Aseptic ( On-site based in IL, NJ or MA)
role at
BioSpace .
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
Job Description Manage a team of Manufacturing Professionals assigned to Third Party Manufacture (TPM) contracts for Aseptic Manufacturing and DS Conjugation (ADCs) products. Assure that high quality product is manufactured in compliance with local and international regulations, and released and delivered according to the established forecasts, schedules, and cost planned.
Responsibilities
Lead a team of AbbVie TPM Account Managers to negotiate Manufacturing Service Agreement and amendments, ensure compliance with agreements and effective planning and material procurement strategies.
Assure global logistics support all phases of the manufacturing agreement according to Purchasing and Supplier quality expectations.
Ensure timely communication to TPM in all aspects of the product agreement including product forecasts, manufacturing and delivery schedules.
Lead the development of Financial Operating Plan, Updates, LRP, and Standard processes, and assure financial goals are met.
Monitor manufacturing performance; apply performance metrics as appropriate and ensure work processes and standards align to deliver product according to AbbVie quality expectations.
Assure in coordination with internal AbbVie functional partners that TPM has required quality systems and documentation to meet regulatory requirements, follow up inspection responses and commitments; coordinate with QA, annual quality management review and periodic audits of TPM; assure deviations properly investigated and product disposition decisions timely.
Lead a performance improvement culture & programs across TPMs; guide Account Managers to anticipate and act on ideas to increase efficiency and effectiveness.
Partner with AbbVie stakeholder groups to facilitate resolution of technical, quality, or supply issues.
Coach managers in the organization and establish clear expectations with them and all employees regarding responsibilities, goals and behaviours and champion and model exceptional AbbVie performance and talent management practices.
Coordinate routine management reviews and provide ongoing communication informing internal and TPM stakeholders of TPM performance against expectations, highlighting issues, actions, and on-going improvements to increase performance at TPMs.
Represent Manufacturing as required with internal Brand Teams related to all aspects of the manufacturing process with TPMs and develop and manage staff through hiring, managing performance, developing talent and providing clear expectations.
Qualifications
Bachelors Degree required in a technical field; advanced technical degree (Masters or Doctorate Degree) strongly preferred.
15+ years experience including individual contributor building technical expertise and proven project management skills.
Progressively increased responsibility and performance as supervisor, department manager and leader of diverse teams in Operations (Manufacturing, Quality, Supply Chain, Engineering, etc.).
Business acumen coupled with functional leadership experience required to ensure effectiveness and high performance in a complex operation.
Additional Information
Salary: $156,000 - $296,500.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs.
Equal Opportunity Employer AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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Director, External Manufacturing Aseptic ( On-site based in IL, NJ or MA)
role at
BioSpace .
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
Job Description Manage a team of Manufacturing Professionals assigned to Third Party Manufacture (TPM) contracts for Aseptic Manufacturing and DS Conjugation (ADCs) products. Assure that high quality product is manufactured in compliance with local and international regulations, and released and delivered according to the established forecasts, schedules, and cost planned.
Responsibilities
Lead a team of AbbVie TPM Account Managers to negotiate Manufacturing Service Agreement and amendments, ensure compliance with agreements and effective planning and material procurement strategies.
Assure global logistics support all phases of the manufacturing agreement according to Purchasing and Supplier quality expectations.
Ensure timely communication to TPM in all aspects of the product agreement including product forecasts, manufacturing and delivery schedules.
Lead the development of Financial Operating Plan, Updates, LRP, and Standard processes, and assure financial goals are met.
Monitor manufacturing performance; apply performance metrics as appropriate and ensure work processes and standards align to deliver product according to AbbVie quality expectations.
Assure in coordination with internal AbbVie functional partners that TPM has required quality systems and documentation to meet regulatory requirements, follow up inspection responses and commitments; coordinate with QA, annual quality management review and periodic audits of TPM; assure deviations properly investigated and product disposition decisions timely.
Lead a performance improvement culture & programs across TPMs; guide Account Managers to anticipate and act on ideas to increase efficiency and effectiveness.
Partner with AbbVie stakeholder groups to facilitate resolution of technical, quality, or supply issues.
Coach managers in the organization and establish clear expectations with them and all employees regarding responsibilities, goals and behaviours and champion and model exceptional AbbVie performance and talent management practices.
Coordinate routine management reviews and provide ongoing communication informing internal and TPM stakeholders of TPM performance against expectations, highlighting issues, actions, and on-going improvements to increase performance at TPMs.
Represent Manufacturing as required with internal Brand Teams related to all aspects of the manufacturing process with TPMs and develop and manage staff through hiring, managing performance, developing talent and providing clear expectations.
Qualifications
Bachelors Degree required in a technical field; advanced technical degree (Masters or Doctorate Degree) strongly preferred.
15+ years experience including individual contributor building technical expertise and proven project management skills.
Progressively increased responsibility and performance as supervisor, department manager and leader of diverse teams in Operations (Manufacturing, Quality, Supply Chain, Engineering, etc.).
Business acumen coupled with functional leadership experience required to ensure effectiveness and high performance in a complex operation.
Additional Information
Salary: $156,000 - $296,500.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs.
Equal Opportunity Employer AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
#J-18808-Ljbffr