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We are looking for candidates with a robust background in pharmacovigilance or drug safety, ideally with a Master’s degree or higher in a relevant field. A minimum of 5 years of experience in the pharmaceutical industry is required, with a strong emphasis on regulatory compliance and reporting. You should possess excellent analytical skills, attention to detail, and the ability to work collaboratively in a fast-paced environment.
About the job
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.
About Deciphera Pharmaceuticals, Inc.
Deciphera Pharmaceuticals, Inc. is at the forefront of transforming the treatment landscape for patients with cancer. We focus on developing innovative therapies that target the underlying mechanisms of disease. Our commitment to scientific excellence and patient safety drives our work, and we are seeking passionate individuals to join our mission.
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 o…
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.
Full-time|$213K/yr - $286K/yr|Hybrid|Waltham, Massachusetts, United States
Join Our Mission:Oruka Therapeutics (Nasdaq: ORKA) is at the forefront of developing cutting-edge biologics aimed at revolutionizing the treatment of chronic skin diseases. Our commitment is to provide patients afflicted by conditions such as plaque psoriasis with unprecedented freedom by achieving significant disease clearance with infrequent dosing—sometimes as little as once or twice a year. We are advancing a proprietary pipeline of potentially best-in-class antibodies that target the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory ailments. Discover more about us at www.orukatx.com.As we expand our core team, we are looking for exceptional individuals who are not just seeking employment but are passionate about contributing to a broader cause. We value candidates who are eager to foster an inclusive and dynamic company culture.Position Overview:We are in search of a seasoned and motivated leader in regulatory CMC to shape our strategy and execution across various stages of biologics programs. In this role, you will be responsible for the development of high-quality regulatory CMC submissions and will provide guidance to cross-functional teams on global regulatory expectations appropriate for different phases. Ideal candidates will bring extensive expertise in biologics development and manufacturing, particularly in drug substance and product CMC submissions. You will play a crucial role in influencing program strategies, facilitating collaboration across CMC, QA, RA, Supply Chain, and external partners, and driving pivotal decisions that support our expanding biologics pipeline. This highly visible role involves ensuring compliance with FDA, EMA, ICH, and WHO guidelines while meeting corporate and program-level objectives.
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.
Full-time|$130K/yr - $208K/yr|Hybrid|Waltham, Massachusetts, United States
About Oruka Therapeutics Oruka Therapeutics (Nasdaq: ORKA) develops biologics for chronic skin conditions. The company’s mission centers on helping patients with diseases like plaque psoriasis achieve lasting relief, aiming for high rates of disease clearance with infrequent dosing, sometimes just once or twice a year. Oruka’s portfolio features proprietary antibodies from Paragon Therapeutics that target the underlying mechanisms of plaque psoriasis and other dermatologic or inflammatory disorders. More information is available at www.orukatx.com. Role Overview: Scientist/Senior Scientist, Upstream Process Development & Manufacturing (Biologics) Oruka Therapeutics is hiring a Scientist or Senior Scientist to support upstream manufacturing operations in Waltham, Massachusetts. This position focuses on process development and the delivery of clinical trial materials produced at Contract Development and Manufacturing Organizations (CDMOs). The role works closely with the CMC team and collaborates with colleagues in downstream processing, analytical development, drug product, Quality Assurance, regulatory affairs, and program management. This position contributes to CMC strategy and supports the development of biotherapeutics in an innovative and growing team environment.
We are seeking a passionate and detail-oriented Associate Research Scientist to join our innovative team at mindlance2. In this role, you will contribute to groundbreaking research initiatives, collaborating with a team of experts to drive scientific discovery.
About Vita Global SciencesAt Softworld's Vita Global Sciences, we excel in providing professional services tailored to the life sciences sector. Our expertise includes clinical data analytics solutions and functional outsourcing services. Our dedicated team is skilled in Clinical Data Management, Regulatory Submissions, Biostatistics, Statistical Programming, Data Analytics, and PK/PD analysis. We pride ourselves on our steadfast commitment to delivering outstanding results in a safe, compliant, and efficient manner.Our Ideal Candidate:We are looking for a dynamic Director of Business Development to lead the growth of our Life Sciences division from a remote setting. The successful candidate will adeptly manage geographic territories, identify and cultivate promising leads, craft persuasive proposals, and deliver influential presentations. Our primary focus is to provide exceptional consulting services to our esteemed clients. This role demands a high degree of professionalism and expertise, and we are excited to find an individual who can significantly contribute to achieving our objectives.
