CNC Jobs
5 Jobs Found
<h2 class="h5">Job description</h2>
<div class="t-break" data-jb-field="description">
<br>Company Description<br><br><p><strong>About AbbVie</strong></p><br><p>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.</p><br><br>Job Description<br><br><p>The Director I Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers and management in RA, R&D, and Operations. Serves as strategic liaison with regulatory agencies (e.g., FDA) regarding CMC matters. May include formal supervisory responsibilities. Manages assigned projects within assigned resources.</p><br><p>Responsibilities</p><br><p>List up to 10 main responsibilities for the job. Include information about the accountability and scope.</p><br><ul><li>Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new IND/CTA applications and amendments, new marketing authorization submissions, renewals, annual reports, supplements and variations, and/or leads a global RA CMC team who develops strategies for development and marketed products</li><li>Advises internal personnel on regulatory strategies. Provides strategic regulatory advice to peers and management in RA, R&D, and Operations. Seeks internal and external expert advice and technical support when necessary.</li><li>Reviews and revises regulatory submission documentation to effectively present data and strategy to regulatory agencies. Devises regulatory strategies for complicated scenarios (e.g., complex dosage form or multiple operational changes, aggressive timelines).</li><li>Develops strategies for CMC-related agency interactions and manages preparation of agency meeting requests and information packages. Serves as the point of contact for the regulatory agency meetings and leads CMC discussion for projects with health authorities. Drives strategic change planning with Manufacturing Operations using a risk-based approach centered on assessment of potential impact to quality, safety or efficacy.</li><li>Manages products and change control in compliance with an understanding of regulations, guidances and company policies and procedures. Analyzes and approves manufacturing change records.</li><li>Represents RA CMC on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of regulatory submissions</li><li>Stays abreast of regulatory procedures and changes in external regulatory environment. Analyzes legislation, regulation and guidance and provides analysis to the organization. Leads creation of white papers and policies to illustrate current regulatory thinking.</li><li>Designs initiatives to drive business efficiencies across the organization (within or outside of the regulatory groups). Ensures enterprise culture initiatives are implemented across RA CMC.</li><li>Trains, develops and mentors individuals; may include formal supervisory responsibilities of product leads. Evaluates performance of and assists in career development planning for assigned staff.</li></ul><br>Qualifications<br><br><ul><li>Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject</li><li>Preferred Education: Relevant advanced degree preferred. Certification a plus</li><li>Required Experience: 10 years biopharmaceutical experience with 3-plus years demonstrated enterprise leadership. 5-plus years in RA or relevant exposure to RA activities</li><li>Preferred Experience: 10-plus years biopharmaceutical RA, R&D, or Operations experience, including 7-plus years in regulatory affairs</li><li>Experience developing and implementing successful global regulatory strategies</li><li>Interfacing ability with government regulatory agencies</li><li>Success leading in a complex and matrix environment.</li><li>Strong understanding of the business/enterprise</li><li>Strong oral and written communication skills.</li></ul><br>Additional Information<br><br><p>Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: </p><br><ul><li><p>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. </p><br></li><li><p>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.</p><br></li><li><p>This job is eligible to participate in our long-term incentive programs. </p><br></li></ul><p>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.</p><br><p>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. </p><br><p>US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</p><br><p>US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:</p><br><p>https://www.abbvie.com/join-us/reasonable-accommodations.html</p><br> </div>
<h2 class="h5">Job description</h2>
<div class="t-break" data-jb-field="description">
<br>Company Description<br><br><p><strong>About AbbVie</strong></p><br><p>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.</p><br><br>Job Description<br><br><p>Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule products Plays a key leadership role within S&T PPG group.</p><br><p>Responsibilities</p><br><ul><li>Lead cross-functional S&T product teams and represent the CMC team and/or S&T in interface with S&T leadership, other Operations functions, other AbbVie functions and external partners. Participate in or coordinate Governance efforts such as Product Performance Teams or gate reviews.</li><li>Develop and maintain comprehensive project plans, budgets, timelines and strategy; technical projects at all stages of development are included, from phase II through commercial.</li><li>Ensure sound, proactive technical ownership of the product, process and methods by the CMC team; facilitate the identification and resolution of technical issues and prioritization of efforts with strategic understanding of impact on Operations.</li><li>Understand and present technical information regarding drug product and drug substance manufacturing processes and methods, process development/history and process characterization to management and regulatory agencies.</li><li>Review submissions through registration of the product as well as post-approval life-cycle management. Serve as a peer/management reviewer for submissions.