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Cmc In Biotech information

How is CMC used in pharmaceuticals?

In the context of CMC (Chemistry, Manufacturing, and Controls) in biotech jobs, CMC involves developing and controlling the processes for producing pharmaceuticals, ensuring product quality, safety, and efficacy. It includes activities like formulation development, process validation, and stability testing, often requiring knowledge of regulatory requirements and laboratory skills.

What is the difference between Cmc In Biotech vs Formulation Scientist?

AspectCmc In BiotechFormulation Scientist
Required CredentialsBachelor's or Master's in Life Sciences, Good Manufacturing Practice (GMP) knowledgeBachelor's or Master's in Pharmacy, Chemistry, or related field; GMP experience
Work EnvironmentLaboratories, manufacturing facilities, regulatory settingsLaboratories, R&D departments, manufacturing units
Employer & Industry UsageBiotech companies, pharmaceutical firms, contract manufacturing organizationsPharmaceutical companies, biotech firms, contract labs

While both roles operate within the biotech and pharmaceutical industries, Cmc In Biotech focuses on Chemistry, Manufacturing, and Controls documentation and regulatory compliance, whereas Formulation Scientists primarily develop and optimize drug formulations. Cmc In Biotech professionals ensure regulatory submissions are complete, while Formulation Scientists work on creating effective drug delivery systems. Both roles often collaborate but serve distinct functions within the product development pipeline.

What is a CMC in biotech?

In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes involved in developing and producing a pharmaceutical product. CMC professionals ensure that drugs are manufactured consistently, meet quality standards, and comply with regulatory requirements, often working with laboratory techniques, quality assurance, and regulatory submissions.

What is the highest paying job in biotech?

In biotech, senior executive roles such as Chief Scientific Officer (CSO) or Vice President of Research typically have the highest salaries, often exceeding $200,000 annually. These positions require extensive experience, advanced degrees, and leadership skills in research and development environments.

What are CMC jobs?

CMC jobs in biotech refer to roles involved in Chemistry, Manufacturing, and Controls activities, which ensure the quality, safety, and efficacy of biopharmaceutical products. These positions often require knowledge of regulatory requirements, laboratory skills, and experience with process development and validation. CMC professionals play a critical role in drug development and manufacturing compliance.
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Associate Director, CMC Portfolio Management

Associate Director, CMC Portfolio Management

AbbVie

North Chicago, IL • On-site

$141K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 9 days ago

AbbVie rating

8.7

Company rating: 8.7 out of 10

Based on 100 frontline employees who took The Breakroom Quiz

12th of 74 rated pharmaceutical

Job description

Company Description
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Associate Director, CMC Portfolio Management leads with the development and maintenance of Chemistry, Manufacturing, and Controls (CMC) project plans for Product Presentation & Device Strategy Teams (PPDST) using standardized project management tools and processes. These CMC plans are used for decision making on drug development teams and across the R&D portfolio. Responsibilities include maintaining accurate PPDST rosters, generation of timeline swim lanes, and scenario planning interacting with Program Development Directors and key external stakeholders within R&D/Ops/Commercial. Additional responsibilities include Early Biologics Excellence (EBE) pre-clinical timeline support. The candidate is expected to quickly excel at program management responsibilities and seek to establish themselves as a strategic leader of their teams and strong representative of the Development Sciences organization to senior leaders and cross-functional partners.
Responsibilities:
  • Independently provide advanced and extensive project management support to multiple complex (e.g. early-mid stage, requiring a device, etc.) drug development projects, including creation and maintenance of CMC technical plans in Asset Management Platform (AMP), PPDST roster management, and timeline swim lanes for relevant program reviews.
  • Leads the PPDST Team meetings, including setting agenda topics, capturing action items, and driving discussions with PPDST members. Drives PPDST team accountability to meet project deliverables. Develops multiple project planning scenarios in collaboration with PPDST team members; identifies, monitors, and analyzes business risks. Recognizes when corrective action and planning are necessary and conducts root cause analyses (escalating recommendations to PPDST Team).
  • Manage activities to ensure functions have the right tools, reports, and AMP data for accurate resource estimates. Supports organization/communication of knowledge management materials (e.g. SharePoint/Team sites, etc.) for PPDST teams.
  • Independently identifies opportunities for improvement of departmental work processes and manages large and small cross-functional process improvement initiatives. Contributes to defining departmental vision and strategy. Converts departmental and cross-functional goals to tasks and coordinates activities to meet goals. Estimates and manages requirements to achieve defined objectives.
  • Lead multiple process improvement teams through execution on defined objectives and keep management informed of progress and achieved project milestones. Apply advanced and extensive project management principles and techniques to the coordination and completion of assigned goals and tasks. Prioritize tasks with effective use of time.
  • Support and advise peer Project Managers/PPDST Co-Chairs on monthly project plan issues and timelines for maintenance and information reporting. Provide data entry for change requests.
  • Apply advanced project management tools for metrics collection and conduct advanced analysis of project data. Develop guidelines and checklists. Utilize and implement tools to identify novel solutions for metrics collection, data analysis and process improvement.
  • Serves as local expert for business procedures and recommends solutions to R&D (Development Sciences, Regulatory, etc). Develop and provide advanced training courses, presentations, and guidance to foster best practices. Mentor junior staff on training, presentation development, and delivery.
  • Establish and maintain strong network within department and external stakeholders. Utilize established organizational network to identify opportunities, gaps and synergies consistent with departmental strategy. Actively manages cross-functional and departmental team behaviors, mediates internal team disputes, and facilitates establishment of high performing teams. May manage Sr. Specialists and/or Program Managers within the department.
  • Interacts with all levels of employees in support of project coordination. Effectively influences senior R&D leaders regarding project initiatives and direction. Defines performance expectations and assesses progress against plans, processes, and practices to determine effectiveness and areas for process improvement.

Qualifications
  • Bachelors degree required in a technical or scientific related discipline and 10+ years professional work experience in the pharmaceutical or biotech industry; or Masters degree with 8+ years of work experience; or Doctorate degree with 4+ years of work experience in same disciplines.
  • Note: Higher education may compensate for years of experience; years of experience may compensate for education
  • Accreditation in a project management or process improvement discipline highly preferred (e.g. Project Management Professional, LEAN Six Sigma, etc.).
  • 4+ years Project Management experience, including leadership of a cross-functional team required. Must be able to demonstrate knowledge of project management principles. Ability to work independently and represent sound strategies is required.
  • Must have clear leadership skills that minimally include: strong written and effective interpersonal communication; capability to clearly present, influence, and logically justify proposals; sound judgment; negotiation and conflict management; effective communication across cultures and disciplines; relationship building and fostering teamwork; and training experience.
  • Job requires knowledge of the drug development process.
  • Cross-functional and global project team leadership experience required.
  • Expertise in the tools and techniques of Project Management and/or Business Excellence (e.g., MS Office software, MS Project, Qlikview, Spotfire, etc.) required.
  • CMC experience required.

Key Stakeholders:
Development project program directors/PPDST Co-Chairs, Asset PMTs, PPDST/AST development team representatives, Dev. Sci. Business Operations, Dev. Sci Finance, and CMC Portfolio Management group.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
  • 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 thisposting 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 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 anduntil 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, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html

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About AbbVie

Sourced by ZipRecruiter

AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.

Industry

Scientific research and development services

Company size

10,000+ Employees

Headquarters location

North Chicago, IL, US

Year founded

2013

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