Full-time|$129K/yr - $209K/yr|On-site|Waltham, Massachusetts, United States
Join Our Team!Become a pivotal member of the Evolv Machine Learning & Sensors team as a Senior Data Scientist. In this role, you will delve into sensor data, explore feature spaces, and ensure data quality that fuels our cutting-edge AI/ML systems. This hands-on position focuses on representation analysis, extracting exploratory data insights, and implementing data-centric enhancements that significantly elevate model accuracy, robustness, and generalization. You will navigate through classical ML and deep learning pipelines to uncover blind spots, diagnose data challenges, and shape effective data curation and collection strategies.Your Path to Success: Key Outcomes in the First YearFirst 30 Days:Gain a comprehensive understanding of Evolv’s sensor ecosystem, datasets, and ML pipelines.Analyze dataset structure, labeling processes, and existing exploratory data analyses.Conduct initial UMAP/PCA/t-SNE analyses to visualize data distributions and detect anomalies.Spot opportunities to enhance data quality, labeling consistency, and dataset coverage.First 90 Days:Engage in deep representation analysis across sensor, time-series, and feature data.Evaluate classical ML and deep learning models by correlating model errors with data quality issues.Establish data quality metrics and initial dataset acceptance criteria.Collaborate with data collection teams to inform targeted data acquisition and relabeling efforts.Mine existing field data to recognize patterns and derive actionable insights.Devise methodologies to enhance data quality, transforming noisy or unverified data into clean, validated datasets.End of Year Goals:Own data-driven insights that lead to measurable improvements in ML model performance.Establish continuous monitoring for data drift, blind spots, and label quality.Offer strategic direction for future data collection, annotation, and curation.Create automated tools and dashboards for data quality reporting and representation analysis.Your Daily ResponsibilitiesData Understanding & Representation Analysis:Analyze high-dimensional sensor and feature data utilizing UMAP, t-SNE, PCA, and similar techniques.Identify clusters, outliers, distribution gaps, and blind spots within various classes and environments.Diagnose dataset shifts, domain mismatches, sparsity, and representation collapse.Model-Aware Data Analysis:Conduct data analyses that align with both classical ML models (XGBoost, SVR, k-NN, tree-based models) and deep learning frameworks (CNNs, Transformers).Investigate embeddings, confusion matrices, and failure cases to connect model issues back to data causes.Join Us at Evolv TechnologyAt Evolv Technology, we are dedicated to revolutionizing the way people experience spaces through intelligent sensor technology and advanced machine learning. We foster a collaborative environment where creativity and innovation thrive. Join us as we push the boundaries of technology to create safer and more efficient environments.
Full-time|$161K/yr - $187K/yr|Hybrid|Waltham, Massachusetts, United States
Oruka Therapeutics develops biologic treatments for chronic skin conditions, including plaque psoriasis. The company’s approach centers on infrequent dosing and proprietary antibodies designed to address dermatologic and inflammatory disorders. Oruka is headquartered in Waltham, Massachusetts, and operates as a publicly traded company (Nasdaq: ORKA). Role overview The Senior Manager, Clinical Supply Chain (Biologics) leads supply chain operations for clinical trials spanning early to late development stages. This hybrid role is based in Waltham, MA, with an on-site presence required three days per week. The position reports to the head of Clinical Supply Chain and supports multiple trials in the US, Canada, and the EU. Key responsibilities include managing labeling, packaging, distribution, inventory, forecasting, and handling supply expiration. The Senior Manager also oversees IRT (Interactive Response Technology) initiation and maintenance. Collaboration with CMC, Clinical, Program Management, Regulatory, and Quality teams is central to the work, as is helping to establish supply chain best practices and processes. The scope covers global activities, with particular attention to supplies such as vials and pre-filled syringes. Key responsibilities Carry out clinical supply chain tasks, including labeling, packaging, and inventory management. Oversee distribution, forecasting, and supply expiration for clinical trials. Initiate and maintain IRT systems to support trial operations. Work closely with cross-functional teams to ensure alignment and compliance. Support development and implementation of supply chain processes and best practices. Requirements Experience managing clinical supply chain operations for biologics, ideally across multiple regions. Strong communication skills and a results-oriented approach. Ability to work effectively with cross-functional teams and external partners. Familiarity with clinical trial supply needs, especially for vials and pre-filled syringes. Hybrid work schedule: in-office presence in Waltham, MA, three days per week. For more about Oruka Therapeutics, visit www.orukatx.com.