</li><li>Represent assigned projects on the multidisciplinary Product Presentation and Device Strategy Team and collaborate with multidisciplinary team including R&D, RA, and Operations (MES, QA, sites, Supply Chain, purchasing, etc.)</li><li>Manage multiple and/or complex projects at various stages of development, commercialization and commercial manufacturing.</li><li>Develop new and less experienced CMC leads through sponsor/mentor relationships.</li><li>Identify and promote best practices among S&T CMC leads.</li><li>Establish and foster partnerships with key customers and counterpart functions to facilitate effective collaboration.</li></ul><br>Qualifications<br><br><ul><li>Bachelor ’s Degree with 16+ years of relevant experience (CMC, small molecule manufacturing/development); Master’s Degree with 14+ years of relevant experience; PhD Degree with at least 12+ years of relevant experience.</li><li>CMC development experience through IND and/or NDA/MAA.<br>Experience leading multiple CMC project teams through IND and NDA/MAA preferred.</li><li>Technical understanding and experience with small molecule products manufacturing, development, quality and analytics is required.</li><li>Knowledge and experience with FDA and global regulatory requirements for CMC issues is required.<br>Ability to influence internal and external experts on CMC regulatory issues, independently.</li><li>Demonstrated excellence in writing, presentation, and overall communication.</li><li>Demonstrated excellence in leading CMC project teams.</li><li>Demonstrated ability to provide strategic direction for work groups, departments, etc.</li></ul><br>Additional Information<br><br><p>Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: </p><br><ul><li><p>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. </p><br></li><li><p>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.</p><br></li><li><p>This job is eligible to participate in our long-term incentive programs. </p><br></li></ul><p>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.</p><br><p>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. </p><br><p>US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</p><br><p>US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:</p><br><p>https://www.abbvie.com/join-us/reasonable-accommodations.html</p><br> </div>
<h2 class="h5">Job description</h2>
<div class="t-break" data-jb-field="description">
<br>Company Description<br><br><p><strong>About AbbVie</strong></p><br><p>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.</p><br><br>Job Description<br><br><p>Abbvie Product Development Science and Technology (PDS&T) Biologics Analytical-CMC Strategy is responsible for driving the analytical CMC control strategy for late-stage development of biologics. The Analytical CMC Strategy team is responsible for ensuring late phase to commercial method development, optimization, validation, advanced characterization, process development support, regulatory authoring, and control strategy for biologics. The team works cross-functionally with process development, regulatory, and quality within the Abbvie network. This role requires a strategic thinker with a strong technical analytical background in gene therapy and tLNP technologies, manage complex projects, and effectively communicate cross-functionally. </p><br><p><u><strong>Responsibilities:</strong></u></p><br><ul><li>Drives overall analytical control strategy, including justifying appropriate specifications, determining critical quality attributes, assessing product shelf-life, and risk-based comparability strategies for the biologics pipeline.</li><li>Establish collaborations across the organization to ensure delivery of critical analytical BLA enabling activities.</li><li>Setting team strategies, managing resources and defining risk mitigation strategies.</li><li>Communicate project strategy, key issues, and risks to relevant teams and escalate risks and facilitate resolution within/across functional areas.</li><li>Act as the principal contact for all stakeholders and balance conflicting expectations between cross-functional areas.</li><li>Actively participate in yearly FTE planning across the analytical organization</li></ul><br>Qualifications<br><br><ul><li>Bachelor’s Degree or equivalent education in Science related field with extensive (typically 18 years) of related work; Master’s Degree or equivalent education Science or PharmD or equivalent education with extensive (typically 16 years) of related work; PhD in Science or related field with typically 10 years of related work experience.</li><li>Experience in research and/or development environment.</li><li>Proven ability to innovate with a history of new or improved product releases.</li><li>Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators.</li><li>Demonstrated ability to influence others across areas of scientific disciplines.</li><li>Technical background in healthcare, laboratory diagnostics, medical devices or pharmaceutical companies.</li></ul><br>Additional Information<br><br><p>Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: </p><br><ul><li><p>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. </p><br></li><li><p>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.</p><br></li><li><p>This job is eligible to participate in our long-term incentive programs. </p><br></li></ul><p>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.</p><br><p>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. </p><br><p>US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</p><br><p>US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:</p><br><p>https://www.abbvie.com/join-us/reasonable-accommodations.html</p><br> </div>
<h2 class="h5">Job description</h2>
<div class="t-break" data-jb-field="description">
