Associate Director, CMC-Pharma Product Group

AbbVie Inc.Waltham

On-site Full-time

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Experience Level

Mid to Senior

Qualifications

The ideal candidate will possess a Master's degree in a relevant field with a minimum of 5 years of experience in pharmaceutical development and manufacturing. Strong leadership skills, excellent communication abilities, and a solid understanding of CMC regulatory requirements are essential. Proven experience in project management and a track record of successful product launches will set you apart.

About the job

Join AbbVie as an Associate Director in our CMC-Pharma Product Group, where you will play a pivotal role in leading cross-functional teams to drive the development and manufacturing of high-quality pharmaceutical products. Your expertise will be crucial in ensuring compliance with regulatory standards and enhancing our product portfolio.

About AbbVie Inc.

AbbVie Inc. is a global, research-driven biopharmaceutical company committed to developing innovative solutions to address the world's most complex health challenges. Our mission is to discover and develop advanced therapies that improve patient outcomes and enhance quality of life.

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Associate Director of Clinical Operations

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Full-time|$182K/yr - $208K/yr|Hybrid|Waltham, Massachusetts, United States

Oruka Therapeutics is developing biologics designed to change the treatment landscape for chronic skin conditions such as plaque psoriasis. The company focuses on long-lasting relief for patients, aiming for outcomes like disease clearance with infrequent dosing. Their pipeline includes proprietary antibodies created by Paragon Therapeutics, targeting the underlying causes of dermatologic and inflammatory diseases. More details about their work can be found at www.orukatx.com. Role overview The Associate Director of Clinical Operations will manage the setup and execution of clinical trials, supporting the Director of Clinical Operations within a specific therapeutic area. This position oversees multiple studies, combining strategic planning with day-to-day operational involvement to keep clinical programs on track and within budget. Responsibilities include handling operational details, anticipating challenges, and implementing solutions to ensure trial progress. The role requires someone who can move between leadership and hands-on work, maintaining a player/coach mindset throughout. What you will do Oversee all phases of clinical trial setup and execution across several studies Support the Director of Clinical Operations in a designated therapeutic area Balance strategic planning with direct, hands-on involvement in daily operations Identify and resolve operational challenges to maintain study timelines and budgets Requirements Demonstrated integrity and sound judgment in clinical operations Ability to shift between high-level oversight and direct involvement as needed Strong commitment to study goals and a collaborative approach Adaptability and resourcefulness in a biotech setting This hybrid role is based in Waltham, Massachusetts, with an expectation of three days onsite each week. The team values learning, growth, and a positive, inclusive culture.

Apr 22, 2026

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Associate Director/Director of Analytical & GMP Quality Assurance Operations

Crescent Biopharma

Full-time|On-site|Waltham, MA

At Crescent Biopharma, we aspire to transform the landscape of oncology by developing cutting-edge therapies tailored for cancer patients. Our innovative pipeline includes a leading PD-1 x VEGF bispecific antibody, alongside state-of-the-art antibody-drug conjugates. By harnessing diverse therapeutic modalities and established targets, we aim to expedite the development of potentially groundbreaking treatments, whether as standalone interventions or in combination therapies targeting various solid tumors. For more insights into our mission and vision, visit our website and connect with us on LinkedIn and X.We are currently in search of an Associate Director or Director of Analytical & GMP Quality Assurance Operations. In this pivotal role, you will oversee and guide the QA functions related to analytical development, quality control operations, and GMP quality activities across our clinical-stage biologics and ADC programs. Collaboration with cross-functional teams, including CMC, Analytical Sciences, Quality Control, and Technical Operations, as well as external manufacturing and testing partners, will be key to ensuring compliance with phase-appropriate GMP standards, maintaining data integrity, and ensuring inspection readiness within a dynamic outsourced operational framework. Your strategic vision will be instrumental in shaping Crescent's analytical quality strategy and driving the disciplined execution of core quality systems that align with our aggressive development timelines.

Mar 10, 2026

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Director of Clinical Operations

Deciphera Pharmaceuticals, Inc.