Full-time|$191K/yr - $253K/yr|On-site|Waltham, Massachusetts, United States
Anduril Industries is at the forefront of defense technology, dedicated to enhancing the military capabilities of the U.S. and its allies through innovative advancements. By integrating the expertise and models of today's most progressive companies into the defense sector, Anduril is revolutionizing the design, production, and sale of military systems. Our systems are powered by Lattice OS, an AI-driven operating system that transforms numerous data streams into a real-time, 3D command and control center. As we navigate an era of strategic competition, Anduril is devoted to delivering state-of-the-art autonomy, AI, computer vision, sensor fusion, and networking technologies to the military in a fraction of the time previously thought possible.ABOUT THE TEAMThe Imaging Business Line within the Mission Systems Division focuses on solving complex challenges in computer vision, perception, electro-optical, infrared, and sensor data. This team engineers cutting-edge imaging systems across both hardware and software, providing solutions to the most pressing security challenges faced by the U.S. and its allies. Our Imaging team operates out of Waltham, Massachusetts.ABOUT THE JOBThe Director of Imaging (Emerging Technology) position is integral to the Imaging Business Development (BD) team, tasked with discovering, shaping, capturing, and expanding new opportunities and capabilities. To effectively address both current and future client needs, the team must possess a deep understanding of user pain points, the inadequacies of existing solutions, and how Anduril's products can facilitate superior mission outcomes. BD team members act as a conduit between clients and the larger Anduril team, conveying client insights across the organization while also serving as external ambassadors of the Anduril brand. The Imaging BD team collaborates closely with programs, engineering, and leadership to ensure that Anduril’s products not only meet but exceed client expectations and mission requirements, driving continuous enhancements in response to evolving client needs and operational landscapes. Additionally, the Imaging BD team engages with other divisions and business lines within Anduril to deliver integrated, best-in-class systems to our customers.WHAT YOU'LL DODevelop a comprehensive, data-driven strategy to engage with the U.S. Marine Corps, U.S. Navy, U.S. Army, U.S. Air Force, U.S. SOCOM, and other key agencies to expand and scale the Imaging Emerging Technology Portfolio.Foster and maintain robust relationships with pivotal stakeholders to identify and shape new business opportunities, effectively communicating the value of Anduril's solutions.
Full-time|$181.6K/yr - $227K/yr|On-site|Waltham, MA
Zenas Bio is an innovative clinical-stage biopharmaceutical company focused on transforming the treatment landscape for patients with autoimmune diseases. Our strategic approach blends a seasoned leadership team with a meticulous product acquisition strategy, enabling us to identify, acquire, and develop promising therapies that deliver exceptional clinical benefits. Currently, we are progressing two late-stage molecules: obexelimab and orelabrutinib. Obexelimab is our flagship candidate, a bifunctional monoclonal antibody targeting CD19 and FcγRIIb to modulate B cell activity in autoimmune diseases without cell depletion. Orelabrutinib is a highly selective, oral Bruton’s Tyrosine Kinase (BTK) inhibitor designed to penetrate the central nervous system and address inflammation in Multiple Sclerosis. Additionally, we are advancing a pipeline that includes a preclinical IL-17AA/AF inhibitor and a TYK2 inhibitor. We invite passionate individuals to join our mission of elevating patient care through groundbreaking research and innovation. At Zenas Bio, you will thrive in a dynamic environment that values Transparency, Relationships, Urgency, Excellence, and Innovation—our core values of TRUE Innovation!Territory: US - EastPosition Summary:The Associate Director, Medical Science Liaison (MSL) for Neurology will serve as a vital field-based extension of our Medical Affairs team. MSLs are highly trained professionals with robust clinical and scientific expertise, dedicated to providing fair and balanced information to the healthcare community. This role reports directly to the Director of MSLs in Neurology.Key Responsibilities:Forge and sustain professional relationships with key opinion leaders and healthcare professionals at international, national, regional, and local levels.
