Director, External Manufacturing

BioSpace; North Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Comprehensive benefits package

Paid time off

401(k) plan

Job summary

A global biopharmaceutical company based in North Chicago is seeking a Director, External Manufacturing. This role involves managing a team responsible for Third Party Manufacture contracts, ensuring high-quality products meet local and international regulations. The ideal candidate will have over 15 years of experience in manufacturing medical devices and possess strong leadership and communication skills. The position offers a comprehensive benefits package and opportunities in short and long-term incentive programs.

Qualifications

• 15+ years of experience in manufacturing of Medical or Electro-Mechanical Devices.
• Proven ability to inclusively manage and develop teams.
• Progressively increased responsibility in Operations roles.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Manage a team of Manufacturing Professionals responsible for TPM contracts.
• Lead negotiations and management of Manufacturing Service Agreements.
• Monitor manufacturing performance and apply OPEX metrics.
• Monitor performance using OPEX metrics and drive continuous improvement across TPMs.
• Identify and manage third-party manufacturers and oversee onboarding, negotiations, and renewals.

Skills

Strong communication skills

Technical and manufacturing assembly management

Business acumen

Business acumen

Regulatory/compliance awareness

Education

Bachelor's Degree in a technical field

Master's or Doctorate Degree

Job description

Overview

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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. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose

Manage a team of Manufacturing Professionals responsible for Third Party Manufacture (TPM) contracts for Medical Devices or Combination Products. Assure that high quality products are manufactured in compliance with local and international regulations, and released and delivered according to the established forecasts, schedules, and cost planned. On going monitoring quality and delivery performance while minimizing risks associated with outsourcing production to a Third-Party Manufacturer.

Responsibilities

• Lead a team of AbbVie TPM Account Managers to: Negotiate and manage Manufacturing Service Agreements (MSA), contract Amendments, and updates as needed, while ensuring compliance with the terms of the agreements. Asure global logistics are in place to support all phases of the manufacturing agreement in accordance with Purchasing and Supplier Quality expectations.


• Lead the development of ECM Device Financial Operating Plan, Updates, LRP, and Standard processes, and assure the financial goals are met. Monitor and control manufacturing costs to ensure efficient use of resources while maintaining product quality.


• Ensure timely communication with TPM in all aspects of the product agreement including product forecasts, manufacturing and delivery schedules. Identify, evaluate, and maintain strong relationships with third-party manufacturers to ensure quality production and timely delivery.


• Monitor manufacturing performance; apply OPEX (Operational Excellence) metrics as appropriate and ensure TPM manufacturing processes and standards align to deliver product in accordance with AbbVie quality & performance expectations.


• Assure in coordination with internal AbbVie functional partners that the TPM has the required quality systems and documentation to meet regulatory requirements, follow up inspection responses and commitments. Coordinate with PQA, the annual quality management review and periodic audits of the TPM. Assure deviations are properly investigated and product disposition decisions are made in a timely manner.


• Coordinate routine management reviews and provide on-going communication informing internal and TPM stakeholders of performance against expectations, highlighting issues, actions, and on-going improvements to increase performance at TPMs.


• Identifying and Selection of Third-Party Manufacturers (TPM); ensure team engagement on cross functional evaluation of new product needs and TPMs due diligence initiatives.


• Identify, evaluate, and maintain strong relationships with third-party manufacturers to ensure quality production and timely delivery from onboarding, contract negotiations though renewals of the TPM.


• Identify potential disruptions like geopolitical instability, natural disasters, or labor issues and develop mitigation strategies.


• Ensure the manufacturer adheres to all relevant regulations regarding safety, environmental standards, and labor practices.


• Foster a collaborative partnership with TPMs to ensure mutual understanding and commitment to quality & performance.


• Lead a performance improvement culture & programs across TPMs; guide Account Managers to anticipate and act on ideas to increase efficiency and effectiveness.


• Establish and manage clear team expectations regarding roles & responsibilities, GOs while champion and model AbbVie's performance and talent management practices.


• 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: manufacturing of Medical or Electro-Mechanical Devices


• Strong technical and manufacturing assembly management experience


• Progressively increased responsibility and performance as supervisor, department manager and leader in Operations (Manufacturing, Quality, Engineering, etc..) Proven ability to inclusively manage and develop teams.


• Strong communication skills, ability to build trust and rapport, clear goal setting, fostering collaboration, promoting creativity, and adapting leadership style to suit the team's needs.


• Business acumen coupled with functional leadership experience is required to ensure effectiveness and high performance in a complex operation.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.


• 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.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

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.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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