<br>Company Description<br><br><p><strong>About AbbVie</strong></p><br><p>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.</p><br><br>Job Description<br><br><p>The <strong>Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) - Biologics Product Lead</strong>, works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision. Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations.</p><br><p><u><strong>Responsibilities:</strong></u></p><br><ul><li>Prepares CMC regulatory product strategies with limited supervision. Prepares regulatory submissions, including new IND/CTA applications and amendments, renewals, annual reports, supplements and variations under limited supervision.</li><li>Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions</li><li>Reviews and revises regulatory submission documentation to effectively present data and strategy to regulatory agencies under limited supervision</li><li>Responds to global regulatory information requests under limited supervision.</li><li>Develops strategies for CMC-related agency interactions and manages preparation of agency meeting requests and information packages, under limited supervision</li><li>Manages products and change control with an understanding of regulations, agency guidance and company policies and procedures with limited supervision. Analyzes and approves manufacturing change records with limited supervision.</li><li>Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions and stays abreast of regulatory procedures and changes in the external regulatory environment.</li><li>Analyzes legislation, regulation and guidance and provides analysis to the organization under limited supervision</li><li>Contributes to creation of white papers and policies to illustrate current regulatory thinking under supervision of manager. Participates in initiatives internal to RA CMC</li><li>May act as a formal or informal mentor to others.</li><li>This position will work a hybrid work schedule (3 days in office) from the AbbVie Lake County, IL; Irvine, CA or Waltham, MA headquarters. </li></ul><p>Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required</p><br><br>Qualifications<br><br><ul><li>Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.</li><li>Preferred Education: Relevant advanced degree preferred. Certification a plus.</li><li>Required Experience: 6 years biopharmaceutical or related industry experience.</li><li>Preferred Experience: 6 years biopharmaceutical RA, R&D or Operations experience including 3 years in regulatory affairs</li><li>Experience working in a complex and matrix environment</li><li>Strong oral and written communication skills</li></ul><br>Additional Information<br><br><p>Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: </p><br><ul><li><p>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. </p><br></li><li><p>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.</p><br></li><li><p>This job is eligible to participate in our long-term incentive programs. </p><br></li></ul><p>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.</p><br><p>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. </p><br><p>US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</p><br><p>US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:</p><br><p>https://www.abbvie.com/join-us/reasonable-accommodations.html</p><br> </div>
<h2 class="h5">Job description</h2>
<div class="t-break" data-jb-field="description">
<br>Company Description<br><br><p><strong>About AbbVie</strong></p><br><p>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.</p><br><br>Job Description<br><br><p>The <strong>Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)</strong> works with internal and external partners to deliver products to patients to deliver biologics products to patients, including mAb, ADC and cell & gene therapies. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice.</p><br><p><u><strong>Responsibilities:</strong></u></p><br><ul><li>Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations and responds to regulatory information</li><li>Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions</li><li>Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies</li><li>Responds to global regulatory information requests.</li><li>Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions.</li><li>Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.</li><li>Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions</li><li>Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization</li><li>Develops, implements, and documents policies and procedures within the regulatory affairs department. Participates in initiatives internal to RA CMC.<br>Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.</li><li>This role will work a hybrid work schedule (3 days in office & 2 days remote) from the Waltham, MA & Lake County, IL headquarters. </li></ul><p>Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required</p><br><br>Qualifications<br><br><ul><li>Required Education: Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject. Preferred Education: Relevant advanced degree preferred. Certification a plus.</li><li>Required Experience: 8 years pharmaceutical experience. Preferred Experience: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing.</li><li>Experience developing and implementing successful global regulatory strategies.</li><li>Experience working in a complex and matrix environment.</li><li>Strong oral and written communication skills.</li><li>Note: Higher education may compensate for years of experience</li></ul><br>Additional Information<br><br><p>Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: </p><br><ul><li><p>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. </p><br></li><li><p>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.</p><br></li><li><p>This job is eligible to participate in our long-term incentive programs. </p><br></li></ul><p>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.</p><br><p>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. </p><br><p>US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</p><br><p>US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:</p><br><p>https://www.abbvie.com/join-us/reasonable-accommodations.html</p><br> </div>