Full-time|$213K/yr - $286K/yr|Hybrid|Menlo Park, California, United States; Remote; Waltham, Massachusetts, United States
About Oruka Therapeutics Oruka Therapeutics (Nasdaq: ORKA) develops biologics for chronic skin conditions, with a focus on achieving strong disease clearance through infrequent dosing, sometimes as little as once or twice per year. The company’s pipeline includes antibodies engineered by Paragon Therapeutics that target the underlying mechanisms of plaque psoriasis and other dermatological and inflammatory diseases. Learn more at www.orukatx.com. Role Overview Title: Director / Senior Director, Regulatory Affairs Strategy Location: Hybrid preferred (Menlo Park, CA or Waltham, MA). Remote considered. This position serves as Global Regulatory Lead for one or more development programs and reports directly to the Vice President of Regulatory Affairs. The Director/Senior Director will define and execute regulatory strategies to support the global advancement of Oruka’s biologics, with a focus on immunology and dermatology programs. What You Will Do Lead regulatory strategy for assigned programs, translating product goals into actionable development and registration plans. Drive key regulatory milestones and oversee major submissions. Represent Oruka in interactions with health authorities. Identify regulatory risks and opportunities in alignment with company objectives. Collaborate across functions to ensure high-quality, timely global development of the portfolio. What Sets This Role Apart This is a visible leadership role with influence over the regulatory direction of programs aiming for infrequent dosing, strong efficacy, and lasting results in psoriasis and related conditions. The position offers the chance to shape strategies for a pipeline of engineered antibodies intended to change how chronic skin diseases are treated.
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.
Full-time|$138K/yr - $222K/yr|On-site|Waltham, Massachusetts, United States
Elevator PitchThe Director of Strategic Programs serves as a vital strategic ally to the CFO, overseeing comprehensive project management that includes M&A sourcing through integration, implementing change management for system upgrades, prioritizing budgets, and leading an enterprise PMO that facilitates transformative initiatives across the organization. In this role, you will be instrumental in managing the CFO’s operational framework, spearheading critical company-wide programs, and conducting business reviews focused on ROI that align with C-Suite objectives.Success in the Role (First 6–12 Months)In the first 30 days, you will:Establish strong connections with key stakeholders and partners, including the Executive Leadership Team, Finance, and other senior leaders.Align with CFO priorities, business rhythms, and the operational calendar (planning, forecasts, ELT/Board cycles, etc.).Implement functional reviews for strategic initiatives and budget planning.Within 90 days, you will:Initiate the organic investment review (ROIC model, tiered scorecards) to inform start/stop/continue decisions.Set up the Enterprise PMO cadence across IT projects, Contract Manufacturing change management, M&A funnel, and targeted value projects (e.g., software subscription expenditure reduction, indirect procurement, off-shoring).By the end of 12 months, you will:Deliver quantifiable ROI productivity (portfolio rebalanced; ROIC enhancement; cycle time reduction).Advance at least one M&A transaction through the stage gate process with a comprehensive Post Merger Integration plan.Achieve key transformation milestones with KPI improvements aligned with company objectives.Ensure service SLAs are met; maintain CFO time alignment above 85% on top priorities.The Work (What You’ll Do):Strategy & Internal Capital InvestmentLead the annual and long-range planning process alongside the CFO and CEO; translate strategic objectives into OKRs and decision memos.Manage internal operations and organic investment reviews utilizing ROIC/NPV scorecards; recommend rebalancing actions and ensure follow-through with the ELT.Collaborate with the ELT and junior staff across all functions to achieve related company goals.M&A / Corporate DevelopmentDevelop theses and maintain a target pipeline with the ELT; ensure consistent deal cadence and reporting.