Full-time|On-site|Waltham

Role Overview:The Director of Clinical Operations plays a pivotal role in ensuring that clinical stage programs meet both strategic and operational objectives in compliance with set timelines, budgets, and quality standards. This leadership position is vital in guiding the Clinical Operations team, shaping clinical program strategies, and fostering collaboration and transparency across multiple functions. The Director will work closely with both internal stakeholders and external partners to facilitate high-quality clinical trial execution within the dynamic landscape of a small-to-midsize biotech organization.Key Responsibilities:Program Strategy & Leadership (35%)Formulate and implement clinical program strategies that are aligned with corporate objectives. Lead the Clinical Operations team to optimize the allocation of resources across various programs.Clinical Trial Oversight (25%)Ensure that clinical trials are meticulously defined, planned, and executed in accordance with GCP, ICH, and FDA regulations. Monitor study timelines, budgets, and quality metrics to drive operational excellence.Regulatory & Documentation Support (15%)Assist in drafting key regulatory documents, ensuring that clinical program outputs meet submission requirements and regulatory standards.Vendor & CRO Management (15%)Oversee and manage Contract Research Organizations (CROs), vendors, and external partners to ensure that performance, deliverables, and financial accountability align with expectations.Team Development & Collaboration (10%)Cultivate a collaborative environment within Clinical Operations and exemplify leadership values. Encourage transparent communication, accountability, and operational discipline across the department.Other duties as assigned.

Dec 19, 2025

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Business Operations Associate

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Full-time|On-site|Waltham, Massachusetts, United States

Biocytogen is seeking a Business Operations Associate in Waltham, Massachusetts. This position centers on improving internal processes and supporting ongoing projects within the company. Role overview The Business Operations Associate will work closely with teams to streamline operations and help implement project management strategies. The role involves identifying areas for improvement and contributing to initiatives that strengthen overall business performance. Key responsibilities Support operational process optimization across departments Assist with project management tasks and coordination Contribute to strategic initiatives aimed at improving business outcomes Location This position is based in Waltham, Massachusetts.

Apr 28, 2026

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Associate Director, Pharmacovigilance Scientist

Deciphera Pharmaceuticals, Inc.

Full-time|On-site|Waltham

As the Associate Director of Pharmacovigilance, you will play a crucial role in ensuring the safety and efficacy of our pharmaceutical products. You will lead a team dedicated to monitoring and evaluating adverse drug reactions, while also collaborating closely with regulatory bodies to uphold our commitment to patient safety. Your expertise will contribute significantly to our ongoing efforts in drug development and post-marketing surveillance. Join us in making a difference in the lives of patients around the world.

Apr 6, 2026

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Associate Director of Access Strategy

Sobi

Full-time|On-site|Waltham

As the Associate Director of Access Strategy at Sobi, you will play a pivotal role in shaping the strategies that enhance patient access to our innovative therapies. This position requires a strategic thinker who is passionate about improving healthcare accessibility and is adept at navigating the complexities of the healthcare landscape. You will work closely with cross-functional teams to develop and implement access strategies that align with our organizational goals and promote patient-centric outcomes.

Apr 30, 2026

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Associate Director, Regulatory Affairs CMC

AbbVie Inc.

Full-time|On-site|Waltham

Join AbbVie as an Associate Director in Regulatory Affairs with a focus on Chemistry, Manufacturing, and Controls (CMC). In this pivotal role, you will lead cross-functional teams to ensure compliance with regulatory requirements while advancing our innovative therapies. As a leader, you will drive the development of CMC submission strategies, collaborate with internal and external stakeholders, and support the overall regulatory strategy for our product pipeline.

Apr 30, 2026

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Associate Director of Program Leadership & Management

Deciphera Pharmaceuticals, Inc.

Full-time|On-site|Waltham

Deciphera Pharmaceuticals is excited to invite applications for the role of Associate Director of Program Leadership & Management. In this pivotal position, you will provide exceptional leadership and strategic direction to our Development and Commercial Program Teams. Collaborating closely with the Program Lead, you will be instrumental in advancing programs from early to late-phase clinical development and lifecycle management. The ideal candidate will exhibit a comprehensive understanding of drug development, thrive in ambiguous situations, and possess outstanding communication skills to foster effective collaboration within program teams and across the organization.This role demands a high level of cross-functional teamwork, engaging with both internal and external partners. You will be responsible for leading daily program management activities, including the formulation and implementation of the program's Integrated Development Strategy. A deep understanding of overall program strategy and critical path activities, as well as risk identification and mitigation planning, is essential.Key ResponsibilitiesStrategic Partnership with the Program Lead (50%)Collaborate with the Program Lead to develop and execute strategic, integrated development plans through effective leadership of Program Teams.Provide clear guidance on product development requirements to align with the expectations of external customers and business stakeholders.Monitor program progress and related KPIs, identifying gaps and risks while offering strategic recommendations.Support the execution and ongoing reassessment of development strategies in line with the overall corporate strategy.Operational Excellence Across Program Teams (50%)Facilitate program team meetings to ensure productive and efficient discussions.Ensure timely and clear communication of program strategies and progress to relevant stakeholders.Coordinate the integration of sub-teams to enhance the effectiveness of Program Teams.