Full-time|$73K/yr - $117K/yr|On-site|Waltham, Massachusetts, United States
The Elevator PitchAre you an expert in navigating the complexities of state, local, and indirect tax compliance? Do you possess the organizational skills and knowledge necessary to manage tax filings, exemptions, and inquiries? If so, we invite you to consider the role of Senior Tax Associate at evolv Technology.In this position, you will take charge of indirect tax compliance and property tax reporting processes, while serving as the primary liaison for all tax-related inquiries. While tax expertise varies, you will be the go-to person for tax questions across the organization.Success in the Role: What are performance outcomes over the first 6-12 months you will work toward completing?In the first 30 days, you will:Prepare and submit property tax returns on behalf of the company.Manage and file all sales tax returns to ensure compliance and accuracy.Learn and oversee the Tax Exemption Certificate process.Ensure timely payment for all tax obligations across different types.Support the payroll department with any payroll tax-related inquiries.Within 3 months, you will:Build relationships with external tax advisors.Assist in gathering information for corporate income tax accounting and return preparation.Prepare journal entries and reconcile tax-related accounts in the general ledger.Support quarterly and annual external audits.Help prepare financial statement disclosures.Address any outstanding tax notices or audits.By the end of the first year, you will:Become the first point of contact for all tax-related matters, including supporting Federal and State tax returns, and addressing any tax inquiries.Lead efforts on resolving open tax notices and audits.
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.
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.
Full-time|$125K/yr - $165K/yr|On-site|Waltham, Massachusetts, United States
At ElevateBio, we are a pioneering technology company at the forefront of advancing the life sciences. We empower our partners to unlock the full potential of their therapies, guiding them from initial design through to successful commercialization. Our unique blend of innovative technologies, comprehensive services, and unparalleled manufacturing expertise enables us to accelerate the development of cutting-edge therapies efficiently and effectively. The Opportunity:We are seeking a talented Manufacturing Execution System (MES) Engineer II to join our dynamic team. Reporting directly to the Associate Director of Operational Technology, you will play a crucial role in supporting and optimizing our Manufacturing Execution System. As an experienced member of the MES team, you will help us enhance our capabilities as a Contract Development and Manufacturing Organization (CDMO). This position may involve some supervisory responsibilities as delegated.Your Responsibilities:Collaborate with the MES team and Manufacturing Operations:Provide expert support to the MES team, ensuring the successful execution of all related activities.Assist Senior MES Engineers with MES initiatives and projects.Identify and implement process improvements for MES team efficiency and effectiveness.Deliver technical support for manufacturing operations, including on-call assistance and troubleshooting MES issues with software vendors.Manage administrative duties for the MES system, including user access, system configurations, and security settings.Mentor junior MES engineers and foster a collaborative, innovative, and respectful work environment.Perform additional duties as assigned.Logbook & Batch Record Templates and Tech Transfer Support:Design, develop, and test templates for Electronic Batch Records (EBRs) and Electronic Logbooks (eLogs).Establish best practices for template design in collaboration with Manufacturing and Science Technology (MSAT), Manufacturing (MFG), and Quality Assurance (QA).Enhance the template design and testing strategy.Assist stakeholders and clients in understanding MES requirements during tech transfer projects, including change management and template development timelines.
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.
Deciphera Pharmaceuticals, Inc. is on the lookout for a seasoned Associate Director of Sales Operations to spearhead and enhance our field-facing operational strategies. This pivotal role will support the establishment of a high-performing Commercial field team, particularly focused on facilitating a successful brand launch. The successful candidate will ensure compliance, efficiency, and data-driven insights within field operations across our Hematology Franchise, playing a crucial role in ensuring operational readiness for product launches and ongoing excellence initiatives in the field.Key ResponsibilitiesFormulate and implement field operations strategies that align with both commercial and medical objectives.Manage field technology platforms including CRM systems, roster management, and reporting tools in collaboration with the IT department.Oversee territory design, roster management, and alignment processes to ensure compliance with coverage models.Coordinate onboarding operations with Training, HR, and Compliance teams.Direct the creation of field reports, dashboards, KPI tracking, and business insights.Ensure all field operations processes adhere to FDA, OIG, and corporate compliance standards.Lead continuous improvement initiatives aimed at enhancing scalability, efficiency, and quality.Collaborate effectively across functions including Sales, Marketing, Medical, Compliance, IT, HR, Legal, and Finance.