Nov 17, 2025

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Associate Director, CMC-Pharma Product Group

AbbVie Inc.

Full-time|On-site|Waltham

May 1, 2026

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Director of Supply Chain Operations at elevatebio | Waltham

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Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics)

Oruka Therapeutics

Full-time|$175K/yr - $200K/yr|Hybrid|Waltham, Massachusetts, United States

About Us:Oruka Therapeutics (Nasdaq: ORKA) is at the forefront of developing innovative biologics aimed at revolutionizing the treatment of chronic skin disorders. Our mission is to empower patients suffering from conditions such as plaque psoriasis by providing opportunities for significant disease clearance with minimal dosing frequency, potentially just once or twice a year. Leveraging a unique portfolio of advanced antibodies engineered by Paragon Therapeutics, we target the fundamental mechanisms contributing to plaque psoriasis and other dermatologic and inflammatory conditions. Learn more about our vision at www.orukatx.com.As we expand our core team, we are seeking passionate professionals who aspire to be part of a transformative journey, not just a job. If you are eager to make a positive impact and contribute to a vibrant, inclusive company culture, we want to hear from you.Job Title: Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics)Location: Hybrid – Waltham, MA, with a requirement to be in-office 3 days a week.Position Overview:We are looking for a dynamic and skilled leader in Manufacturing Science and Technology (MSAT) to spearhead downstream late-stage and pivotal optimization, scale-up, and transfer of manufacturing processes. In this role, you will be responsible for process development, troubleshooting production challenges, data analysis, and ensuring adherence to regulatory standards to uphold product quality. The successful candidate will play a critical role in late-stage drug substance manufacturing and process validation activities to support BLA submissions. This position requires adaptability in a fast-paced environment, along with the ability to draft high-quality reports, finalize source documents, and actively participate in regulatory submissions. Join us as a vital member of a growing team dedicated to advancing best-in-class biotherapeutics.

Mar 30, 2026

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Associate Director of Financial Planning & Analysis

Crescent Biopharma

Full-time|On-site|Waltham, MA

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Apr 21, 2026

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Associate Director of Statistical Programming - Permanent Hybrid Role

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Full-time|Hybrid|United States

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Associate Director/Director of Analytical Development and Validation - Tech Operations (Biologics)

Oruka Therapeutics

Full-time|$182K/yr - $240K/yr|Hybrid|Remote; Waltham, Massachusetts, United States

About Us:Oruka Therapeutics (Nasdaq: ORKA) is pioneering innovative biologic therapies aimed at transforming the treatment landscape for chronic skin conditions. Our mission is to empower individuals suffering from chronic skin diseases, such as plaque psoriasis, by providing unprecedented freedom from their ailments through treatments administered as infrequently as once or twice a year. We are advancing a proprietary portfolio of potentially best-in-class antibodies developed by Paragon Therapeutics, targeting the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory disorders. For more details, visit www.orukatx.comAs we fortify our core team, we are on the lookout for exceptional talent across various domains. We seek individuals who are not just looking for employment, but are eager to contribute to a larger purpose. If you are passionate about making a significant impact and are keen on fostering an engaged, inclusive, and positive workplace culture, we want to hear from you.Job Title: Associate Director/Director of Analytical Development and Validation - Tech Operations (Biologics)Location: Hybrid – Waltham, MA. Candidates are expected in the office 3 days a week. Remote considerations may apply.Role Overview:The Associate Director/Director of Analytical Development and Validation will provide scientific and strategic leadership for late-stage analytical activities that support the development, validation, and lifecycle management of biologic drug products, particularly monoclonal antibodies. This position will oversee method validation and comparability initiatives essential for BLA/MAA submissions, process modifications, and commercial readiness, collaborating closely with CMC, Quality, Regulatory Affairs, and external partners.The ideal candidate is a proactive leader with extensive experience in analytical method validation, device functional testing, and regulatory frameworks for late-stage biologics. You will guide teams through intricate technical and compliance milestones, making this a highly visible role within the CMC team. Join our expanding organization and play a crucial part in supporting multiple programs’ analytical activities, facilitating the release of supplies for clinical trials, and preparing for commercialization in the US, Canada, and EU.

Apr 10, 2026

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Laboratory Operations Associate at Biocytogen | Waltham, MA

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Full-time|On-site|Waltham, Massachusetts, United States

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Apr 6, 2026

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Senior Manager/Associate Director of Marketing Operations

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Full-time|$175K/yr - $200K/yr|On-site|Waltham, Massachusetts, United States

About Us: Cogent Biosciences is a publicly traded biotechnology firm dedicated to pioneering innovative precision therapies aimed at addressing significant medical needs across diverse patient populations. Our flagship product, bezuclastinib, is engineered to effectively inhibit exon 17 mutations in the KIT receptor tyrosine kinase, particularly the KIT D816V mutation, which is implicated in Systemic Mastocytosis and gastrointestinal stromal tumors (GIST). We have observed promising initial results from our clinical trials (APEX, SUMMIT, PEAK), showcasing a favorable safety profile across over 600 patients receiving both monotherapy and combination treatments. The Opportunity: We are seeking a dynamic individual for the pivotal role of Senior Manager/Associate Director of Marketing Operations. This position will oversee the execution of strategic marketing operations to facilitate the launch of bezuclastinib, ensuring efficient, compliant, and impactful delivery of promotional materials and omnichannel campaigns. You will work closely with brand leaders to create a unified promotional strategy that enhances customer experience, drives brand performance, and supports commercial growth. Key Responsibilities: Omnichannel Campaign Management: Collaborate with the marketing team to develop and implement complex customer engagement strategies across healthcare professionals, patients, and caregivers. Partner with analytics teams to incorporate insights into campaign design and continuous improvement. Ensure readiness of systems and platforms for tracking key performance metrics and campaign effectiveness. Utilize data and segmentation strategies to ensure personalized outreach to target audiences. Promotional Review and Content Approval: Oversee the internal promotional review process (MLR) and navigate the content approval path for key commercial materials.

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Feb 2, 2026

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Associate Director, Medical Science Liaison (MSL), Rheumatology

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Full-time|$181.6K/yr - $227K/yr|On-site|Waltham, MA

Zenas Bio is a pioneering clinical-stage global biopharmaceutical company dedicated to revolutionizing the treatment landscape for patients suffering from autoimmune diseases. Our strategic approach is rooted in the expertise of our seasoned leadership team, combined with a rigorous methodology for acquiring and developing promising product candidates worldwide. We are advancing two late-stage molecules, obexelimab and orelabrutinib, which we believe have the potential to provide significant clinical benefits. Obexelimab, our flagship candidate, is a bifunctional monoclonal antibody targeting both CD19 and FcγRIIb, designed to inhibit the activity of B cells implicated in various autoimmune diseases while preserving them. The unique administration method of obexelimab as a self-injected subcutaneous treatment may effectively tackle the underlying mechanisms involved in chronic autoimmune conditions. Orelabrutinib stands out as a potentially best-in-class oral Bruton’s Tyrosine Kinase (BTK) inhibitor, offering a highly selective approach to managing CNS-penetrant inflammation and disease progression in Multiple Sclerosis (MS). Additionally, Zenas is developing early-stage candidates, including an innovative oral IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor, both showing promise in the field.We are in search of exceptional talent who share our dedication to improving patient outcomes and possess a proven track record in the global acquisition, development, and commercialization of pharmaceutical products. Join our fast-paced environment where you will have the chance to grow both personally and professionally while contributing to our mission of leading the charge in immunology and autoimmune disease treatment, grounded in our core values of Transparency, Relationships, Urgency, Excellence, and TRUE Innovation!Territory: MidAtlantic (NY, NJ, PA, OH)Position Summary:The Associate Director, Medical Science Liaison (MSL) for Rheumatology at Zenas Bio serves as the field-based representative of our Medical Affairs team. MSLs are scientifically trained professionals with robust clinical and scientific backgrounds, committed to providing the healthcare community with balanced, scientifically rigorous information. This role reports directly to the Executive National Director of US MSLs.Key Responsibilities:Identify, establish, and nurture professional relationships with international, national, regional, and local key opinion leaders and allied healthcare professionals.

Apr 7, 2026

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